New cantharidin formulation alleviates molluscum contagiosum in pivotal trials

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A novel, standardized preparation of topical cantharidin effectively cleared lesions in patients with molluscum contagiosum, compared with placebo, according to the results of two trials presented at the annual meeting of the American Academy of Dermatology.

VP-102, a drug-device combination, was well tolerated and was not associated with serious adverse events.

No Food and Drug Administration–approved treatment is available for treating molluscum contagiosum, which is routinely treated with cantharidin, a naturally occurring vesicant.

VP-102 is a novel formulation of 0.7% cantharidin solution, provided in a single-use applicator, to provide consistent delivery and long-term drug stability.

To test the efficacy and safety of VP-102, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and his associates conducted the CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2 phase 3 studies, which had similar designs. The studies enrolled patients with molluscum contagiosum aged 2 years and older who had not received any treatment in the 2 weeks before enrollment. Patients were randomized to VP-102 or vehicle for 12 weeks. Treatment was administered topically to each lesion every 3 weeks for a maximum of four applications, and washed off with soap and warm water 24 hours after application.

The trials’ primary endpoint was the percentage of patients with complete clearance of their lesions. Secondary endpoints were the percentage of patients with complete clearance at 3, 6, and 9 weeks, and decrease in lesions over time. The researchers also assessed safety and tolerability.


In the two studies, 528 patients aged 2-60 years (mean age, approximately 7 years) were randomized to treatment or vehicle. About 30% of participants had prior treatment. The baseline lesion count ranged from 1 to 184.

At day 84, the proportion of patients in the VP-102 arm who achieved complete clearance of lesions was 46% in CAMP-1 and 54% in CAMP-2, compared with 18% and 13%, respectively, among controls (P less than .0001). By day 84, among treated patients, the lesion count had decreased by a mean of 69% in CAMP-1 and 83% in CAMP-2, compared with 20% and 19%, respectively, among controls. Results among controls were “probably consistent with natural history,” Dr. Eichenfield observed.

The researchers observed a high incidence of treatment-emergent adverse events among patients receiving VP-102. “Any crust or vesiculation was considered to be a treatment-emergent adverse event,” Dr. Eichenfield said. Most adverse events were mild, although five patients discontinued the studies because of treatment-emergent adverse events. Vesiculation was a common adverse event in the VP-102 group; pruritus and application-site pain were reported as well.

Verrica Pharmaceuticals developed VP-102 and funded the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica, which plans to submit for FDA approval in the second half of 2019.

SOURCE: Eichenfield L et al. AAD 19, Abstract 11251.

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A novel, standardized preparation of topical cantharidin effectively cleared lesions in patients with molluscum contagiosum, compared with placebo, according to the results of two trials presented at the annual meeting of the American Academy of Dermatology.

VP-102, a drug-device combination, was well tolerated and was not associated with serious adverse events.

No Food and Drug Administration–approved treatment is available for treating molluscum contagiosum, which is routinely treated with cantharidin, a naturally occurring vesicant.

VP-102 is a novel formulation of 0.7% cantharidin solution, provided in a single-use applicator, to provide consistent delivery and long-term drug stability.

To test the efficacy and safety of VP-102, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and his associates conducted the CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2 phase 3 studies, which had similar designs. The studies enrolled patients with molluscum contagiosum aged 2 years and older who had not received any treatment in the 2 weeks before enrollment. Patients were randomized to VP-102 or vehicle for 12 weeks. Treatment was administered topically to each lesion every 3 weeks for a maximum of four applications, and washed off with soap and warm water 24 hours after application.

The trials’ primary endpoint was the percentage of patients with complete clearance of their lesions. Secondary endpoints were the percentage of patients with complete clearance at 3, 6, and 9 weeks, and decrease in lesions over time. The researchers also assessed safety and tolerability.


In the two studies, 528 patients aged 2-60 years (mean age, approximately 7 years) were randomized to treatment or vehicle. About 30% of participants had prior treatment. The baseline lesion count ranged from 1 to 184.

At day 84, the proportion of patients in the VP-102 arm who achieved complete clearance of lesions was 46% in CAMP-1 and 54% in CAMP-2, compared with 18% and 13%, respectively, among controls (P less than .0001). By day 84, among treated patients, the lesion count had decreased by a mean of 69% in CAMP-1 and 83% in CAMP-2, compared with 20% and 19%, respectively, among controls. Results among controls were “probably consistent with natural history,” Dr. Eichenfield observed.

The researchers observed a high incidence of treatment-emergent adverse events among patients receiving VP-102. “Any crust or vesiculation was considered to be a treatment-emergent adverse event,” Dr. Eichenfield said. Most adverse events were mild, although five patients discontinued the studies because of treatment-emergent adverse events. Vesiculation was a common adverse event in the VP-102 group; pruritus and application-site pain were reported as well.

Verrica Pharmaceuticals developed VP-102 and funded the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica, which plans to submit for FDA approval in the second half of 2019.

SOURCE: Eichenfield L et al. AAD 19, Abstract 11251.

A novel, standardized preparation of topical cantharidin effectively cleared lesions in patients with molluscum contagiosum, compared with placebo, according to the results of two trials presented at the annual meeting of the American Academy of Dermatology.

VP-102, a drug-device combination, was well tolerated and was not associated with serious adverse events.

No Food and Drug Administration–approved treatment is available for treating molluscum contagiosum, which is routinely treated with cantharidin, a naturally occurring vesicant.

VP-102 is a novel formulation of 0.7% cantharidin solution, provided in a single-use applicator, to provide consistent delivery and long-term drug stability.

To test the efficacy and safety of VP-102, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and his associates conducted the CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2 phase 3 studies, which had similar designs. The studies enrolled patients with molluscum contagiosum aged 2 years and older who had not received any treatment in the 2 weeks before enrollment. Patients were randomized to VP-102 or vehicle for 12 weeks. Treatment was administered topically to each lesion every 3 weeks for a maximum of four applications, and washed off with soap and warm water 24 hours after application.

The trials’ primary endpoint was the percentage of patients with complete clearance of their lesions. Secondary endpoints were the percentage of patients with complete clearance at 3, 6, and 9 weeks, and decrease in lesions over time. The researchers also assessed safety and tolerability.


In the two studies, 528 patients aged 2-60 years (mean age, approximately 7 years) were randomized to treatment or vehicle. About 30% of participants had prior treatment. The baseline lesion count ranged from 1 to 184.

At day 84, the proportion of patients in the VP-102 arm who achieved complete clearance of lesions was 46% in CAMP-1 and 54% in CAMP-2, compared with 18% and 13%, respectively, among controls (P less than .0001). By day 84, among treated patients, the lesion count had decreased by a mean of 69% in CAMP-1 and 83% in CAMP-2, compared with 20% and 19%, respectively, among controls. Results among controls were “probably consistent with natural history,” Dr. Eichenfield observed.

The researchers observed a high incidence of treatment-emergent adverse events among patients receiving VP-102. “Any crust or vesiculation was considered to be a treatment-emergent adverse event,” Dr. Eichenfield said. Most adverse events were mild, although five patients discontinued the studies because of treatment-emergent adverse events. Vesiculation was a common adverse event in the VP-102 group; pruritus and application-site pain were reported as well.

Verrica Pharmaceuticals developed VP-102 and funded the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica, which plans to submit for FDA approval in the second half of 2019.

SOURCE: Eichenfield L et al. AAD 19, Abstract 11251.

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Key clinical point: VP-102 is an effective treatment for molluscum contagiosum.

Major finding: In two studies, 46% and 54% of actively treated patients had complete resolution, compared with 13% and 18% of controls, respectively.

Study details: Two phase 3, randomized, double-blind, placebo-controlled trials of 528 patients with molluscum contagiosum.

Disclosures: Verrica Pharmaceuticals sponsored the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica Pharmaceuticals.Source: Eichenfield L et al. AAD 19, Abstract 11251.

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Up-close view of climate change proves sobering

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Dr. Carl Bell steps away from American College of Psychiatrists meeting and gets a jolt

 

It used to be difficult to conceive of writing about climate change in light of the illnesses we psychiatrists treat. But talking about climate change has become unavoidable. Sometimes, it seems that things weigh heavy on my heart, and I have to write about them – especially when it is serious.

Dr. Carl C. Bell

David Alan Pollack, MD, has been talking about climate change for some years now, and while I understood his concern, I had yet to see the psychological effects up close and personal. After all, I live in Chicago, and we are surrounded by concrete and asphalt.

Thankfully, I also travel, and I get a chance to get into nature. While in Hawaii at the American College of Psychiatrists annual meeting in February, I went snorkeling in Hanauma Bay. I saw coral and fish. The problem is I have a very vivid memories of snorkeling in that exact same nature preserve, which also was a Marine Life Conservation District in 1972 while I was attending the American Psychiatric Association annual meeting.

The contrast between the two experiences leaves me with a glum, sad, disappointed, heart-broken feeling because it was an intimate and personal experience with climate change. In 1972, I saw every type of coral imaginable: brain coral, club finger coral, elk coral, great star coral, pillar coral, staghorn coral, table coral, and tube coral. If I remember correctly, there were corky sea fingers and sea fans, but not sea turtles. In 1972, I saw bigeyefish, damselfish, doctorfish, filefish, goatfish, gobies, hogfish, lemon butterflyfish, lizardfish, parrottfish, porcupinefish, pufferfish, queen angelfish, rock beauties, sergeant majors, soldierfish, spot-tail spot-tail butterflyfish, Spanish hogfish, squirrelfish, tangs, trunkfish, or any bluehead or yellowhead wrasses.



In 2019, I saw two pieces of coral less that 9 inches in diameter and not a single sea urchin. There were maybe three types of tropical fish that I was unfamiliar with seeing. The difference between what I saw in 1972 and what I saw in 2019 was like the difference between the rain forest in Puerto Rico and the dunes of the Sahara Desert.

Sure, I have heard David talk about the mental health effects of climate change on stress, anxiety, and depression, and I have always thought that he was right. But to see climate change up close and personal is a sobering experience. Lately, I have found myself apologizing to children I know. I apologize to them for being part of the system and process that is destroying the planet – and leaving them with a hot mess.

At this point, it seems to me that we cannot just try to save the planet by being better stewards of our garbage and pointing out measurable indicators of climate change. We need to actively rather than passively try to save the planet. Of course, the question is who will pay for the active efforts to depollute Earth. From what I saw for myself in Hanauma Bay, I don’t think we have much time. So I am hoping that more people will take the issue of climate change seriously.

Dr. Bell is a staff psychiatrist at Jackson Park Hospital’s Medical/Surgical-Psychiatry Inpatient Unit in Chicago, clinical psychiatrist emeritus in the department of psychiatry at the University of Illinois at Chicago, former president/CEO of Community Mental Health Council, and former director of the Institute for Juvenile Research (birthplace of child psychiatry), also in Chicago. Check out Dr. Bell’s new book, “Fetal Alcohol Exposure in the African-American Community,” at https://thirdworldpressfoundation.org/product/pre-order-fetal-alcohol-exposure-in-the-african-american-community/.
 

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Dr. Carl Bell steps away from American College of Psychiatrists meeting and gets a jolt

Dr. Carl Bell steps away from American College of Psychiatrists meeting and gets a jolt

 

It used to be difficult to conceive of writing about climate change in light of the illnesses we psychiatrists treat. But talking about climate change has become unavoidable. Sometimes, it seems that things weigh heavy on my heart, and I have to write about them – especially when it is serious.

Dr. Carl C. Bell

David Alan Pollack, MD, has been talking about climate change for some years now, and while I understood his concern, I had yet to see the psychological effects up close and personal. After all, I live in Chicago, and we are surrounded by concrete and asphalt.

Thankfully, I also travel, and I get a chance to get into nature. While in Hawaii at the American College of Psychiatrists annual meeting in February, I went snorkeling in Hanauma Bay. I saw coral and fish. The problem is I have a very vivid memories of snorkeling in that exact same nature preserve, which also was a Marine Life Conservation District in 1972 while I was attending the American Psychiatric Association annual meeting.

The contrast between the two experiences leaves me with a glum, sad, disappointed, heart-broken feeling because it was an intimate and personal experience with climate change. In 1972, I saw every type of coral imaginable: brain coral, club finger coral, elk coral, great star coral, pillar coral, staghorn coral, table coral, and tube coral. If I remember correctly, there were corky sea fingers and sea fans, but not sea turtles. In 1972, I saw bigeyefish, damselfish, doctorfish, filefish, goatfish, gobies, hogfish, lemon butterflyfish, lizardfish, parrottfish, porcupinefish, pufferfish, queen angelfish, rock beauties, sergeant majors, soldierfish, spot-tail spot-tail butterflyfish, Spanish hogfish, squirrelfish, tangs, trunkfish, or any bluehead or yellowhead wrasses.



In 2019, I saw two pieces of coral less that 9 inches in diameter and not a single sea urchin. There were maybe three types of tropical fish that I was unfamiliar with seeing. The difference between what I saw in 1972 and what I saw in 2019 was like the difference between the rain forest in Puerto Rico and the dunes of the Sahara Desert.

Sure, I have heard David talk about the mental health effects of climate change on stress, anxiety, and depression, and I have always thought that he was right. But to see climate change up close and personal is a sobering experience. Lately, I have found myself apologizing to children I know. I apologize to them for being part of the system and process that is destroying the planet – and leaving them with a hot mess.

At this point, it seems to me that we cannot just try to save the planet by being better stewards of our garbage and pointing out measurable indicators of climate change. We need to actively rather than passively try to save the planet. Of course, the question is who will pay for the active efforts to depollute Earth. From what I saw for myself in Hanauma Bay, I don’t think we have much time. So I am hoping that more people will take the issue of climate change seriously.

Dr. Bell is a staff psychiatrist at Jackson Park Hospital’s Medical/Surgical-Psychiatry Inpatient Unit in Chicago, clinical psychiatrist emeritus in the department of psychiatry at the University of Illinois at Chicago, former president/CEO of Community Mental Health Council, and former director of the Institute for Juvenile Research (birthplace of child psychiatry), also in Chicago. Check out Dr. Bell’s new book, “Fetal Alcohol Exposure in the African-American Community,” at https://thirdworldpressfoundation.org/product/pre-order-fetal-alcohol-exposure-in-the-african-american-community/.
 

 

It used to be difficult to conceive of writing about climate change in light of the illnesses we psychiatrists treat. But talking about climate change has become unavoidable. Sometimes, it seems that things weigh heavy on my heart, and I have to write about them – especially when it is serious.

Dr. Carl C. Bell

David Alan Pollack, MD, has been talking about climate change for some years now, and while I understood his concern, I had yet to see the psychological effects up close and personal. After all, I live in Chicago, and we are surrounded by concrete and asphalt.

Thankfully, I also travel, and I get a chance to get into nature. While in Hawaii at the American College of Psychiatrists annual meeting in February, I went snorkeling in Hanauma Bay. I saw coral and fish. The problem is I have a very vivid memories of snorkeling in that exact same nature preserve, which also was a Marine Life Conservation District in 1972 while I was attending the American Psychiatric Association annual meeting.

The contrast between the two experiences leaves me with a glum, sad, disappointed, heart-broken feeling because it was an intimate and personal experience with climate change. In 1972, I saw every type of coral imaginable: brain coral, club finger coral, elk coral, great star coral, pillar coral, staghorn coral, table coral, and tube coral. If I remember correctly, there were corky sea fingers and sea fans, but not sea turtles. In 1972, I saw bigeyefish, damselfish, doctorfish, filefish, goatfish, gobies, hogfish, lemon butterflyfish, lizardfish, parrottfish, porcupinefish, pufferfish, queen angelfish, rock beauties, sergeant majors, soldierfish, spot-tail spot-tail butterflyfish, Spanish hogfish, squirrelfish, tangs, trunkfish, or any bluehead or yellowhead wrasses.



In 2019, I saw two pieces of coral less that 9 inches in diameter and not a single sea urchin. There were maybe three types of tropical fish that I was unfamiliar with seeing. The difference between what I saw in 1972 and what I saw in 2019 was like the difference between the rain forest in Puerto Rico and the dunes of the Sahara Desert.

Sure, I have heard David talk about the mental health effects of climate change on stress, anxiety, and depression, and I have always thought that he was right. But to see climate change up close and personal is a sobering experience. Lately, I have found myself apologizing to children I know. I apologize to them for being part of the system and process that is destroying the planet – and leaving them with a hot mess.

At this point, it seems to me that we cannot just try to save the planet by being better stewards of our garbage and pointing out measurable indicators of climate change. We need to actively rather than passively try to save the planet. Of course, the question is who will pay for the active efforts to depollute Earth. From what I saw for myself in Hanauma Bay, I don’t think we have much time. So I am hoping that more people will take the issue of climate change seriously.

Dr. Bell is a staff psychiatrist at Jackson Park Hospital’s Medical/Surgical-Psychiatry Inpatient Unit in Chicago, clinical psychiatrist emeritus in the department of psychiatry at the University of Illinois at Chicago, former president/CEO of Community Mental Health Council, and former director of the Institute for Juvenile Research (birthplace of child psychiatry), also in Chicago. Check out Dr. Bell’s new book, “Fetal Alcohol Exposure in the African-American Community,” at https://thirdworldpressfoundation.org/product/pre-order-fetal-alcohol-exposure-in-the-african-american-community/.
 

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A Vital Clue to the Problem

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The correct interpretation is a bit challenging. You’ve confirmed the electrodes were placed correctly; however, the P waves are unusual (best seen in lead II) and are suggestive of an ectopic atrial rhythm. In lead II, there are two P waves for each QRS complex, consistent with second-degree atrioventricular (AV) block with 2:1 AV conduction. The QRS complex is wide at 130 ms without a right or left bundle branch pattern, consistent with a nonspecific intraventricular conduction block, and there is evidence of nonspecific ST-T wave abnormality.

These changes were new compared with the patient’s preoperative ECG, which showed sinus rhythm and no evidence of heart block.

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ANSWER

The correct interpretation is a bit challenging. You’ve confirmed the electrodes were placed correctly; however, the P waves are unusual (best seen in lead II) and are suggestive of an ectopic atrial rhythm. In lead II, there are two P waves for each QRS complex, consistent with second-degree atrioventricular (AV) block with 2:1 AV conduction. The QRS complex is wide at 130 ms without a right or left bundle branch pattern, consistent with a nonspecific intraventricular conduction block, and there is evidence of nonspecific ST-T wave abnormality.

These changes were new compared with the patient’s preoperative ECG, which showed sinus rhythm and no evidence of heart block.

ANSWER

The correct interpretation is a bit challenging. You’ve confirmed the electrodes were placed correctly; however, the P waves are unusual (best seen in lead II) and are suggestive of an ectopic atrial rhythm. In lead II, there are two P waves for each QRS complex, consistent with second-degree atrioventricular (AV) block with 2:1 AV conduction. The QRS complex is wide at 130 ms without a right or left bundle branch pattern, consistent with a nonspecific intraventricular conduction block, and there is evidence of nonspecific ST-T wave abnormality.

These changes were new compared with the patient’s preoperative ECG, which showed sinus rhythm and no evidence of heart block.

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A Vital Clue to the Problem

Two days ago, a 76-year-old man underwent surgical repair of a left femoral fracture sustained in an automobile accident. Last night, his vital signs were concerning for asymptomatic bradycardia, prompting an order for ECG prior to morning rounds. His postoperative surgical course has been otherwise uneventful, and he is using minimal narcotic analgesia.

The patient has a long history of mild hypertension, which is well controlled with hydrochlorothiazide (50 mg/d). Otherwise, his medical history shows no angina, dyspnea, shortness of breath, or palpitations. There is no history of thyroid dysfunction or renal disease.

A pack-a-day smoker since age 15, the patient has been using a nicotine patch during his hospital stay. In the past 36 hours, he has taken 4 acetaminophen/oxycodone tablets (325/5 mg).

The patient works on a 400-acre ranch with about 100 head of cattle. His alcohol consumption was heavy until about 12 years ago, when he “blacked out” and gave up drinking altogether. He attends Alcoholics Anonymous meetings and leads sessions at his church. He denies recreational or illicit drug use.

Family history is positive for prostate cancer in his father and lung cancer in two brothers. His mother died of a hemorrhagic stroke at age 84.

The review of systems is remarkable only for discomfort due to an indwelling Foley catheter placed at the time of the surgery. He has no other specific complaints.

This morning, his vital signs include a blood pressure of 108/60 mm Hg; pulse, 42 beats/min; and O2 saturation, 100% on 2L of oxygen via nasal prongs.

When you arrive at the patient’s room, the ECG is in progress. The technician expresses concern about the tracing and shows you that the electrodes are placed properly. Looking at the ECG, you see a ventricular rate of 42 beats/min; PR interval, unmeasured; QRS duration, 130 ms; QT/QTc interval, 514/429 ms; P axis, +83°; R axis, +84°; and T axis, –43°. What is your interpretation?

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Hope for hyperhidrosis

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Hyperhidrosis – excessive sweating – is one of those diagnoses that make most physicians cringe because we know that the side effects of most of the common treatments are very limiting and patients continue to be frustrated. New treatments are emerging, and although oxybutynin is not Food and Drug Administration–approved for hyperhidrosis, it does show promise. 

Primary hyperhidrosis is the excessive sweating from the axilla, palms, soles, or cranial-facial area. It is a clinical diagnosis that has been occurring for more than 6 months and meets at least four1 of the following criteria:

1. It occurs in eccrine dense areas (axilla, soles, palms or head).

2. It is bilateral and symmetrical.

3. It is absent nocturnally.

4. Its onset should be before age 25 years.

5. It occurs at least weekly.

6. There is a positive family history.

7. It impairs daily activities.

If signs of underlying disease are apparent – such as palpitations, night sweats, weight loss, unilateral symptoms, anxiety, or hypertension – further workup is needed to rule out disorders such as diabetes, hyperthyroidism, pheochromocytoma, or peripheral nerve injury.1

The pathophysiology of hyperhidrosis is not clearly understood. It is believed to be due to increased cholinergic stimulation given that there is no hypertrophy or hyperplasia of the sweat gland.2 Genetics appear to play a role as there is usually a family history of the disorder.2

Topical treatments are usually first line, starting with aluminum chloride antiperspirants, or anticholinergic creams such as glycopyrrolate or glycopyrronium. Unfortunately, many patients complain of the skin irritation so they discontinue their use.1

Botulinum toxin type A is a very safe and effective way of treating hyperhidrosis and is FDA approved for that purpose.3 Its drawbacks are that it is an injection (approximately 25 in each armpit), and it is very costly, usually $1,000-1,500 per session for both underarms. There are no major side effects, and reduction in sweating lasts for 4-12 months, with a median of 6 months.3

Oral treatment of hyperhidrosis, with medications such as glycopyrrolate and benztropine, has been reserved for second- or third-line treatment because of the unwanted side effects of dry mouth and drowsiness. But more recent studies are showing favorable outcomes with oxybutynin.1

Oxybutynin is well known and FDA approved for treatment of urinary frequency, incontinence, and enuresis. Recent studies have shown great success for use to control generalized hyperhidrosis. The mechanism of action is blocking the binding of acetylcholine and numerous other neurotransmitters.2

The literature does not give clear-cut dosing because it is not approved for hyperhidrosis, but gradually increasing doses starting at 2.5 mg daily for a week, then increasing to twice daily for 2 weeks, and then to 5 mg twice daily as a continued dose appears to be the most effective regimen with few side effects. The dosage can be increased, but increased side effects are noted with doses reaching 15 mg/day.1,2

Dr. Francine Pearce

Oxybutynin is not FDA approved for the treatment of hyperhidrosis, but it is an inexpensive drug, which makes it a viable option for use off label given all of the current research with positive outcomes.

It should be noted that if patients have any urinary retention, gastric motility issues, or narrow angle glaucoma, oxybutynin is contraindicated.

More studies are on the horizon, but finally there is hope for hyperhidrosis.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. Skin Appendage Disord. 2015 Mar;1(1):6-13.

2. An Bras Dermatol. 2017 Mar-Apr;92(2):217-20.

3. ISRN Dermatol. 2012. doi: 10.5402/2012/702714.

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Hyperhidrosis – excessive sweating – is one of those diagnoses that make most physicians cringe because we know that the side effects of most of the common treatments are very limiting and patients continue to be frustrated. New treatments are emerging, and although oxybutynin is not Food and Drug Administration–approved for hyperhidrosis, it does show promise. 

Primary hyperhidrosis is the excessive sweating from the axilla, palms, soles, or cranial-facial area. It is a clinical diagnosis that has been occurring for more than 6 months and meets at least four1 of the following criteria:

1. It occurs in eccrine dense areas (axilla, soles, palms or head).

2. It is bilateral and symmetrical.

3. It is absent nocturnally.

4. Its onset should be before age 25 years.

5. It occurs at least weekly.

6. There is a positive family history.

7. It impairs daily activities.

If signs of underlying disease are apparent – such as palpitations, night sweats, weight loss, unilateral symptoms, anxiety, or hypertension – further workup is needed to rule out disorders such as diabetes, hyperthyroidism, pheochromocytoma, or peripheral nerve injury.1

The pathophysiology of hyperhidrosis is not clearly understood. It is believed to be due to increased cholinergic stimulation given that there is no hypertrophy or hyperplasia of the sweat gland.2 Genetics appear to play a role as there is usually a family history of the disorder.2

Topical treatments are usually first line, starting with aluminum chloride antiperspirants, or anticholinergic creams such as glycopyrrolate or glycopyrronium. Unfortunately, many patients complain of the skin irritation so they discontinue their use.1

Botulinum toxin type A is a very safe and effective way of treating hyperhidrosis and is FDA approved for that purpose.3 Its drawbacks are that it is an injection (approximately 25 in each armpit), and it is very costly, usually $1,000-1,500 per session for both underarms. There are no major side effects, and reduction in sweating lasts for 4-12 months, with a median of 6 months.3

Oral treatment of hyperhidrosis, with medications such as glycopyrrolate and benztropine, has been reserved for second- or third-line treatment because of the unwanted side effects of dry mouth and drowsiness. But more recent studies are showing favorable outcomes with oxybutynin.1

Oxybutynin is well known and FDA approved for treatment of urinary frequency, incontinence, and enuresis. Recent studies have shown great success for use to control generalized hyperhidrosis. The mechanism of action is blocking the binding of acetylcholine and numerous other neurotransmitters.2

The literature does not give clear-cut dosing because it is not approved for hyperhidrosis, but gradually increasing doses starting at 2.5 mg daily for a week, then increasing to twice daily for 2 weeks, and then to 5 mg twice daily as a continued dose appears to be the most effective regimen with few side effects. The dosage can be increased, but increased side effects are noted with doses reaching 15 mg/day.1,2

Dr. Francine Pearce

Oxybutynin is not FDA approved for the treatment of hyperhidrosis, but it is an inexpensive drug, which makes it a viable option for use off label given all of the current research with positive outcomes.

It should be noted that if patients have any urinary retention, gastric motility issues, or narrow angle glaucoma, oxybutynin is contraindicated.

More studies are on the horizon, but finally there is hope for hyperhidrosis.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. Skin Appendage Disord. 2015 Mar;1(1):6-13.

2. An Bras Dermatol. 2017 Mar-Apr;92(2):217-20.

3. ISRN Dermatol. 2012. doi: 10.5402/2012/702714.

 

Hyperhidrosis – excessive sweating – is one of those diagnoses that make most physicians cringe because we know that the side effects of most of the common treatments are very limiting and patients continue to be frustrated. New treatments are emerging, and although oxybutynin is not Food and Drug Administration–approved for hyperhidrosis, it does show promise. 

Primary hyperhidrosis is the excessive sweating from the axilla, palms, soles, or cranial-facial area. It is a clinical diagnosis that has been occurring for more than 6 months and meets at least four1 of the following criteria:

1. It occurs in eccrine dense areas (axilla, soles, palms or head).

2. It is bilateral and symmetrical.

3. It is absent nocturnally.

4. Its onset should be before age 25 years.

5. It occurs at least weekly.

6. There is a positive family history.

7. It impairs daily activities.

If signs of underlying disease are apparent – such as palpitations, night sweats, weight loss, unilateral symptoms, anxiety, or hypertension – further workup is needed to rule out disorders such as diabetes, hyperthyroidism, pheochromocytoma, or peripheral nerve injury.1

The pathophysiology of hyperhidrosis is not clearly understood. It is believed to be due to increased cholinergic stimulation given that there is no hypertrophy or hyperplasia of the sweat gland.2 Genetics appear to play a role as there is usually a family history of the disorder.2

Topical treatments are usually first line, starting with aluminum chloride antiperspirants, or anticholinergic creams such as glycopyrrolate or glycopyrronium. Unfortunately, many patients complain of the skin irritation so they discontinue their use.1

Botulinum toxin type A is a very safe and effective way of treating hyperhidrosis and is FDA approved for that purpose.3 Its drawbacks are that it is an injection (approximately 25 in each armpit), and it is very costly, usually $1,000-1,500 per session for both underarms. There are no major side effects, and reduction in sweating lasts for 4-12 months, with a median of 6 months.3

Oral treatment of hyperhidrosis, with medications such as glycopyrrolate and benztropine, has been reserved for second- or third-line treatment because of the unwanted side effects of dry mouth and drowsiness. But more recent studies are showing favorable outcomes with oxybutynin.1

Oxybutynin is well known and FDA approved for treatment of urinary frequency, incontinence, and enuresis. Recent studies have shown great success for use to control generalized hyperhidrosis. The mechanism of action is blocking the binding of acetylcholine and numerous other neurotransmitters.2

The literature does not give clear-cut dosing because it is not approved for hyperhidrosis, but gradually increasing doses starting at 2.5 mg daily for a week, then increasing to twice daily for 2 weeks, and then to 5 mg twice daily as a continued dose appears to be the most effective regimen with few side effects. The dosage can be increased, but increased side effects are noted with doses reaching 15 mg/day.1,2

Dr. Francine Pearce

Oxybutynin is not FDA approved for the treatment of hyperhidrosis, but it is an inexpensive drug, which makes it a viable option for use off label given all of the current research with positive outcomes.

It should be noted that if patients have any urinary retention, gastric motility issues, or narrow angle glaucoma, oxybutynin is contraindicated.

More studies are on the horizon, but finally there is hope for hyperhidrosis.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. Skin Appendage Disord. 2015 Mar;1(1):6-13.

2. An Bras Dermatol. 2017 Mar-Apr;92(2):217-20.

3. ISRN Dermatol. 2012. doi: 10.5402/2012/702714.

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Clinical trials unavailable for more than half of all cancer patients

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Thu, 03/28/2019 - 14:29

 

More than half of all cancer patients do not participate in clinical trials because none are available for their cancer type or stage at their institution, according to a meta-analysis of cancer clinical trials that examined the trial decision-making pathway.

“This is the first effort to systematically both define and quantify domains of clinical trial barriers using a meta-analytic approach,” wrote lead author Joseph M. Unger, PhD, of the Fred Hutchinson Cancer Research Center in Seattle and his coauthors in the Journal of the National Cancer Institute.

To identify trials that addressed barriers to enrollment, Dr. Unger and his colleagues conducted a literature search using the PubMed, Google Scholar, Web of Science, and Ovid Medline databases. The search returned 7,576 unique results, of which they reviewed 38 full articles and eventually decided on 13 studies comprising 8,883 patients. Nine of the studies were focused on academic care settings, and four were focused on community care settings; seven examined patient decision-making patterns in all types of cancers, while the others focused on breast cancer only (n = 2), lung cancer only (n = 2), prostate cancer only (n = 1), and cervix/uterine cancers (n = 1).

Their analysis found that, for 55.6% of patients, no trial was available for their cancer type and stage (95% confidence interval, 43.7%-67.3%). In addition, 21.5% (95% CI, 10.9%-34.6%) were not eligible for an available trial, and 14.8% (95% CI, 9.0%-21.7%) did not enroll; only 8.1% (95% CI, 6.3%-10.0%) enrolled in a trial. Academic sites (15.9%, 95% CI, 13.8%-18.2%) saw much higher rates of participation than community sites (7.0%, 95% CI, 5.1%-9.1%; P less than .001).

The authors acknowledged their study’s limitations, including details on trial availability not being available for all analyzed studies. In addition, several of the studies relied on selected cancer types instead of sampling a representative set of cancers. Finally, these studies may have oversampled research-oriented sites, which would mean “the actual overall trial participation rate may be lower than we estimated.”

The study was supported by the National Cancer Institute. The authors reported no conflicts of interest.

SOURCE: Unger JM et al. J Natl Cancer Inst. 2019 Feb 19. doi: 10.1093/jnci/djy221.

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More than half of all cancer patients do not participate in clinical trials because none are available for their cancer type or stage at their institution, according to a meta-analysis of cancer clinical trials that examined the trial decision-making pathway.

“This is the first effort to systematically both define and quantify domains of clinical trial barriers using a meta-analytic approach,” wrote lead author Joseph M. Unger, PhD, of the Fred Hutchinson Cancer Research Center in Seattle and his coauthors in the Journal of the National Cancer Institute.

To identify trials that addressed barriers to enrollment, Dr. Unger and his colleagues conducted a literature search using the PubMed, Google Scholar, Web of Science, and Ovid Medline databases. The search returned 7,576 unique results, of which they reviewed 38 full articles and eventually decided on 13 studies comprising 8,883 patients. Nine of the studies were focused on academic care settings, and four were focused on community care settings; seven examined patient decision-making patterns in all types of cancers, while the others focused on breast cancer only (n = 2), lung cancer only (n = 2), prostate cancer only (n = 1), and cervix/uterine cancers (n = 1).

Their analysis found that, for 55.6% of patients, no trial was available for their cancer type and stage (95% confidence interval, 43.7%-67.3%). In addition, 21.5% (95% CI, 10.9%-34.6%) were not eligible for an available trial, and 14.8% (95% CI, 9.0%-21.7%) did not enroll; only 8.1% (95% CI, 6.3%-10.0%) enrolled in a trial. Academic sites (15.9%, 95% CI, 13.8%-18.2%) saw much higher rates of participation than community sites (7.0%, 95% CI, 5.1%-9.1%; P less than .001).

The authors acknowledged their study’s limitations, including details on trial availability not being available for all analyzed studies. In addition, several of the studies relied on selected cancer types instead of sampling a representative set of cancers. Finally, these studies may have oversampled research-oriented sites, which would mean “the actual overall trial participation rate may be lower than we estimated.”

The study was supported by the National Cancer Institute. The authors reported no conflicts of interest.

SOURCE: Unger JM et al. J Natl Cancer Inst. 2019 Feb 19. doi: 10.1093/jnci/djy221.

 

More than half of all cancer patients do not participate in clinical trials because none are available for their cancer type or stage at their institution, according to a meta-analysis of cancer clinical trials that examined the trial decision-making pathway.

“This is the first effort to systematically both define and quantify domains of clinical trial barriers using a meta-analytic approach,” wrote lead author Joseph M. Unger, PhD, of the Fred Hutchinson Cancer Research Center in Seattle and his coauthors in the Journal of the National Cancer Institute.

To identify trials that addressed barriers to enrollment, Dr. Unger and his colleagues conducted a literature search using the PubMed, Google Scholar, Web of Science, and Ovid Medline databases. The search returned 7,576 unique results, of which they reviewed 38 full articles and eventually decided on 13 studies comprising 8,883 patients. Nine of the studies were focused on academic care settings, and four were focused on community care settings; seven examined patient decision-making patterns in all types of cancers, while the others focused on breast cancer only (n = 2), lung cancer only (n = 2), prostate cancer only (n = 1), and cervix/uterine cancers (n = 1).

Their analysis found that, for 55.6% of patients, no trial was available for their cancer type and stage (95% confidence interval, 43.7%-67.3%). In addition, 21.5% (95% CI, 10.9%-34.6%) were not eligible for an available trial, and 14.8% (95% CI, 9.0%-21.7%) did not enroll; only 8.1% (95% CI, 6.3%-10.0%) enrolled in a trial. Academic sites (15.9%, 95% CI, 13.8%-18.2%) saw much higher rates of participation than community sites (7.0%, 95% CI, 5.1%-9.1%; P less than .001).

The authors acknowledged their study’s limitations, including details on trial availability not being available for all analyzed studies. In addition, several of the studies relied on selected cancer types instead of sampling a representative set of cancers. Finally, these studies may have oversampled research-oriented sites, which would mean “the actual overall trial participation rate may be lower than we estimated.”

The study was supported by the National Cancer Institute. The authors reported no conflicts of interest.

SOURCE: Unger JM et al. J Natl Cancer Inst. 2019 Feb 19. doi: 10.1093/jnci/djy221.

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FROM THE JOURNAL OF THE NATIONAL CANCER INSTITUTE

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‘The birth of a mother is a complex process’

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Thu, 03/14/2019 - 11:26

Softening the blow to women and families of severe perinatal, postpartum psychiatric disorders

Editor’s Note: Alison M. Heru, MD, the Families in Psychiatry columnist, invited Dr. Reinstein to address this topic.

“But this was not what I expected!” That’s a statement I have heard from countless new mothers.

KatarzynaBialasiewicz/Thinkstock

Women often envision pregnancy and the postpartum period as a time of pure joy. The glow of an expectant woman and the excitement of the arrival of a new baby masks the reality that many women struggle emotionally when transitioning to motherhood. Like the birth of a child, the birth of a mother is a complex process. Upholding the myth that all women seamlessly transform into mothers can have devastating effects and hinder access to mental health care.

As a psychiatrist working on a women’s inpatient unit with a perinatal program, I treat women at times of crisis. What may have begun as mild anxiety or depression sometimes quickly spirals into severe psychiatric illness. The sheer force of these severe perinatal and postpartum psychiatric disorders often leaves women and families shocked and confused, wondering what happened to their crumbled dreams of early motherhood.

What must general psychiatrists know about perinatal and postpartum psychiatric disorders? Why is maternal mental health so important? What are the barriers to treatment for these women? How can general psychiatrists best support and treat these new mothers and their families?

What data show

Maternal depression is now known to be one of the most common complications of pregnancy. Studies have suggested that about 11% of women experience depression during pregnancy1 and approximately 17% of women are depressed in the postpartum period.2 Perinatal generalized anxiety disorder has been shown to have a prevalence of 8.5%-10.5% during pregnancy with a wider variance post partum.3 Approximately 3% of women in the general community develop PTSD symptoms following childbirth.4 Research suggests that about 2% of women develop obsessive-compulsive disorder symptoms in the postpartum period.5 Postpartum psychosis, a rare but potentially devastating illness, occurs after 0.1%-0.2% of births.6

Importance of maternal mental health

There is a growing body of literature supporting both obstetric and pediatric adverse outcomes related to untreated psychiatric illness. Untreated maternal depression has been associated with obstetric complications, such as preterm delivery, preeclampsia, low birth weight, as well as the child’s developing cognitive function.7 Anxiety during pregnancy has been associated with both a shorter gestational period and adverse implications for fetal neurodevelopment.

Dr. Sarah Reinstein

These adverse effects were found to be even more potent in “pregnancy anxiety,” or anxiety specifically focused on the pregnancy, the birth experience, and the transition to motherhood.8 The psychotic symptoms occurring during postpartum psychosis can jeopardize the lives of both a woman and her child and carries a 4% risk of infanticide.9 Although there are limited data about the long-term effects of postpartum obsessive-compulsive disorders and PTSD, it is reasonable to assume that they might carry negative long-term implications for the mother and possibly her child.

 

 

Barriers to treatment

Despite the significant rates of mental illness, pregnant and new mothers often face barriers to receiving treatment. Many psychiatrists are hesitant to prescribe psychiatric medication to pregnant women because of concerns about teratogenic potential of psychiatric medications; similar concerns exist for newborn babies when prescribing medications to lactating mothers. In addition, the field of reproductive psychiatry is evolving at a rapid pace, making it difficult for busy psychiatrists to keep up with the ever-growing literature.

Also, it is hard to imagine a population that has more barriers to attending outpatient appointments. For many new mothers, the exhaustion and all-consuming work involved with taking care of a newborn are insurmountable barriers to obtaining mental health care. In addition, despite the awareness that new mothers often are more emotional, families can be slow to recognize the developing severity of a psychiatric illness during the peripartum and postpartum periods.

Supporting and treating new mothers

As general psychiatrists, there are several ways to directly help these women.

1. Expect the expected. Even in women with no prior psychiatric history, a significant percentage of expectant and postpartum women will develop acute psychiatric symptoms. Learn about the different presentations and treatments of perinatal and postpartum psychiatric disorders. For example, a woman might have thoughts of harming her baby in both postpartum psychosis and obsessive-compulsive disorder. However, the acuity and treatment of these two conditions drastically differ.

2. Learn more about psychiatric medications. Several apps and websites are available to psychiatrists to learn about the safety profile of psychiatric medications, such as Reprotox.org, mothertobaby.org, lactmed, and womensmentalhealth.org. Many medications are considered to be relatively safe during pregnancy and breastfeeding. It is important for psychiatrists to appreciate the risks when choosing not to prescribe to pregnant and postpartum women. Sometimes a known risk of a specific medication may be preferable to the unknown risk of leaving a woman susceptible to a severe psychiatric decompensation.

3. Involve all members of the family. A mother’s mental health has significant implications for the entire family. Psychoeducation for the family as well as frequent family sessions are key tools when treating this population. In addition, prescribing to pregnant women provides the opportunity for a psychiatrist to refine skills in joint decision making; it is crucial to involve both a patient and her spouse when discussing psychiatric medications.

4. Provide ready access and collaborate care. It is important to understand the potential rapid onset of psychiatric symptoms during the pregnancy and postpartum period. Expectant and postpartum women should be granted priority for scheduling appointments with expedited appointments when possible. Psychiatrists should be prepared to collaborate care with other specialties. It is important to establish relationships with community psychotherapists specializing in maternal mental health, pediatricians, as well as obstetricians.

5. Learn when to seek a higher level of care. Although many women with perinatal and postpartum psychiatric symptoms can be managed as outpatients, women at times need a higher level of care. Similar to general psychiatry, women who are acutely suicidal or homicidal or have a sudden onset of psychotic and manic symptoms all should be evaluated immediately for inpatient hospitalization. Women with less severe symptoms but who require a higher level of care than typically offered in standard outpatient treatment should be candidates for partial hospitalization programs.

 

 

General intensive programs usually can accommodate these women, but it is ideal to refer this population to perinatal intensive programs. Postpartum Support International (postpartum.net) lists the nationwide inpatient and partial perinatal programs as well as regional and local services. An example of inpatient perinatal care is the women’s unit at Zucker Hillside Hospital (Northwell Health System, Glen Oaks, N.Y.), which houses an inpatient perinatal program. As a psychiatrist on the unit, I treat acute symptoms such as depression, anxiety, psychosis, mania, and catatonia that occur during the perinatal and postpartum periods. Given the severity of symptoms, I use a wide range of psychiatric medications with the possibility of electroconvulsive therapy when indicated. Psychotherapy staff on the unit offer specialized perinatal, mothers, and dialectical behavioral therapy groups. Breast pumps are available for women who wish to breastfeed. Accommodations are made for babies and children to visit their mother when clinically appropriate. Once discharged, women often are referred to Zucker Hillside’s own perinatal outpatient clinic for continued treatment. Similar models exist in select inpatient units as well as an increasing number of partial programs across the United States.

Conclusion

Psychiatric care for pregnant and new mothers can be challenging, but it is also immensely rewarding. Restoring a mother’s mental health usually leads to increased emotional stability for her entire family. Given the prevalence of maternal mental health disorders, psychiatrists in nearly every setting will encounter this population of women. With dedicated time devoted to reviewing the literature and learning about local resources, psychiatrists can feel comfortable treating women throughout the childbearing experience.

References

1. J Affect Disord. 2017 Sep;219:86-92.

2. J Psychiatr Res. 2018 Sep;104:235-48.

3. J Womens Health. (Larchmt). 2015 Sep;24(9):762-70.

4. Clin Psychol Rev. 2014 Jul;34(5):389-401.

5. Compr Psychiatry. 2009 Nov-Dec;50(6):503-9.

6. Int Rev Psychiatry. 2003 Aug;15(3):231-42.

7. Clin Obstet Gynecol. 2018 Sep;61(3):533-43.

8. Curr Opinion Psychiatry. 2012 Mar;25(2):141-8.

9. Am J Psychiatry. 2009 Apr;166(4):405-8.

Dr. Reinstein is a psychiatry attending at Zucker Hillside Hospital. Her clinical interests include reproductive psychiatry and family therapy, with a specific focus on maternal mental health. Dr. Reinstein completed her adult psychiatry residency training at Montefiore Hospital/Albert Einstein College of Medicine, New York, after graduating from the Albert Einstein College of Medicine and Yeshiva University, New York, with a BA in biology. She is one of the recipients of the 4th Annual Resident Recognition Award for Excellence in Family Oriented Care.

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Softening the blow to women and families of severe perinatal, postpartum psychiatric disorders

Softening the blow to women and families of severe perinatal, postpartum psychiatric disorders

Editor’s Note: Alison M. Heru, MD, the Families in Psychiatry columnist, invited Dr. Reinstein to address this topic.

“But this was not what I expected!” That’s a statement I have heard from countless new mothers.

KatarzynaBialasiewicz/Thinkstock

Women often envision pregnancy and the postpartum period as a time of pure joy. The glow of an expectant woman and the excitement of the arrival of a new baby masks the reality that many women struggle emotionally when transitioning to motherhood. Like the birth of a child, the birth of a mother is a complex process. Upholding the myth that all women seamlessly transform into mothers can have devastating effects and hinder access to mental health care.

As a psychiatrist working on a women’s inpatient unit with a perinatal program, I treat women at times of crisis. What may have begun as mild anxiety or depression sometimes quickly spirals into severe psychiatric illness. The sheer force of these severe perinatal and postpartum psychiatric disorders often leaves women and families shocked and confused, wondering what happened to their crumbled dreams of early motherhood.

What must general psychiatrists know about perinatal and postpartum psychiatric disorders? Why is maternal mental health so important? What are the barriers to treatment for these women? How can general psychiatrists best support and treat these new mothers and their families?

What data show

Maternal depression is now known to be one of the most common complications of pregnancy. Studies have suggested that about 11% of women experience depression during pregnancy1 and approximately 17% of women are depressed in the postpartum period.2 Perinatal generalized anxiety disorder has been shown to have a prevalence of 8.5%-10.5% during pregnancy with a wider variance post partum.3 Approximately 3% of women in the general community develop PTSD symptoms following childbirth.4 Research suggests that about 2% of women develop obsessive-compulsive disorder symptoms in the postpartum period.5 Postpartum psychosis, a rare but potentially devastating illness, occurs after 0.1%-0.2% of births.6

Importance of maternal mental health

There is a growing body of literature supporting both obstetric and pediatric adverse outcomes related to untreated psychiatric illness. Untreated maternal depression has been associated with obstetric complications, such as preterm delivery, preeclampsia, low birth weight, as well as the child’s developing cognitive function.7 Anxiety during pregnancy has been associated with both a shorter gestational period and adverse implications for fetal neurodevelopment.

Dr. Sarah Reinstein

These adverse effects were found to be even more potent in “pregnancy anxiety,” or anxiety specifically focused on the pregnancy, the birth experience, and the transition to motherhood.8 The psychotic symptoms occurring during postpartum psychosis can jeopardize the lives of both a woman and her child and carries a 4% risk of infanticide.9 Although there are limited data about the long-term effects of postpartum obsessive-compulsive disorders and PTSD, it is reasonable to assume that they might carry negative long-term implications for the mother and possibly her child.

 

 

Barriers to treatment

Despite the significant rates of mental illness, pregnant and new mothers often face barriers to receiving treatment. Many psychiatrists are hesitant to prescribe psychiatric medication to pregnant women because of concerns about teratogenic potential of psychiatric medications; similar concerns exist for newborn babies when prescribing medications to lactating mothers. In addition, the field of reproductive psychiatry is evolving at a rapid pace, making it difficult for busy psychiatrists to keep up with the ever-growing literature.

Also, it is hard to imagine a population that has more barriers to attending outpatient appointments. For many new mothers, the exhaustion and all-consuming work involved with taking care of a newborn are insurmountable barriers to obtaining mental health care. In addition, despite the awareness that new mothers often are more emotional, families can be slow to recognize the developing severity of a psychiatric illness during the peripartum and postpartum periods.

Supporting and treating new mothers

As general psychiatrists, there are several ways to directly help these women.

1. Expect the expected. Even in women with no prior psychiatric history, a significant percentage of expectant and postpartum women will develop acute psychiatric symptoms. Learn about the different presentations and treatments of perinatal and postpartum psychiatric disorders. For example, a woman might have thoughts of harming her baby in both postpartum psychosis and obsessive-compulsive disorder. However, the acuity and treatment of these two conditions drastically differ.

2. Learn more about psychiatric medications. Several apps and websites are available to psychiatrists to learn about the safety profile of psychiatric medications, such as Reprotox.org, mothertobaby.org, lactmed, and womensmentalhealth.org. Many medications are considered to be relatively safe during pregnancy and breastfeeding. It is important for psychiatrists to appreciate the risks when choosing not to prescribe to pregnant and postpartum women. Sometimes a known risk of a specific medication may be preferable to the unknown risk of leaving a woman susceptible to a severe psychiatric decompensation.

3. Involve all members of the family. A mother’s mental health has significant implications for the entire family. Psychoeducation for the family as well as frequent family sessions are key tools when treating this population. In addition, prescribing to pregnant women provides the opportunity for a psychiatrist to refine skills in joint decision making; it is crucial to involve both a patient and her spouse when discussing psychiatric medications.

4. Provide ready access and collaborate care. It is important to understand the potential rapid onset of psychiatric symptoms during the pregnancy and postpartum period. Expectant and postpartum women should be granted priority for scheduling appointments with expedited appointments when possible. Psychiatrists should be prepared to collaborate care with other specialties. It is important to establish relationships with community psychotherapists specializing in maternal mental health, pediatricians, as well as obstetricians.

5. Learn when to seek a higher level of care. Although many women with perinatal and postpartum psychiatric symptoms can be managed as outpatients, women at times need a higher level of care. Similar to general psychiatry, women who are acutely suicidal or homicidal or have a sudden onset of psychotic and manic symptoms all should be evaluated immediately for inpatient hospitalization. Women with less severe symptoms but who require a higher level of care than typically offered in standard outpatient treatment should be candidates for partial hospitalization programs.

 

 

General intensive programs usually can accommodate these women, but it is ideal to refer this population to perinatal intensive programs. Postpartum Support International (postpartum.net) lists the nationwide inpatient and partial perinatal programs as well as regional and local services. An example of inpatient perinatal care is the women’s unit at Zucker Hillside Hospital (Northwell Health System, Glen Oaks, N.Y.), which houses an inpatient perinatal program. As a psychiatrist on the unit, I treat acute symptoms such as depression, anxiety, psychosis, mania, and catatonia that occur during the perinatal and postpartum periods. Given the severity of symptoms, I use a wide range of psychiatric medications with the possibility of electroconvulsive therapy when indicated. Psychotherapy staff on the unit offer specialized perinatal, mothers, and dialectical behavioral therapy groups. Breast pumps are available for women who wish to breastfeed. Accommodations are made for babies and children to visit their mother when clinically appropriate. Once discharged, women often are referred to Zucker Hillside’s own perinatal outpatient clinic for continued treatment. Similar models exist in select inpatient units as well as an increasing number of partial programs across the United States.

Conclusion

Psychiatric care for pregnant and new mothers can be challenging, but it is also immensely rewarding. Restoring a mother’s mental health usually leads to increased emotional stability for her entire family. Given the prevalence of maternal mental health disorders, psychiatrists in nearly every setting will encounter this population of women. With dedicated time devoted to reviewing the literature and learning about local resources, psychiatrists can feel comfortable treating women throughout the childbearing experience.

References

1. J Affect Disord. 2017 Sep;219:86-92.

2. J Psychiatr Res. 2018 Sep;104:235-48.

3. J Womens Health. (Larchmt). 2015 Sep;24(9):762-70.

4. Clin Psychol Rev. 2014 Jul;34(5):389-401.

5. Compr Psychiatry. 2009 Nov-Dec;50(6):503-9.

6. Int Rev Psychiatry. 2003 Aug;15(3):231-42.

7. Clin Obstet Gynecol. 2018 Sep;61(3):533-43.

8. Curr Opinion Psychiatry. 2012 Mar;25(2):141-8.

9. Am J Psychiatry. 2009 Apr;166(4):405-8.

Dr. Reinstein is a psychiatry attending at Zucker Hillside Hospital. Her clinical interests include reproductive psychiatry and family therapy, with a specific focus on maternal mental health. Dr. Reinstein completed her adult psychiatry residency training at Montefiore Hospital/Albert Einstein College of Medicine, New York, after graduating from the Albert Einstein College of Medicine and Yeshiva University, New York, with a BA in biology. She is one of the recipients of the 4th Annual Resident Recognition Award for Excellence in Family Oriented Care.

Editor’s Note: Alison M. Heru, MD, the Families in Psychiatry columnist, invited Dr. Reinstein to address this topic.

“But this was not what I expected!” That’s a statement I have heard from countless new mothers.

KatarzynaBialasiewicz/Thinkstock

Women often envision pregnancy and the postpartum period as a time of pure joy. The glow of an expectant woman and the excitement of the arrival of a new baby masks the reality that many women struggle emotionally when transitioning to motherhood. Like the birth of a child, the birth of a mother is a complex process. Upholding the myth that all women seamlessly transform into mothers can have devastating effects and hinder access to mental health care.

As a psychiatrist working on a women’s inpatient unit with a perinatal program, I treat women at times of crisis. What may have begun as mild anxiety or depression sometimes quickly spirals into severe psychiatric illness. The sheer force of these severe perinatal and postpartum psychiatric disorders often leaves women and families shocked and confused, wondering what happened to their crumbled dreams of early motherhood.

What must general psychiatrists know about perinatal and postpartum psychiatric disorders? Why is maternal mental health so important? What are the barriers to treatment for these women? How can general psychiatrists best support and treat these new mothers and their families?

What data show

Maternal depression is now known to be one of the most common complications of pregnancy. Studies have suggested that about 11% of women experience depression during pregnancy1 and approximately 17% of women are depressed in the postpartum period.2 Perinatal generalized anxiety disorder has been shown to have a prevalence of 8.5%-10.5% during pregnancy with a wider variance post partum.3 Approximately 3% of women in the general community develop PTSD symptoms following childbirth.4 Research suggests that about 2% of women develop obsessive-compulsive disorder symptoms in the postpartum period.5 Postpartum psychosis, a rare but potentially devastating illness, occurs after 0.1%-0.2% of births.6

Importance of maternal mental health

There is a growing body of literature supporting both obstetric and pediatric adverse outcomes related to untreated psychiatric illness. Untreated maternal depression has been associated with obstetric complications, such as preterm delivery, preeclampsia, low birth weight, as well as the child’s developing cognitive function.7 Anxiety during pregnancy has been associated with both a shorter gestational period and adverse implications for fetal neurodevelopment.

Dr. Sarah Reinstein

These adverse effects were found to be even more potent in “pregnancy anxiety,” or anxiety specifically focused on the pregnancy, the birth experience, and the transition to motherhood.8 The psychotic symptoms occurring during postpartum psychosis can jeopardize the lives of both a woman and her child and carries a 4% risk of infanticide.9 Although there are limited data about the long-term effects of postpartum obsessive-compulsive disorders and PTSD, it is reasonable to assume that they might carry negative long-term implications for the mother and possibly her child.

 

 

Barriers to treatment

Despite the significant rates of mental illness, pregnant and new mothers often face barriers to receiving treatment. Many psychiatrists are hesitant to prescribe psychiatric medication to pregnant women because of concerns about teratogenic potential of psychiatric medications; similar concerns exist for newborn babies when prescribing medications to lactating mothers. In addition, the field of reproductive psychiatry is evolving at a rapid pace, making it difficult for busy psychiatrists to keep up with the ever-growing literature.

Also, it is hard to imagine a population that has more barriers to attending outpatient appointments. For many new mothers, the exhaustion and all-consuming work involved with taking care of a newborn are insurmountable barriers to obtaining mental health care. In addition, despite the awareness that new mothers often are more emotional, families can be slow to recognize the developing severity of a psychiatric illness during the peripartum and postpartum periods.

Supporting and treating new mothers

As general psychiatrists, there are several ways to directly help these women.

1. Expect the expected. Even in women with no prior psychiatric history, a significant percentage of expectant and postpartum women will develop acute psychiatric symptoms. Learn about the different presentations and treatments of perinatal and postpartum psychiatric disorders. For example, a woman might have thoughts of harming her baby in both postpartum psychosis and obsessive-compulsive disorder. However, the acuity and treatment of these two conditions drastically differ.

2. Learn more about psychiatric medications. Several apps and websites are available to psychiatrists to learn about the safety profile of psychiatric medications, such as Reprotox.org, mothertobaby.org, lactmed, and womensmentalhealth.org. Many medications are considered to be relatively safe during pregnancy and breastfeeding. It is important for psychiatrists to appreciate the risks when choosing not to prescribe to pregnant and postpartum women. Sometimes a known risk of a specific medication may be preferable to the unknown risk of leaving a woman susceptible to a severe psychiatric decompensation.

3. Involve all members of the family. A mother’s mental health has significant implications for the entire family. Psychoeducation for the family as well as frequent family sessions are key tools when treating this population. In addition, prescribing to pregnant women provides the opportunity for a psychiatrist to refine skills in joint decision making; it is crucial to involve both a patient and her spouse when discussing psychiatric medications.

4. Provide ready access and collaborate care. It is important to understand the potential rapid onset of psychiatric symptoms during the pregnancy and postpartum period. Expectant and postpartum women should be granted priority for scheduling appointments with expedited appointments when possible. Psychiatrists should be prepared to collaborate care with other specialties. It is important to establish relationships with community psychotherapists specializing in maternal mental health, pediatricians, as well as obstetricians.

5. Learn when to seek a higher level of care. Although many women with perinatal and postpartum psychiatric symptoms can be managed as outpatients, women at times need a higher level of care. Similar to general psychiatry, women who are acutely suicidal or homicidal or have a sudden onset of psychotic and manic symptoms all should be evaluated immediately for inpatient hospitalization. Women with less severe symptoms but who require a higher level of care than typically offered in standard outpatient treatment should be candidates for partial hospitalization programs.

 

 

General intensive programs usually can accommodate these women, but it is ideal to refer this population to perinatal intensive programs. Postpartum Support International (postpartum.net) lists the nationwide inpatient and partial perinatal programs as well as regional and local services. An example of inpatient perinatal care is the women’s unit at Zucker Hillside Hospital (Northwell Health System, Glen Oaks, N.Y.), which houses an inpatient perinatal program. As a psychiatrist on the unit, I treat acute symptoms such as depression, anxiety, psychosis, mania, and catatonia that occur during the perinatal and postpartum periods. Given the severity of symptoms, I use a wide range of psychiatric medications with the possibility of electroconvulsive therapy when indicated. Psychotherapy staff on the unit offer specialized perinatal, mothers, and dialectical behavioral therapy groups. Breast pumps are available for women who wish to breastfeed. Accommodations are made for babies and children to visit their mother when clinically appropriate. Once discharged, women often are referred to Zucker Hillside’s own perinatal outpatient clinic for continued treatment. Similar models exist in select inpatient units as well as an increasing number of partial programs across the United States.

Conclusion

Psychiatric care for pregnant and new mothers can be challenging, but it is also immensely rewarding. Restoring a mother’s mental health usually leads to increased emotional stability for her entire family. Given the prevalence of maternal mental health disorders, psychiatrists in nearly every setting will encounter this population of women. With dedicated time devoted to reviewing the literature and learning about local resources, psychiatrists can feel comfortable treating women throughout the childbearing experience.

References

1. J Affect Disord. 2017 Sep;219:86-92.

2. J Psychiatr Res. 2018 Sep;104:235-48.

3. J Womens Health. (Larchmt). 2015 Sep;24(9):762-70.

4. Clin Psychol Rev. 2014 Jul;34(5):389-401.

5. Compr Psychiatry. 2009 Nov-Dec;50(6):503-9.

6. Int Rev Psychiatry. 2003 Aug;15(3):231-42.

7. Clin Obstet Gynecol. 2018 Sep;61(3):533-43.

8. Curr Opinion Psychiatry. 2012 Mar;25(2):141-8.

9. Am J Psychiatry. 2009 Apr;166(4):405-8.

Dr. Reinstein is a psychiatry attending at Zucker Hillside Hospital. Her clinical interests include reproductive psychiatry and family therapy, with a specific focus on maternal mental health. Dr. Reinstein completed her adult psychiatry residency training at Montefiore Hospital/Albert Einstein College of Medicine, New York, after graduating from the Albert Einstein College of Medicine and Yeshiva University, New York, with a BA in biology. She is one of the recipients of the 4th Annual Resident Recognition Award for Excellence in Family Oriented Care.

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Heart failure remains a common, costly concern

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Heart failure remains one of the deadliest chronic medical conditions, with 5-year mortality rates approaching 50%, and is the most common diagnosis for adults aged 65 years and older who are admitted to the hospital, according to Albert J. Hicks III, MD.

Dr. Albert J. Hicks III

Dr. Hicks, a cardiologist at Baylor Scott & White Health in Temple, Tex., will discuss the latest challenges and hottest topics surrounding heart failure in the “Updates in Heart Failure” session on Monday, at HM19.

The growth of an aging population in the United States further emphasizes the importance of heart failure as a topic of interest to clinicians, Dr. Hicks said in an interview. He noted that heart failure is the highest medical expenditure for Medicare, and estimates suggest the condition will cost the U.S. health care system $30 billion by the year 2030, he said. With these numbers in mind, the timing of referring patients to an advanced heart failure team is a key issue.

But the timing of referral for advanced care is just one of the hot topics on the agenda for the “Updates in Heart Failure” session, Dr. Hicks said. Other topics include heart failure epidemiology (incidence, prevalence, morbidity, mortality, and disparities); economics of heart failure (burden of care on the U.S. health care system); heart failure hospitalizations and readmissions (risk factors, comorbidities, patient compliance issues); pathophysiology (why heart failure is so deadly); signs and symptoms of heart failure (how to recognize them); treatment of stage C heart failure, with a review of old and new drugs and devices; and treatment of stage D heart failure, including palliative care, mechanical circulatory support, and heart transplantation.

Dr. Hicks’ primary goal for the session is to “increase awareness of the high mortality associated with a heart failure diagnosis,” he said. He also hopes to educate hospitalists about the latest medications, devices, and resources for heart failure patients and to give them the tools and knowledge to help reduce morbidity and mortality in their heart failure patients.

Session attendees also will benefit from Dr. Hicks’ practical advice on identifying warning signs that indicate a heart failure patient may need a medical assist device or a heart transplant and on encouraging early referral of heart failure patients to advanced heart failure specialists before irreversible end-organ damage occurs.

Dr. Hicks hypothesized that the high mortality associated with a heart failure diagnosis, hospital readmission, and late referral will generate the liveliest discussion because issues of costs and resources continue to evolve.

His take-home message: “Early recognition and referral of heart failure patients to a heart failure cardiologist can improve patient costs, morbidity, and survival.

Dr. Hicks had no relevant financial conflicts to disclose.

Updates in Heart Failure
Monday, 2:00-2:40 p.m.
Woodrow Wilson

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Heart failure remains one of the deadliest chronic medical conditions, with 5-year mortality rates approaching 50%, and is the most common diagnosis for adults aged 65 years and older who are admitted to the hospital, according to Albert J. Hicks III, MD.

Dr. Albert J. Hicks III

Dr. Hicks, a cardiologist at Baylor Scott & White Health in Temple, Tex., will discuss the latest challenges and hottest topics surrounding heart failure in the “Updates in Heart Failure” session on Monday, at HM19.

The growth of an aging population in the United States further emphasizes the importance of heart failure as a topic of interest to clinicians, Dr. Hicks said in an interview. He noted that heart failure is the highest medical expenditure for Medicare, and estimates suggest the condition will cost the U.S. health care system $30 billion by the year 2030, he said. With these numbers in mind, the timing of referring patients to an advanced heart failure team is a key issue.

But the timing of referral for advanced care is just one of the hot topics on the agenda for the “Updates in Heart Failure” session, Dr. Hicks said. Other topics include heart failure epidemiology (incidence, prevalence, morbidity, mortality, and disparities); economics of heart failure (burden of care on the U.S. health care system); heart failure hospitalizations and readmissions (risk factors, comorbidities, patient compliance issues); pathophysiology (why heart failure is so deadly); signs and symptoms of heart failure (how to recognize them); treatment of stage C heart failure, with a review of old and new drugs and devices; and treatment of stage D heart failure, including palliative care, mechanical circulatory support, and heart transplantation.

Dr. Hicks’ primary goal for the session is to “increase awareness of the high mortality associated with a heart failure diagnosis,” he said. He also hopes to educate hospitalists about the latest medications, devices, and resources for heart failure patients and to give them the tools and knowledge to help reduce morbidity and mortality in their heart failure patients.

Session attendees also will benefit from Dr. Hicks’ practical advice on identifying warning signs that indicate a heart failure patient may need a medical assist device or a heart transplant and on encouraging early referral of heart failure patients to advanced heart failure specialists before irreversible end-organ damage occurs.

Dr. Hicks hypothesized that the high mortality associated with a heart failure diagnosis, hospital readmission, and late referral will generate the liveliest discussion because issues of costs and resources continue to evolve.

His take-home message: “Early recognition and referral of heart failure patients to a heart failure cardiologist can improve patient costs, morbidity, and survival.

Dr. Hicks had no relevant financial conflicts to disclose.

Updates in Heart Failure
Monday, 2:00-2:40 p.m.
Woodrow Wilson

Heart failure remains one of the deadliest chronic medical conditions, with 5-year mortality rates approaching 50%, and is the most common diagnosis for adults aged 65 years and older who are admitted to the hospital, according to Albert J. Hicks III, MD.

Dr. Albert J. Hicks III

Dr. Hicks, a cardiologist at Baylor Scott & White Health in Temple, Tex., will discuss the latest challenges and hottest topics surrounding heart failure in the “Updates in Heart Failure” session on Monday, at HM19.

The growth of an aging population in the United States further emphasizes the importance of heart failure as a topic of interest to clinicians, Dr. Hicks said in an interview. He noted that heart failure is the highest medical expenditure for Medicare, and estimates suggest the condition will cost the U.S. health care system $30 billion by the year 2030, he said. With these numbers in mind, the timing of referring patients to an advanced heart failure team is a key issue.

But the timing of referral for advanced care is just one of the hot topics on the agenda for the “Updates in Heart Failure” session, Dr. Hicks said. Other topics include heart failure epidemiology (incidence, prevalence, morbidity, mortality, and disparities); economics of heart failure (burden of care on the U.S. health care system); heart failure hospitalizations and readmissions (risk factors, comorbidities, patient compliance issues); pathophysiology (why heart failure is so deadly); signs and symptoms of heart failure (how to recognize them); treatment of stage C heart failure, with a review of old and new drugs and devices; and treatment of stage D heart failure, including palliative care, mechanical circulatory support, and heart transplantation.

Dr. Hicks’ primary goal for the session is to “increase awareness of the high mortality associated with a heart failure diagnosis,” he said. He also hopes to educate hospitalists about the latest medications, devices, and resources for heart failure patients and to give them the tools and knowledge to help reduce morbidity and mortality in their heart failure patients.

Session attendees also will benefit from Dr. Hicks’ practical advice on identifying warning signs that indicate a heart failure patient may need a medical assist device or a heart transplant and on encouraging early referral of heart failure patients to advanced heart failure specialists before irreversible end-organ damage occurs.

Dr. Hicks hypothesized that the high mortality associated with a heart failure diagnosis, hospital readmission, and late referral will generate the liveliest discussion because issues of costs and resources continue to evolve.

His take-home message: “Early recognition and referral of heart failure patients to a heart failure cardiologist can improve patient costs, morbidity, and survival.

Dr. Hicks had no relevant financial conflicts to disclose.

Updates in Heart Failure
Monday, 2:00-2:40 p.m.
Woodrow Wilson

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There’s No Doubt: Blame the Drug

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There’s No Doubt: Blame the Drug

It’s taken 2 years for family members to convince this 50-year-old black woman to consult dermatology about dark circles on her arms and trunk. The asymptomatic lesions were only faintly discolored at manifestation but have darkened with each recurrence. The 6 lesions she currently has are in the exact locations they originally manifested in.

Convinced she had “ringworm,” the patient tried several different antifungal creams, to no avail. Then her primary care provider prescribed a 2-month course of oral antifungal medication (terbinafine)—again, with no change to the lesions.

The patient is otherwise healthy except for osteoarthritis, for which she takes ibuprofen (800 mg 2 or 3 times a day). She denies any history of seizure, chronic urinary tract infection, or other chronic infection.

There’s No Doubt: Blame the Drug

EXAMINATION
The 6 perfectly round, uniformly pigmented, dark brown macular lesions on the patient’s arms and trunk range from 2 to 5 cm in diameter. A faint, rusty brown halo can be seen around the periphery of the lesions, giving them a targetoid look. The surfaces of the lesions are completely smooth.

What’s the diagnosis?

 

 

DISCUSSION
The list of dark brown, round macules that come and go in the exact same locations is a short one—in fact, it only includes fixed drug eruption (FDE). This is a unique adverse reaction to one of several medications; common culprits are ibuprofen or other NSAIDs, aspirin, members of the sulfa family, penicillin, and several antiseizure medications.

The exact mechanism for this reaction is unknown, but it does appear to involve the localized production of cytokines. There is a range of morphologic presentations for FDE: some lesions are more targetoid than others; some are darker (especially in patients with darker skin) while others are more pink.

Furthermore, many patients develop additional lesions over time. A few, on the other hand, will reach a point at which they stop reacting to the offending product.

Of all the drugs causing FDE, sulfa-based products are among the more consistent offenders. Thus, we always ask about chronic urinary tract infections.

TAKE-HOME LEARNING POINTS

  • Fixed drug eruptions (FDE) usually manifest with round, targetoid macules that are occasionally blistery.
  • The lesions recur or darken with each “challenge” from the drug, which can be one of several potential offenders.
  • The fact that the lesions keep recurring in the same location (ie, fixed) is pathognomic for FDE.
  • FDE lesions can occur almost anywhere on the body—even on palms or soles.
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It’s taken 2 years for family members to convince this 50-year-old black woman to consult dermatology about dark circles on her arms and trunk. The asymptomatic lesions were only faintly discolored at manifestation but have darkened with each recurrence. The 6 lesions she currently has are in the exact locations they originally manifested in.

Convinced she had “ringworm,” the patient tried several different antifungal creams, to no avail. Then her primary care provider prescribed a 2-month course of oral antifungal medication (terbinafine)—again, with no change to the lesions.

The patient is otherwise healthy except for osteoarthritis, for which she takes ibuprofen (800 mg 2 or 3 times a day). She denies any history of seizure, chronic urinary tract infection, or other chronic infection.

There’s No Doubt: Blame the Drug

EXAMINATION
The 6 perfectly round, uniformly pigmented, dark brown macular lesions on the patient’s arms and trunk range from 2 to 5 cm in diameter. A faint, rusty brown halo can be seen around the periphery of the lesions, giving them a targetoid look. The surfaces of the lesions are completely smooth.

What’s the diagnosis?

 

 

DISCUSSION
The list of dark brown, round macules that come and go in the exact same locations is a short one—in fact, it only includes fixed drug eruption (FDE). This is a unique adverse reaction to one of several medications; common culprits are ibuprofen or other NSAIDs, aspirin, members of the sulfa family, penicillin, and several antiseizure medications.

The exact mechanism for this reaction is unknown, but it does appear to involve the localized production of cytokines. There is a range of morphologic presentations for FDE: some lesions are more targetoid than others; some are darker (especially in patients with darker skin) while others are more pink.

Furthermore, many patients develop additional lesions over time. A few, on the other hand, will reach a point at which they stop reacting to the offending product.

Of all the drugs causing FDE, sulfa-based products are among the more consistent offenders. Thus, we always ask about chronic urinary tract infections.

TAKE-HOME LEARNING POINTS

  • Fixed drug eruptions (FDE) usually manifest with round, targetoid macules that are occasionally blistery.
  • The lesions recur or darken with each “challenge” from the drug, which can be one of several potential offenders.
  • The fact that the lesions keep recurring in the same location (ie, fixed) is pathognomic for FDE.
  • FDE lesions can occur almost anywhere on the body—even on palms or soles.

It’s taken 2 years for family members to convince this 50-year-old black woman to consult dermatology about dark circles on her arms and trunk. The asymptomatic lesions were only faintly discolored at manifestation but have darkened with each recurrence. The 6 lesions she currently has are in the exact locations they originally manifested in.

Convinced she had “ringworm,” the patient tried several different antifungal creams, to no avail. Then her primary care provider prescribed a 2-month course of oral antifungal medication (terbinafine)—again, with no change to the lesions.

The patient is otherwise healthy except for osteoarthritis, for which she takes ibuprofen (800 mg 2 or 3 times a day). She denies any history of seizure, chronic urinary tract infection, or other chronic infection.

There’s No Doubt: Blame the Drug

EXAMINATION
The 6 perfectly round, uniformly pigmented, dark brown macular lesions on the patient’s arms and trunk range from 2 to 5 cm in diameter. A faint, rusty brown halo can be seen around the periphery of the lesions, giving them a targetoid look. The surfaces of the lesions are completely smooth.

What’s the diagnosis?

 

 

DISCUSSION
The list of dark brown, round macules that come and go in the exact same locations is a short one—in fact, it only includes fixed drug eruption (FDE). This is a unique adverse reaction to one of several medications; common culprits are ibuprofen or other NSAIDs, aspirin, members of the sulfa family, penicillin, and several antiseizure medications.

The exact mechanism for this reaction is unknown, but it does appear to involve the localized production of cytokines. There is a range of morphologic presentations for FDE: some lesions are more targetoid than others; some are darker (especially in patients with darker skin) while others are more pink.

Furthermore, many patients develop additional lesions over time. A few, on the other hand, will reach a point at which they stop reacting to the offending product.

Of all the drugs causing FDE, sulfa-based products are among the more consistent offenders. Thus, we always ask about chronic urinary tract infections.

TAKE-HOME LEARNING POINTS

  • Fixed drug eruptions (FDE) usually manifest with round, targetoid macules that are occasionally blistery.
  • The lesions recur or darken with each “challenge” from the drug, which can be one of several potential offenders.
  • The fact that the lesions keep recurring in the same location (ie, fixed) is pathognomic for FDE.
  • FDE lesions can occur almost anywhere on the body—even on palms or soles.
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Hospital-onset sepsis twice as lethal as community-onset disease

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Tue, 03/19/2019 - 08:52

 

– Patients who develop sepsis in the hospital appear to be in greater risk for mortality than those who bring it with them, a new study suggests. Patients with hospital-onset sepsis were twice as likely to die as those infected in the outside world.

MDedge News/Randy Dotinga
Dr. Chanu Rhee

“There could be some differences in quality of care that explains the difference in mortality,” said study lead author Chanu Rhee, MD, assistant professor of population medicine at Harvard Medical School, Boston, in a presentation about the findings at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

In an interview, Dr. Rhee said researchers launched the study to gain a greater understanding of the epidemiology of sepsis in the hospital. They relied on a new Centers for Disease Control and Prevention definition of sepsis that is “enhancing the consistency of surveillance across hospitals and allowing more precise differentiation between hospital-onset versus community-onset sepsis.”

The study authors retrospectively tracked more than 2.2 million patients who were treated at 136 U.S. hospitals from 2009 to 2015. In general, hospital-onset sepsis was defined as patients who had a blood culture, initial antibiotic therapy, and organ dysfunction on their third day in the hospital or later.*

Of the patients, 83,600 had community-onset sepsis and 11,500 had hospital-onset sepsis. Those with sepsis were more likely to be men and have comorbidities such as cancer, congestive heart failure, diabetes, and renal disease.

Patients with hospital-onset sepsis had longer median lengths of stay (19 days) than the community-onset group (8 days) and the no-sepsis group (4 days). The hospital-onset group also had a greater likelihood of ICU admission (61%) than the community-onset (44%) and no-sepsis (9%) groups.

About 34% of those with hospital-onset sepsis died, compared with 17% of the community-onset group and 2% of the patients who didn’t have sepsis. After adjustment, those with hospital-onset sepsis were still more likely to have died (odds ratio, 2.1; 95% confidence interval, 2.0-2.2).

“Other studies have suggested that there may be delays in the recognition and care of patients who develop sepsis in the hospital as opposed to presenting to the hospital with sepsis,” Dr. Rhee said. “It is also possible that hospital-onset sepsis tends to be caused by organisms that are more virulent and resistant to antibiotics.”

Overall, he said, “our findings underscore the importance of targeting hospital-onset sepsis with surveillance, prevention, and quality improvement efforts.”

The study was funded by the CDC and the Agency for Healthcare Research and Quality. The authors reported no relevant disclosures.

SOURCE: Rhee C et al. CCC48, Abstract 29.

*Correction, 3/19/19: An earlier version of this article misstated the definition of sepsis.

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– Patients who develop sepsis in the hospital appear to be in greater risk for mortality than those who bring it with them, a new study suggests. Patients with hospital-onset sepsis were twice as likely to die as those infected in the outside world.

MDedge News/Randy Dotinga
Dr. Chanu Rhee

“There could be some differences in quality of care that explains the difference in mortality,” said study lead author Chanu Rhee, MD, assistant professor of population medicine at Harvard Medical School, Boston, in a presentation about the findings at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

In an interview, Dr. Rhee said researchers launched the study to gain a greater understanding of the epidemiology of sepsis in the hospital. They relied on a new Centers for Disease Control and Prevention definition of sepsis that is “enhancing the consistency of surveillance across hospitals and allowing more precise differentiation between hospital-onset versus community-onset sepsis.”

The study authors retrospectively tracked more than 2.2 million patients who were treated at 136 U.S. hospitals from 2009 to 2015. In general, hospital-onset sepsis was defined as patients who had a blood culture, initial antibiotic therapy, and organ dysfunction on their third day in the hospital or later.*

Of the patients, 83,600 had community-onset sepsis and 11,500 had hospital-onset sepsis. Those with sepsis were more likely to be men and have comorbidities such as cancer, congestive heart failure, diabetes, and renal disease.

Patients with hospital-onset sepsis had longer median lengths of stay (19 days) than the community-onset group (8 days) and the no-sepsis group (4 days). The hospital-onset group also had a greater likelihood of ICU admission (61%) than the community-onset (44%) and no-sepsis (9%) groups.

About 34% of those with hospital-onset sepsis died, compared with 17% of the community-onset group and 2% of the patients who didn’t have sepsis. After adjustment, those with hospital-onset sepsis were still more likely to have died (odds ratio, 2.1; 95% confidence interval, 2.0-2.2).

“Other studies have suggested that there may be delays in the recognition and care of patients who develop sepsis in the hospital as opposed to presenting to the hospital with sepsis,” Dr. Rhee said. “It is also possible that hospital-onset sepsis tends to be caused by organisms that are more virulent and resistant to antibiotics.”

Overall, he said, “our findings underscore the importance of targeting hospital-onset sepsis with surveillance, prevention, and quality improvement efforts.”

The study was funded by the CDC and the Agency for Healthcare Research and Quality. The authors reported no relevant disclosures.

SOURCE: Rhee C et al. CCC48, Abstract 29.

*Correction, 3/19/19: An earlier version of this article misstated the definition of sepsis.

 

– Patients who develop sepsis in the hospital appear to be in greater risk for mortality than those who bring it with them, a new study suggests. Patients with hospital-onset sepsis were twice as likely to die as those infected in the outside world.

MDedge News/Randy Dotinga
Dr. Chanu Rhee

“There could be some differences in quality of care that explains the difference in mortality,” said study lead author Chanu Rhee, MD, assistant professor of population medicine at Harvard Medical School, Boston, in a presentation about the findings at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

In an interview, Dr. Rhee said researchers launched the study to gain a greater understanding of the epidemiology of sepsis in the hospital. They relied on a new Centers for Disease Control and Prevention definition of sepsis that is “enhancing the consistency of surveillance across hospitals and allowing more precise differentiation between hospital-onset versus community-onset sepsis.”

The study authors retrospectively tracked more than 2.2 million patients who were treated at 136 U.S. hospitals from 2009 to 2015. In general, hospital-onset sepsis was defined as patients who had a blood culture, initial antibiotic therapy, and organ dysfunction on their third day in the hospital or later.*

Of the patients, 83,600 had community-onset sepsis and 11,500 had hospital-onset sepsis. Those with sepsis were more likely to be men and have comorbidities such as cancer, congestive heart failure, diabetes, and renal disease.

Patients with hospital-onset sepsis had longer median lengths of stay (19 days) than the community-onset group (8 days) and the no-sepsis group (4 days). The hospital-onset group also had a greater likelihood of ICU admission (61%) than the community-onset (44%) and no-sepsis (9%) groups.

About 34% of those with hospital-onset sepsis died, compared with 17% of the community-onset group and 2% of the patients who didn’t have sepsis. After adjustment, those with hospital-onset sepsis were still more likely to have died (odds ratio, 2.1; 95% confidence interval, 2.0-2.2).

“Other studies have suggested that there may be delays in the recognition and care of patients who develop sepsis in the hospital as opposed to presenting to the hospital with sepsis,” Dr. Rhee said. “It is also possible that hospital-onset sepsis tends to be caused by organisms that are more virulent and resistant to antibiotics.”

Overall, he said, “our findings underscore the importance of targeting hospital-onset sepsis with surveillance, prevention, and quality improvement efforts.”

The study was funded by the CDC and the Agency for Healthcare Research and Quality. The authors reported no relevant disclosures.

SOURCE: Rhee C et al. CCC48, Abstract 29.

*Correction, 3/19/19: An earlier version of this article misstated the definition of sepsis.

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Pigmentation on foot

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Pigmentation on foot

Pigmentation on foot

The FP suspected that this was an acral lentiginous melanoma (ALM).

The FP considered the various ways to biopsy this lesion. Doing a biopsy of the whole lesion was neither practical, nor desirable, given that the lesion was >2 cm and located on the bottom of the patient’s foot. And while incomplete sampling could result in a false negative result, this lesion was so suspicious for melanoma that any well-performed biopsy would likely produce a diagnosis of melanoma. (Of course if melanoma was not diagnosable with partial sampling, a full excisional biopsy would be needed.)

The FP also debated doing a 6-mm punch biopsy vs a shave biopsy; his intent was to get below some of the deeper pigment. Incisional biopsy done as a small ellipse with suturing was also an option. It would also be the most time consuming.

The FP presented the biopsy options to the patient and explained that the shave biopsy would require a dressing and the punch biopsy would require sutures, which would need to be removed at the next visit. Both biopsy methods would likely cause the foot to be uncomfortable to walk on for several days.

The FP and patient decided to do a deep shave biopsy (saucerization). After administering local anesthesia with lidocaine and epinephrine, the FP performed a deep shave biopsy that included about 1 cm of the darkest and thickest portion of the suspected melanoma.

The biopsy results indicated that the patient had an acral lentiginous melanoma, which measured 0.7 mm at its deepest point in the biopsied portion. The patient was referred to Orthopedics for a wide excision and repair. A sentinel node biopsy was not needed because the lesion was less than 1 mm in depth and there was no ulceration. The surgery and healing time were challenging for the patient, but she did not lose her foot and has remained cancer free.

Photo courtesy of Jonathan Karnes, MD and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1103-1111.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

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The Journal of Family Practice - 68(2)
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Pigmentation on foot

The FP suspected that this was an acral lentiginous melanoma (ALM).

The FP considered the various ways to biopsy this lesion. Doing a biopsy of the whole lesion was neither practical, nor desirable, given that the lesion was >2 cm and located on the bottom of the patient’s foot. And while incomplete sampling could result in a false negative result, this lesion was so suspicious for melanoma that any well-performed biopsy would likely produce a diagnosis of melanoma. (Of course if melanoma was not diagnosable with partial sampling, a full excisional biopsy would be needed.)

The FP also debated doing a 6-mm punch biopsy vs a shave biopsy; his intent was to get below some of the deeper pigment. Incisional biopsy done as a small ellipse with suturing was also an option. It would also be the most time consuming.

The FP presented the biopsy options to the patient and explained that the shave biopsy would require a dressing and the punch biopsy would require sutures, which would need to be removed at the next visit. Both biopsy methods would likely cause the foot to be uncomfortable to walk on for several days.

The FP and patient decided to do a deep shave biopsy (saucerization). After administering local anesthesia with lidocaine and epinephrine, the FP performed a deep shave biopsy that included about 1 cm of the darkest and thickest portion of the suspected melanoma.

The biopsy results indicated that the patient had an acral lentiginous melanoma, which measured 0.7 mm at its deepest point in the biopsied portion. The patient was referred to Orthopedics for a wide excision and repair. A sentinel node biopsy was not needed because the lesion was less than 1 mm in depth and there was no ulceration. The surgery and healing time were challenging for the patient, but she did not lose her foot and has remained cancer free.

Photo courtesy of Jonathan Karnes, MD and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1103-1111.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

Pigmentation on foot

The FP suspected that this was an acral lentiginous melanoma (ALM).

The FP considered the various ways to biopsy this lesion. Doing a biopsy of the whole lesion was neither practical, nor desirable, given that the lesion was >2 cm and located on the bottom of the patient’s foot. And while incomplete sampling could result in a false negative result, this lesion was so suspicious for melanoma that any well-performed biopsy would likely produce a diagnosis of melanoma. (Of course if melanoma was not diagnosable with partial sampling, a full excisional biopsy would be needed.)

The FP also debated doing a 6-mm punch biopsy vs a shave biopsy; his intent was to get below some of the deeper pigment. Incisional biopsy done as a small ellipse with suturing was also an option. It would also be the most time consuming.

The FP presented the biopsy options to the patient and explained that the shave biopsy would require a dressing and the punch biopsy would require sutures, which would need to be removed at the next visit. Both biopsy methods would likely cause the foot to be uncomfortable to walk on for several days.

The FP and patient decided to do a deep shave biopsy (saucerization). After administering local anesthesia with lidocaine and epinephrine, the FP performed a deep shave biopsy that included about 1 cm of the darkest and thickest portion of the suspected melanoma.

The biopsy results indicated that the patient had an acral lentiginous melanoma, which measured 0.7 mm at its deepest point in the biopsied portion. The patient was referred to Orthopedics for a wide excision and repair. A sentinel node biopsy was not needed because the lesion was less than 1 mm in depth and there was no ulceration. The surgery and healing time were challenging for the patient, but she did not lose her foot and has remained cancer free.

Photo courtesy of Jonathan Karnes, MD and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1103-1111.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

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The Journal of Family Practice - 68(2)
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The Journal of Family Practice - 68(2)
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