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Lucas Franki is an associate editor for MDedge News, and has been with the company since 2014. He has a BA in English from Penn State University and is an Eagle Scout.
Social anxiety more likely with inattentive ADHD, psychiatric comorbidities
Social anxiety is more likely in adolescents aged 12-18 years with predominantly inattentive ADHD and psychiatric comorbidities, according to María Jesús Mardomingo-Sanz, MD, PhD, and associates.
A total of 234 ADHD patients with a mean age of 14.9 years were recruited for the cross-sectional, observational study, and social anxiety was assessed using the Social Anxiety Scale for Adolescents (SAS-A). Just under 70% were male; 37.2% had predominantly inattentive disease, 9% had predominantly hyperactive-impulsive disease, and 51.7% had combined-type disease. , reported Dr. Mardomingo-Sanz, of the child psychiatry and psychology section at the Hospital General Universitario Gregorio Marañón in Madrid, and associates. The study was published in Anales de Pediatría.
The investigators found that 50.4% of patients had a psychiatric comorbidity. Learning and communication disorders, and anxiety disorders were the most common, occurring in 20.1% and 19.2% of all patients, respectively. Patients within the cohort scored significantly higher on the SAS-A, compared with reference values in a healthy population.
Patients with predominantly inattentive disease had significantly higher scores in the SAS-A, compared with those with predominantly hyperactive-impulsive disease (P = .015). Comorbid anxiety disorder was associated with the worst SAS-A scores (P less than .001).
“Social anxiety greatly influences the way in which children and adolescents interact with the surrounding environment and react to it, and therefore can contribute to the development of psychiatric comorbidities. Social anxiety detected by the SAS-A questionnaire is not diagnostic of an anxiety disorder, but detecting it is important, as it can contribute to the secondary prevention of future comorbidities that could lead to less favorable outcomes of these stage of development in patients with ADHD,” the investigators concluded.
Laboratorios Farmacéuticos funded the study, and the investigators reported receiving fees and being employed by Laboratorios Farmacéuticos.
SOURCE: Mardomingo-Sanz MJ et al. An Pediatr (Barc). 2019;90(6):349-61.
Social anxiety is more likely in adolescents aged 12-18 years with predominantly inattentive ADHD and psychiatric comorbidities, according to María Jesús Mardomingo-Sanz, MD, PhD, and associates.
A total of 234 ADHD patients with a mean age of 14.9 years were recruited for the cross-sectional, observational study, and social anxiety was assessed using the Social Anxiety Scale for Adolescents (SAS-A). Just under 70% were male; 37.2% had predominantly inattentive disease, 9% had predominantly hyperactive-impulsive disease, and 51.7% had combined-type disease. , reported Dr. Mardomingo-Sanz, of the child psychiatry and psychology section at the Hospital General Universitario Gregorio Marañón in Madrid, and associates. The study was published in Anales de Pediatría.
The investigators found that 50.4% of patients had a psychiatric comorbidity. Learning and communication disorders, and anxiety disorders were the most common, occurring in 20.1% and 19.2% of all patients, respectively. Patients within the cohort scored significantly higher on the SAS-A, compared with reference values in a healthy population.
Patients with predominantly inattentive disease had significantly higher scores in the SAS-A, compared with those with predominantly hyperactive-impulsive disease (P = .015). Comorbid anxiety disorder was associated with the worst SAS-A scores (P less than .001).
“Social anxiety greatly influences the way in which children and adolescents interact with the surrounding environment and react to it, and therefore can contribute to the development of psychiatric comorbidities. Social anxiety detected by the SAS-A questionnaire is not diagnostic of an anxiety disorder, but detecting it is important, as it can contribute to the secondary prevention of future comorbidities that could lead to less favorable outcomes of these stage of development in patients with ADHD,” the investigators concluded.
Laboratorios Farmacéuticos funded the study, and the investigators reported receiving fees and being employed by Laboratorios Farmacéuticos.
SOURCE: Mardomingo-Sanz MJ et al. An Pediatr (Barc). 2019;90(6):349-61.
Social anxiety is more likely in adolescents aged 12-18 years with predominantly inattentive ADHD and psychiatric comorbidities, according to María Jesús Mardomingo-Sanz, MD, PhD, and associates.
A total of 234 ADHD patients with a mean age of 14.9 years were recruited for the cross-sectional, observational study, and social anxiety was assessed using the Social Anxiety Scale for Adolescents (SAS-A). Just under 70% were male; 37.2% had predominantly inattentive disease, 9% had predominantly hyperactive-impulsive disease, and 51.7% had combined-type disease. , reported Dr. Mardomingo-Sanz, of the child psychiatry and psychology section at the Hospital General Universitario Gregorio Marañón in Madrid, and associates. The study was published in Anales de Pediatría.
The investigators found that 50.4% of patients had a psychiatric comorbidity. Learning and communication disorders, and anxiety disorders were the most common, occurring in 20.1% and 19.2% of all patients, respectively. Patients within the cohort scored significantly higher on the SAS-A, compared with reference values in a healthy population.
Patients with predominantly inattentive disease had significantly higher scores in the SAS-A, compared with those with predominantly hyperactive-impulsive disease (P = .015). Comorbid anxiety disorder was associated with the worst SAS-A scores (P less than .001).
“Social anxiety greatly influences the way in which children and adolescents interact with the surrounding environment and react to it, and therefore can contribute to the development of psychiatric comorbidities. Social anxiety detected by the SAS-A questionnaire is not diagnostic of an anxiety disorder, but detecting it is important, as it can contribute to the secondary prevention of future comorbidities that could lead to less favorable outcomes of these stage of development in patients with ADHD,” the investigators concluded.
Laboratorios Farmacéuticos funded the study, and the investigators reported receiving fees and being employed by Laboratorios Farmacéuticos.
SOURCE: Mardomingo-Sanz MJ et al. An Pediatr (Barc). 2019;90(6):349-61.
FROM ANALES DE PEDIATRÍA
First generics for Gilenya approved by FDA
The Food and Drug Administration has approved the first generics of fingolimod (Gilenya) for the treatment of relapsing forms of multiple sclerosis.
The three generic fingolimod applications came from HEC Pharm, Biocon, and Sun Pharmaceutical Industries.
Fingolimod is a widely used, orally administered treatment option for relapsing forms of multiple sclerosis in adults. The most common adverse events associated with fingolimod in clinical trials include headache, elevation of liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in the extremities.
The drug must be dispensed with a medication guide that contains important information on its usage and risk, the FDA noted. Serious risks associated with fingolimod include slowing of the heart rate, vision problems, posterior reversible encephalopathy syndrome, respiratory problems, liver injury, increased blood pressure, skin cancer, and risk of serious infection including a rare and often deadly brain infection called progressive multifocal leukoencephalopathy. Fingolimod can also cause harm to a developing fetus.
Find the full press release on the FDA website.
The Food and Drug Administration has approved the first generics of fingolimod (Gilenya) for the treatment of relapsing forms of multiple sclerosis.
The three generic fingolimod applications came from HEC Pharm, Biocon, and Sun Pharmaceutical Industries.
Fingolimod is a widely used, orally administered treatment option for relapsing forms of multiple sclerosis in adults. The most common adverse events associated with fingolimod in clinical trials include headache, elevation of liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in the extremities.
The drug must be dispensed with a medication guide that contains important information on its usage and risk, the FDA noted. Serious risks associated with fingolimod include slowing of the heart rate, vision problems, posterior reversible encephalopathy syndrome, respiratory problems, liver injury, increased blood pressure, skin cancer, and risk of serious infection including a rare and often deadly brain infection called progressive multifocal leukoencephalopathy. Fingolimod can also cause harm to a developing fetus.
Find the full press release on the FDA website.
The Food and Drug Administration has approved the first generics of fingolimod (Gilenya) for the treatment of relapsing forms of multiple sclerosis.
The three generic fingolimod applications came from HEC Pharm, Biocon, and Sun Pharmaceutical Industries.
Fingolimod is a widely used, orally administered treatment option for relapsing forms of multiple sclerosis in adults. The most common adverse events associated with fingolimod in clinical trials include headache, elevation of liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in the extremities.
The drug must be dispensed with a medication guide that contains important information on its usage and risk, the FDA noted. Serious risks associated with fingolimod include slowing of the heart rate, vision problems, posterior reversible encephalopathy syndrome, respiratory problems, liver injury, increased blood pressure, skin cancer, and risk of serious infection including a rare and often deadly brain infection called progressive multifocal leukoencephalopathy. Fingolimod can also cause harm to a developing fetus.
Find the full press release on the FDA website.
Benefits and drawbacks found for risk-based lung cancer screening tools
Risk-based lung cancer screening tools can prevent significantly more lung cancer deaths than the current United States Preventive Services Task Force recommendations, but life-year gains were negligible or reduced and patients would experience greater overdiagnosis, according to new research.
“Current guidelines propose screening eligibility using age and smoking-related criteria, through combinations of accumulated pack-years and years since smoking cessation,” Kevin ten Haaf, PhD, of the department of public health at Erasmus Medical Center in Rotterdam, the Netherlands, and associates wrote in the Journal of the National Cancer Institute. “The USPSTF recommends annual screening between the ages of 55 and 80 years for current and former smokers (quit less than 15 years) who smoked 30 or more pack-years.”
Individual risk assessment utilizing established lung cancer risk–prediction models may have some superiority over pack-years in identifying those most likely to benefit from screening, they wrote, because the models incorporate smoking history in greater detail and consider risk factors such as chronic obstructive pulmonary disease.
Three risk-assessment models were used for the study, in addition to the USPSTF guidelines: the Bach, PLCOm2012, and Lung Cancer Death Risk Assessment Tool (LCDRAT). The study population was a simulated 1950 U.S. cohort from the Smoking History Generator aged between 55 years and 80 years; each simulated smoking history consists of whether and when the person initiates and ceases smoking, average number of cigarettes smoked per day by age, and the age of death from non–lung cancer causes.
The number of lung cancer deaths averted was significantly higher in the risk-based models, compared with the USPSTF recommendations (Bach, 693 per 100,000 population; PLCOm2012, 698 per 100,000 population; LCDRAT, 696 per 100,000 population; USPSTF, 613 per 100,000 population).
However, life-years gained was only modestly higher in the models, compared with the guideline (Bach, 8,660 per 100,000 life-years; PLCOm2012, 8,862 per 100,000 life-years; LCDRAT, 8,631 per 100,000 life-years; USPSTF, 8,590 per 100,000 life-years). In addition, life-years gained for every lung cancer death prevented was greater in the guideline (14.0 years) than in the risk-based models (12.1-12.4 years).
Overdiagnosis was also more common using risk-based tools (Bach, 149 per 100,000; PLCOm2012, 147 per 100,000; LCDRAT, 150 per 100,000; USPSTF, 115 per 100,000). This was mainly because of eligibility for risk-based screening tools increasing with age, the investigators noted.
According to a sensitivity analysis, risk-based models would retain the life-years gained by the USPSTF model if individuals with limited life expectancies (less than 5 years) were excluded. This would also reduce overdiagnosis by 65.3%.
“Future studies should investigate the cost-effectiveness of risk-based screening and the potential for reducing overdiagnosis in high-risk individuals,” the investigators concluded.
One coauthor developed the PLCOm2012 model, but the model is available free to noncommercial users, and the investigator has received no money from its usage. No other conflicts of interest were reported.
SOURCE: ten Haaf K et al. J Natl Cancer Inst. 2019 Nov 29. doi: 10.1093/jnci/djz164.
Risk-based lung cancer screening tools can prevent significantly more lung cancer deaths than the current United States Preventive Services Task Force recommendations, but life-year gains were negligible or reduced and patients would experience greater overdiagnosis, according to new research.
“Current guidelines propose screening eligibility using age and smoking-related criteria, through combinations of accumulated pack-years and years since smoking cessation,” Kevin ten Haaf, PhD, of the department of public health at Erasmus Medical Center in Rotterdam, the Netherlands, and associates wrote in the Journal of the National Cancer Institute. “The USPSTF recommends annual screening between the ages of 55 and 80 years for current and former smokers (quit less than 15 years) who smoked 30 or more pack-years.”
Individual risk assessment utilizing established lung cancer risk–prediction models may have some superiority over pack-years in identifying those most likely to benefit from screening, they wrote, because the models incorporate smoking history in greater detail and consider risk factors such as chronic obstructive pulmonary disease.
Three risk-assessment models were used for the study, in addition to the USPSTF guidelines: the Bach, PLCOm2012, and Lung Cancer Death Risk Assessment Tool (LCDRAT). The study population was a simulated 1950 U.S. cohort from the Smoking History Generator aged between 55 years and 80 years; each simulated smoking history consists of whether and when the person initiates and ceases smoking, average number of cigarettes smoked per day by age, and the age of death from non–lung cancer causes.
The number of lung cancer deaths averted was significantly higher in the risk-based models, compared with the USPSTF recommendations (Bach, 693 per 100,000 population; PLCOm2012, 698 per 100,000 population; LCDRAT, 696 per 100,000 population; USPSTF, 613 per 100,000 population).
However, life-years gained was only modestly higher in the models, compared with the guideline (Bach, 8,660 per 100,000 life-years; PLCOm2012, 8,862 per 100,000 life-years; LCDRAT, 8,631 per 100,000 life-years; USPSTF, 8,590 per 100,000 life-years). In addition, life-years gained for every lung cancer death prevented was greater in the guideline (14.0 years) than in the risk-based models (12.1-12.4 years).
Overdiagnosis was also more common using risk-based tools (Bach, 149 per 100,000; PLCOm2012, 147 per 100,000; LCDRAT, 150 per 100,000; USPSTF, 115 per 100,000). This was mainly because of eligibility for risk-based screening tools increasing with age, the investigators noted.
According to a sensitivity analysis, risk-based models would retain the life-years gained by the USPSTF model if individuals with limited life expectancies (less than 5 years) were excluded. This would also reduce overdiagnosis by 65.3%.
“Future studies should investigate the cost-effectiveness of risk-based screening and the potential for reducing overdiagnosis in high-risk individuals,” the investigators concluded.
One coauthor developed the PLCOm2012 model, but the model is available free to noncommercial users, and the investigator has received no money from its usage. No other conflicts of interest were reported.
SOURCE: ten Haaf K et al. J Natl Cancer Inst. 2019 Nov 29. doi: 10.1093/jnci/djz164.
Risk-based lung cancer screening tools can prevent significantly more lung cancer deaths than the current United States Preventive Services Task Force recommendations, but life-year gains were negligible or reduced and patients would experience greater overdiagnosis, according to new research.
“Current guidelines propose screening eligibility using age and smoking-related criteria, through combinations of accumulated pack-years and years since smoking cessation,” Kevin ten Haaf, PhD, of the department of public health at Erasmus Medical Center in Rotterdam, the Netherlands, and associates wrote in the Journal of the National Cancer Institute. “The USPSTF recommends annual screening between the ages of 55 and 80 years for current and former smokers (quit less than 15 years) who smoked 30 or more pack-years.”
Individual risk assessment utilizing established lung cancer risk–prediction models may have some superiority over pack-years in identifying those most likely to benefit from screening, they wrote, because the models incorporate smoking history in greater detail and consider risk factors such as chronic obstructive pulmonary disease.
Three risk-assessment models were used for the study, in addition to the USPSTF guidelines: the Bach, PLCOm2012, and Lung Cancer Death Risk Assessment Tool (LCDRAT). The study population was a simulated 1950 U.S. cohort from the Smoking History Generator aged between 55 years and 80 years; each simulated smoking history consists of whether and when the person initiates and ceases smoking, average number of cigarettes smoked per day by age, and the age of death from non–lung cancer causes.
The number of lung cancer deaths averted was significantly higher in the risk-based models, compared with the USPSTF recommendations (Bach, 693 per 100,000 population; PLCOm2012, 698 per 100,000 population; LCDRAT, 696 per 100,000 population; USPSTF, 613 per 100,000 population).
However, life-years gained was only modestly higher in the models, compared with the guideline (Bach, 8,660 per 100,000 life-years; PLCOm2012, 8,862 per 100,000 life-years; LCDRAT, 8,631 per 100,000 life-years; USPSTF, 8,590 per 100,000 life-years). In addition, life-years gained for every lung cancer death prevented was greater in the guideline (14.0 years) than in the risk-based models (12.1-12.4 years).
Overdiagnosis was also more common using risk-based tools (Bach, 149 per 100,000; PLCOm2012, 147 per 100,000; LCDRAT, 150 per 100,000; USPSTF, 115 per 100,000). This was mainly because of eligibility for risk-based screening tools increasing with age, the investigators noted.
According to a sensitivity analysis, risk-based models would retain the life-years gained by the USPSTF model if individuals with limited life expectancies (less than 5 years) were excluded. This would also reduce overdiagnosis by 65.3%.
“Future studies should investigate the cost-effectiveness of risk-based screening and the potential for reducing overdiagnosis in high-risk individuals,” the investigators concluded.
One coauthor developed the PLCOm2012 model, but the model is available free to noncommercial users, and the investigator has received no money from its usage. No other conflicts of interest were reported.
SOURCE: ten Haaf K et al. J Natl Cancer Inst. 2019 Nov 29. doi: 10.1093/jnci/djz164.
FROM THE JOURNAL OF THE NATIONAL CANCER INSTITUTE
Prosody recognition associated with functioning in first-episode schizophrenia
Affective prosody recognition is associated with role and social functioning in patients with a recent first episode of schizophrenia, according to Kelsey A. Bonfils, PhD, and associates.
The investigators conducted an analysis of 49 patients aged between 18 and 45 years with a recent first episode of schizophrenia who were participating in a larger randomized, controlled trial. Symptoms of schizophrenia were assessed using a 24-item version of the Brief Psychiatric Rating Scale (BPRS) and functioning was assessed using the Global Functioning Scale (GFS) and Role Functioning Scale (RFS). Study participants took the Prosody Task, which assessed the ability to recognize happiness, sadness, anger, fear, and disgust, and the Facial Emotion Identification Test (FEIT), which assesses the ability to recognize happiness, sadness, anger, fear, surprise, and disgust, reported Dr. Bonfils of the Veterans Affairs Pittsburgh Healthcare System and the department of psychiatry at the University of Pittsburgh. The study was published in Schizophrenia Research: Cognition.
In the Prosody Task, patients were significantly more likely to recognize anger (45.6% correct) and sadness (43.8%), and significantly less likely to recognize disgust (21.9%). In the FEIT, patients were most likely to recognize happiness (97.5%), followed by surprise (90.0%), anger (85.0%), sadness (77.5%), disgust (73.8%), and fear (55.0%).
Performance in the Prosody Task was associated with GFS role functioning and RFS social functioning, while FEIT performance was not significantly associated with any functioning measure. In terms of symptoms, Prosody Task performance was negatively associated with disorganization in the BPRS, and FEIT performance was associated with disorganization, reality distortion, and positive symptoms.
“These findings are consistent with the view that emotion recognition deficits could be contributing to deficits in the ability of people with first-episode schizophrenia to adequately function in the real world, both in relationships with friends and in normative young adult roles,” the investigators wrote.
Dr. Bonfils reported no conflicts of interest. Three coauthors reported receiving support, research grants, and funding from several pharmaceutical companies.
SOURCE: Bonfils KA et al. Schizophr Res Cogn. 2019. doi: 10.1016/j.scog.2019.100153.
Affective prosody recognition is associated with role and social functioning in patients with a recent first episode of schizophrenia, according to Kelsey A. Bonfils, PhD, and associates.
The investigators conducted an analysis of 49 patients aged between 18 and 45 years with a recent first episode of schizophrenia who were participating in a larger randomized, controlled trial. Symptoms of schizophrenia were assessed using a 24-item version of the Brief Psychiatric Rating Scale (BPRS) and functioning was assessed using the Global Functioning Scale (GFS) and Role Functioning Scale (RFS). Study participants took the Prosody Task, which assessed the ability to recognize happiness, sadness, anger, fear, and disgust, and the Facial Emotion Identification Test (FEIT), which assesses the ability to recognize happiness, sadness, anger, fear, surprise, and disgust, reported Dr. Bonfils of the Veterans Affairs Pittsburgh Healthcare System and the department of psychiatry at the University of Pittsburgh. The study was published in Schizophrenia Research: Cognition.
In the Prosody Task, patients were significantly more likely to recognize anger (45.6% correct) and sadness (43.8%), and significantly less likely to recognize disgust (21.9%). In the FEIT, patients were most likely to recognize happiness (97.5%), followed by surprise (90.0%), anger (85.0%), sadness (77.5%), disgust (73.8%), and fear (55.0%).
Performance in the Prosody Task was associated with GFS role functioning and RFS social functioning, while FEIT performance was not significantly associated with any functioning measure. In terms of symptoms, Prosody Task performance was negatively associated with disorganization in the BPRS, and FEIT performance was associated with disorganization, reality distortion, and positive symptoms.
“These findings are consistent with the view that emotion recognition deficits could be contributing to deficits in the ability of people with first-episode schizophrenia to adequately function in the real world, both in relationships with friends and in normative young adult roles,” the investigators wrote.
Dr. Bonfils reported no conflicts of interest. Three coauthors reported receiving support, research grants, and funding from several pharmaceutical companies.
SOURCE: Bonfils KA et al. Schizophr Res Cogn. 2019. doi: 10.1016/j.scog.2019.100153.
Affective prosody recognition is associated with role and social functioning in patients with a recent first episode of schizophrenia, according to Kelsey A. Bonfils, PhD, and associates.
The investigators conducted an analysis of 49 patients aged between 18 and 45 years with a recent first episode of schizophrenia who were participating in a larger randomized, controlled trial. Symptoms of schizophrenia were assessed using a 24-item version of the Brief Psychiatric Rating Scale (BPRS) and functioning was assessed using the Global Functioning Scale (GFS) and Role Functioning Scale (RFS). Study participants took the Prosody Task, which assessed the ability to recognize happiness, sadness, anger, fear, and disgust, and the Facial Emotion Identification Test (FEIT), which assesses the ability to recognize happiness, sadness, anger, fear, surprise, and disgust, reported Dr. Bonfils of the Veterans Affairs Pittsburgh Healthcare System and the department of psychiatry at the University of Pittsburgh. The study was published in Schizophrenia Research: Cognition.
In the Prosody Task, patients were significantly more likely to recognize anger (45.6% correct) and sadness (43.8%), and significantly less likely to recognize disgust (21.9%). In the FEIT, patients were most likely to recognize happiness (97.5%), followed by surprise (90.0%), anger (85.0%), sadness (77.5%), disgust (73.8%), and fear (55.0%).
Performance in the Prosody Task was associated with GFS role functioning and RFS social functioning, while FEIT performance was not significantly associated with any functioning measure. In terms of symptoms, Prosody Task performance was negatively associated with disorganization in the BPRS, and FEIT performance was associated with disorganization, reality distortion, and positive symptoms.
“These findings are consistent with the view that emotion recognition deficits could be contributing to deficits in the ability of people with first-episode schizophrenia to adequately function in the real world, both in relationships with friends and in normative young adult roles,” the investigators wrote.
Dr. Bonfils reported no conflicts of interest. Three coauthors reported receiving support, research grants, and funding from several pharmaceutical companies.
SOURCE: Bonfils KA et al. Schizophr Res Cogn. 2019. doi: 10.1016/j.scog.2019.100153.
FROM SCHIZOPHRENIA RESEARCH: COGNITION
Childproofing your protocols, and what’s the deal with airline water?
Childproof your study protocols
Childproof caps on medicine bottles. Like a bank vault lock to third-rate thieves, they’re an impregnable line of defense between inquisitive little hands and heavy-duty pharmaceuticals.
So, you can imagine the delight with which parents learned that their children’s education at an Illinois elementary school included a test of their ability to spring drugs from their fortress-like bottling.
In a quest to advance scientific understanding, a junior high student recruited some of the school’s kindergartners and first graders as participants in a science fair experiment. The hypothesis: “Childproof” medicine bottles were anything but.
The junior high scientist collected data on how quickly the study subjects could defeat assorted bottles. And, being a kindly soul, the adolescent researcher demonstrated techniques for achieving a state of, ahem, pharmaceutical openness.
While teachers were present during the experiment, parental permission slips were not. As any principal or institutional review board knows, informed consent is kind of a big deal.
Surprised parents learned of the experiment only when their kids deftly demonstrated their newfound pill skills. One shocked parent even shared a video of his daughter defeating a childproof lid.
Pharmacies, of course, would remind us all that their bottles are at best “child resistant,” not childproof. It’s a distinction lost on us here at the Bureau of LOTME, however. We’re desperately viewing that how-to video for tips on liberating our statins from the “child resistant” bottle our millennial pharmacist clearly superglued the cap onto.
What’s the deal with airline food?
You probably thought Jerry Seinfeld’s immortal query was rhetorical. No one actually knows what the deal is with airline food, right?
Enter Charles Platkin, PhD, JD, MPH, executive director of the Hunter College NYC Food Policy Center, and editor of DietDetective.com. Not only does he know the deal, he publishes a study detailing the healthiness of the food offered by 11 airlines every year, based on criteria such as healthy nutrients and calorie levels of meals, level of transparency, improvement and maintenance of healthy offerings, and water health.
For the 2018-2019 edition, there’s a tie at the top between Alaska Airlines and Air Canada, both scoring 4 out of 5 on Dr. Platkin’s “Health Score,” both well ahead of Delta and JetBlue in second place with a score of 2.9.
At the bottom? Southwest Airlines, with a paltry 1.7, edging out Spirit and Hawaiian Airlines.
Our personal favorite tidbit from the study has to be the poor scores in water health. Spirit managed to score a measly 1 out of 5 in the water health subscore, and several airlines were below 2. An actual quote from the study: “The quality of drinking water varies by airline, and many have provided passengers with unhealthy water. In general, it’s probably best to avoid drinking coffee and tea on board since they are made with galley water.”
While Hawaiian can take some comfort because they didn’t finish dead last, Dr. Platkin did award them his special “Shame on You” award for not providing all their nutritional information. You can try to hide, Hawaiian Airlines, but Dr. Platkin will find you.
Use the Force, Jack Nicklaus
We here at LOTME usually strive to provide an insightful and up-to-date wrap-up of the latest news on cutting-edge research, clinical breakthroughs, and impolite bodily functions. But right now, we want to talk about something really important: your golf game.
There’s an old saying in golf: Drive for show, putt for dough. That cliché may need a bit of updating, though, now that investigators in Ireland (where they are pretty serious about their golf) have brought science to the party.
Their research indicates that it may be possible for golfers to improve their putting without practicing. Without physically practicing, that is. Without going to the golf course. Just think about it: Golfers can putt better by, you know … just thinking about it.
Imagining the feel of an action without actually performing it is known as kinesthetic imagery ability, and it just might have an effect on putting, researchers from the physical education and sports sciences department at the University of Limerick and Lero, the Science Foundation Ireland Research Centre for Software, reported in Psychology of Sport and Exercise.
In a group of 44 skilled golfers, half watched video of an expert golfer putting in a lab environment “while listening to a motor imagery script consisting of short sentences describing key visual and kinesthetic feelings associated with performing the putting.” Then all the golfers took 40 putts from 15 feet in the lab.
The good kinesthetic imagers in the bunch improved their putting consistency more than subjects with poorer kinesthetic imagery ability and subjects from the nonintervention group.
So, here’s the new and improved old saying for golfers: Drive for show, use your kinesthetic imagery ability for dough. Yup, that’ll definitely catch on.
Childproof your study protocols
Childproof caps on medicine bottles. Like a bank vault lock to third-rate thieves, they’re an impregnable line of defense between inquisitive little hands and heavy-duty pharmaceuticals.
So, you can imagine the delight with which parents learned that their children’s education at an Illinois elementary school included a test of their ability to spring drugs from their fortress-like bottling.
In a quest to advance scientific understanding, a junior high student recruited some of the school’s kindergartners and first graders as participants in a science fair experiment. The hypothesis: “Childproof” medicine bottles were anything but.
The junior high scientist collected data on how quickly the study subjects could defeat assorted bottles. And, being a kindly soul, the adolescent researcher demonstrated techniques for achieving a state of, ahem, pharmaceutical openness.
While teachers were present during the experiment, parental permission slips were not. As any principal or institutional review board knows, informed consent is kind of a big deal.
Surprised parents learned of the experiment only when their kids deftly demonstrated their newfound pill skills. One shocked parent even shared a video of his daughter defeating a childproof lid.
Pharmacies, of course, would remind us all that their bottles are at best “child resistant,” not childproof. It’s a distinction lost on us here at the Bureau of LOTME, however. We’re desperately viewing that how-to video for tips on liberating our statins from the “child resistant” bottle our millennial pharmacist clearly superglued the cap onto.
What’s the deal with airline food?
You probably thought Jerry Seinfeld’s immortal query was rhetorical. No one actually knows what the deal is with airline food, right?
Enter Charles Platkin, PhD, JD, MPH, executive director of the Hunter College NYC Food Policy Center, and editor of DietDetective.com. Not only does he know the deal, he publishes a study detailing the healthiness of the food offered by 11 airlines every year, based on criteria such as healthy nutrients and calorie levels of meals, level of transparency, improvement and maintenance of healthy offerings, and water health.
For the 2018-2019 edition, there’s a tie at the top between Alaska Airlines and Air Canada, both scoring 4 out of 5 on Dr. Platkin’s “Health Score,” both well ahead of Delta and JetBlue in second place with a score of 2.9.
At the bottom? Southwest Airlines, with a paltry 1.7, edging out Spirit and Hawaiian Airlines.
Our personal favorite tidbit from the study has to be the poor scores in water health. Spirit managed to score a measly 1 out of 5 in the water health subscore, and several airlines were below 2. An actual quote from the study: “The quality of drinking water varies by airline, and many have provided passengers with unhealthy water. In general, it’s probably best to avoid drinking coffee and tea on board since they are made with galley water.”
While Hawaiian can take some comfort because they didn’t finish dead last, Dr. Platkin did award them his special “Shame on You” award for not providing all their nutritional information. You can try to hide, Hawaiian Airlines, but Dr. Platkin will find you.
Use the Force, Jack Nicklaus
We here at LOTME usually strive to provide an insightful and up-to-date wrap-up of the latest news on cutting-edge research, clinical breakthroughs, and impolite bodily functions. But right now, we want to talk about something really important: your golf game.
There’s an old saying in golf: Drive for show, putt for dough. That cliché may need a bit of updating, though, now that investigators in Ireland (where they are pretty serious about their golf) have brought science to the party.
Their research indicates that it may be possible for golfers to improve their putting without practicing. Without physically practicing, that is. Without going to the golf course. Just think about it: Golfers can putt better by, you know … just thinking about it.
Imagining the feel of an action without actually performing it is known as kinesthetic imagery ability, and it just might have an effect on putting, researchers from the physical education and sports sciences department at the University of Limerick and Lero, the Science Foundation Ireland Research Centre for Software, reported in Psychology of Sport and Exercise.
In a group of 44 skilled golfers, half watched video of an expert golfer putting in a lab environment “while listening to a motor imagery script consisting of short sentences describing key visual and kinesthetic feelings associated with performing the putting.” Then all the golfers took 40 putts from 15 feet in the lab.
The good kinesthetic imagers in the bunch improved their putting consistency more than subjects with poorer kinesthetic imagery ability and subjects from the nonintervention group.
So, here’s the new and improved old saying for golfers: Drive for show, use your kinesthetic imagery ability for dough. Yup, that’ll definitely catch on.
Childproof your study protocols
Childproof caps on medicine bottles. Like a bank vault lock to third-rate thieves, they’re an impregnable line of defense between inquisitive little hands and heavy-duty pharmaceuticals.
So, you can imagine the delight with which parents learned that their children’s education at an Illinois elementary school included a test of their ability to spring drugs from their fortress-like bottling.
In a quest to advance scientific understanding, a junior high student recruited some of the school’s kindergartners and first graders as participants in a science fair experiment. The hypothesis: “Childproof” medicine bottles were anything but.
The junior high scientist collected data on how quickly the study subjects could defeat assorted bottles. And, being a kindly soul, the adolescent researcher demonstrated techniques for achieving a state of, ahem, pharmaceutical openness.
While teachers were present during the experiment, parental permission slips were not. As any principal or institutional review board knows, informed consent is kind of a big deal.
Surprised parents learned of the experiment only when their kids deftly demonstrated their newfound pill skills. One shocked parent even shared a video of his daughter defeating a childproof lid.
Pharmacies, of course, would remind us all that their bottles are at best “child resistant,” not childproof. It’s a distinction lost on us here at the Bureau of LOTME, however. We’re desperately viewing that how-to video for tips on liberating our statins from the “child resistant” bottle our millennial pharmacist clearly superglued the cap onto.
What’s the deal with airline food?
You probably thought Jerry Seinfeld’s immortal query was rhetorical. No one actually knows what the deal is with airline food, right?
Enter Charles Platkin, PhD, JD, MPH, executive director of the Hunter College NYC Food Policy Center, and editor of DietDetective.com. Not only does he know the deal, he publishes a study detailing the healthiness of the food offered by 11 airlines every year, based on criteria such as healthy nutrients and calorie levels of meals, level of transparency, improvement and maintenance of healthy offerings, and water health.
For the 2018-2019 edition, there’s a tie at the top between Alaska Airlines and Air Canada, both scoring 4 out of 5 on Dr. Platkin’s “Health Score,” both well ahead of Delta and JetBlue in second place with a score of 2.9.
At the bottom? Southwest Airlines, with a paltry 1.7, edging out Spirit and Hawaiian Airlines.
Our personal favorite tidbit from the study has to be the poor scores in water health. Spirit managed to score a measly 1 out of 5 in the water health subscore, and several airlines were below 2. An actual quote from the study: “The quality of drinking water varies by airline, and many have provided passengers with unhealthy water. In general, it’s probably best to avoid drinking coffee and tea on board since they are made with galley water.”
While Hawaiian can take some comfort because they didn’t finish dead last, Dr. Platkin did award them his special “Shame on You” award for not providing all their nutritional information. You can try to hide, Hawaiian Airlines, but Dr. Platkin will find you.
Use the Force, Jack Nicklaus
We here at LOTME usually strive to provide an insightful and up-to-date wrap-up of the latest news on cutting-edge research, clinical breakthroughs, and impolite bodily functions. But right now, we want to talk about something really important: your golf game.
There’s an old saying in golf: Drive for show, putt for dough. That cliché may need a bit of updating, though, now that investigators in Ireland (where they are pretty serious about their golf) have brought science to the party.
Their research indicates that it may be possible for golfers to improve their putting without practicing. Without physically practicing, that is. Without going to the golf course. Just think about it: Golfers can putt better by, you know … just thinking about it.
Imagining the feel of an action without actually performing it is known as kinesthetic imagery ability, and it just might have an effect on putting, researchers from the physical education and sports sciences department at the University of Limerick and Lero, the Science Foundation Ireland Research Centre for Software, reported in Psychology of Sport and Exercise.
In a group of 44 skilled golfers, half watched video of an expert golfer putting in a lab environment “while listening to a motor imagery script consisting of short sentences describing key visual and kinesthetic feelings associated with performing the putting.” Then all the golfers took 40 putts from 15 feet in the lab.
The good kinesthetic imagers in the bunch improved their putting consistency more than subjects with poorer kinesthetic imagery ability and subjects from the nonintervention group.
So, here’s the new and improved old saying for golfers: Drive for show, use your kinesthetic imagery ability for dough. Yup, that’ll definitely catch on.
High recurrence, shortening cycle length in bipolar disorder associated with several biomarkers
Several potential biomarkers may indicate whether patients with bipolar disorder may have high-recurrence disease with a cycle length that progressively shortens, according to Erik Smedler, MD, PhD, of the department of psychiatry and neurochemistry at Gothenburg (Sweden) University.
For the analysis, published in European Neuropsychopharmacology, A total of 745 patients had serum samples available; assays for 203 different protein biomarkers were performed on those samples.
The investigators clustered patients according to frequency – with low-frequency recurrence defined as a maximum of one inpatient episode per year – and by cycle length – with sensitized patients having progressively shorter periods between inpatient episodes. No difference in biomarkers or clinical features were seen between high- and low-frequency recurrence patients, but sensitized patients were significantly more ill and were more likely to be treated with antidepressants.
In addition, in a specific cohort of patients who were both sensitized and had a high recurrence rate (at least five inpatient episodes), four proteins were expressed at a significantly lower level than that of nonsensitized patients: tumor necrosis factor receptor-2, tumor necrosis factor receptor superfamily member 4, placenta growth factor, and adrenomedullin. Sensitization also was associated with a single nucleotide polymorphism near the calcium channel gene CACNA2D3.
“These results suggest the potential for translational research aimed at preventive actions,” the investigators wrote.
The authors reported that they had no conflicts of interest.
SOURCE: Smedler E et al. Eur Neuropsychopharmacol. 2019 Aug 1. doi: 10.1016/j.euroneuro.2019.07.132.
Several potential biomarkers may indicate whether patients with bipolar disorder may have high-recurrence disease with a cycle length that progressively shortens, according to Erik Smedler, MD, PhD, of the department of psychiatry and neurochemistry at Gothenburg (Sweden) University.
For the analysis, published in European Neuropsychopharmacology, A total of 745 patients had serum samples available; assays for 203 different protein biomarkers were performed on those samples.
The investigators clustered patients according to frequency – with low-frequency recurrence defined as a maximum of one inpatient episode per year – and by cycle length – with sensitized patients having progressively shorter periods between inpatient episodes. No difference in biomarkers or clinical features were seen between high- and low-frequency recurrence patients, but sensitized patients were significantly more ill and were more likely to be treated with antidepressants.
In addition, in a specific cohort of patients who were both sensitized and had a high recurrence rate (at least five inpatient episodes), four proteins were expressed at a significantly lower level than that of nonsensitized patients: tumor necrosis factor receptor-2, tumor necrosis factor receptor superfamily member 4, placenta growth factor, and adrenomedullin. Sensitization also was associated with a single nucleotide polymorphism near the calcium channel gene CACNA2D3.
“These results suggest the potential for translational research aimed at preventive actions,” the investigators wrote.
The authors reported that they had no conflicts of interest.
SOURCE: Smedler E et al. Eur Neuropsychopharmacol. 2019 Aug 1. doi: 10.1016/j.euroneuro.2019.07.132.
Several potential biomarkers may indicate whether patients with bipolar disorder may have high-recurrence disease with a cycle length that progressively shortens, according to Erik Smedler, MD, PhD, of the department of psychiatry and neurochemistry at Gothenburg (Sweden) University.
For the analysis, published in European Neuropsychopharmacology, A total of 745 patients had serum samples available; assays for 203 different protein biomarkers were performed on those samples.
The investigators clustered patients according to frequency – with low-frequency recurrence defined as a maximum of one inpatient episode per year – and by cycle length – with sensitized patients having progressively shorter periods between inpatient episodes. No difference in biomarkers or clinical features were seen between high- and low-frequency recurrence patients, but sensitized patients were significantly more ill and were more likely to be treated with antidepressants.
In addition, in a specific cohort of patients who were both sensitized and had a high recurrence rate (at least five inpatient episodes), four proteins were expressed at a significantly lower level than that of nonsensitized patients: tumor necrosis factor receptor-2, tumor necrosis factor receptor superfamily member 4, placenta growth factor, and adrenomedullin. Sensitization also was associated with a single nucleotide polymorphism near the calcium channel gene CACNA2D3.
“These results suggest the potential for translational research aimed at preventive actions,” the investigators wrote.
The authors reported that they had no conflicts of interest.
SOURCE: Smedler E et al. Eur Neuropsychopharmacol. 2019 Aug 1. doi: 10.1016/j.euroneuro.2019.07.132.
FROM EUROPEAN NEUROPSYCHOPHARMACOLOGY
FDA approves Oxbryta for sickle cell disease treatment
The Food and Drug Administration has approved voxelotor (Oxbryta) for adults and pediatric patients aged 12 years and older with sickle cell disease.
Approval was based on results from HOPE, a randomized, double-blind, placebo-controlled, multicenter trial of 274 patients with sickle cell disease (median age, 24 years) with a baseline hemoglobin level between 5.5 and 10.5 g/dL. Just over half of patients (51.1%) who received voxelotor at 1,500 mg had a hemoglobin increase of at least 1 g/dL over the 24-week study period, compared with 6.5% of patients who received placebo.
Patients in the 1,500-mg group also had reduced indirect bilirubin and percent reticulocyte count at –29.1% and –19.9%, respectively, compared with placebo, where the change was –3.2% and 4.5%, respectively.
The most common adverse events associated with voxelotor are headache, diarrhea, abdominal pain, nausea, rash, fatigue and pyrexia. The recommended voxelotor dose is 1,500 mg orally once daily with or without food, according to the FDA.
The Food and Drug Administration has approved voxelotor (Oxbryta) for adults and pediatric patients aged 12 years and older with sickle cell disease.
Approval was based on results from HOPE, a randomized, double-blind, placebo-controlled, multicenter trial of 274 patients with sickle cell disease (median age, 24 years) with a baseline hemoglobin level between 5.5 and 10.5 g/dL. Just over half of patients (51.1%) who received voxelotor at 1,500 mg had a hemoglobin increase of at least 1 g/dL over the 24-week study period, compared with 6.5% of patients who received placebo.
Patients in the 1,500-mg group also had reduced indirect bilirubin and percent reticulocyte count at –29.1% and –19.9%, respectively, compared with placebo, where the change was –3.2% and 4.5%, respectively.
The most common adverse events associated with voxelotor are headache, diarrhea, abdominal pain, nausea, rash, fatigue and pyrexia. The recommended voxelotor dose is 1,500 mg orally once daily with or without food, according to the FDA.
The Food and Drug Administration has approved voxelotor (Oxbryta) for adults and pediatric patients aged 12 years and older with sickle cell disease.
Approval was based on results from HOPE, a randomized, double-blind, placebo-controlled, multicenter trial of 274 patients with sickle cell disease (median age, 24 years) with a baseline hemoglobin level between 5.5 and 10.5 g/dL. Just over half of patients (51.1%) who received voxelotor at 1,500 mg had a hemoglobin increase of at least 1 g/dL over the 24-week study period, compared with 6.5% of patients who received placebo.
Patients in the 1,500-mg group also had reduced indirect bilirubin and percent reticulocyte count at –29.1% and –19.9%, respectively, compared with placebo, where the change was –3.2% and 4.5%, respectively.
The most common adverse events associated with voxelotor are headache, diarrhea, abdominal pain, nausea, rash, fatigue and pyrexia. The recommended voxelotor dose is 1,500 mg orally once daily with or without food, according to the FDA.
Alkermes submits NDA for new schizophrenia, bipolar I treatment
Alkermes has announced that it has submitted a New Drug Application to the Food and Drug Administration for the approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder.
Included in the application for the investigational, novel, once-daily, oral atypical antipsychotic drug candidate is data from the ENLIGHTEN-1 study, which evaluated the antipsychotic efficacy of ALKS 3831, compared with a placebo, over a 4-week period, as well as data from ENLIGHTEN-2, which compared weight gain with ALKS 3831 and olanzapine alone over a 6-month period.
“Antipsychotic medications are an important part of the treatment paradigm for both schizophrenia and bipolar I disorder, yet there remains a persistent unmet need for new treatments,” Craig Hopkinson, MD, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes, said in a press release.
As a combination of olanzapine and samidorphan, Samidorphan, an opioid receptor antagonist, is structurally related to naltrexone.
Alkermes is seeking an indication for the treatment of schizophrenia and an indication for the treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy or as an adjunct to lithium or valproate, as well as for maintenance treatment of bipolar I. Dosage strength would be 10 mg of samidorphan with 5, 10, 15, or 20 mg of olanzapine.
Find the full press release on the Alkermes website.
Alkermes has announced that it has submitted a New Drug Application to the Food and Drug Administration for the approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder.
Included in the application for the investigational, novel, once-daily, oral atypical antipsychotic drug candidate is data from the ENLIGHTEN-1 study, which evaluated the antipsychotic efficacy of ALKS 3831, compared with a placebo, over a 4-week period, as well as data from ENLIGHTEN-2, which compared weight gain with ALKS 3831 and olanzapine alone over a 6-month period.
“Antipsychotic medications are an important part of the treatment paradigm for both schizophrenia and bipolar I disorder, yet there remains a persistent unmet need for new treatments,” Craig Hopkinson, MD, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes, said in a press release.
As a combination of olanzapine and samidorphan, Samidorphan, an opioid receptor antagonist, is structurally related to naltrexone.
Alkermes is seeking an indication for the treatment of schizophrenia and an indication for the treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy or as an adjunct to lithium or valproate, as well as for maintenance treatment of bipolar I. Dosage strength would be 10 mg of samidorphan with 5, 10, 15, or 20 mg of olanzapine.
Find the full press release on the Alkermes website.
Alkermes has announced that it has submitted a New Drug Application to the Food and Drug Administration for the approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder.
Included in the application for the investigational, novel, once-daily, oral atypical antipsychotic drug candidate is data from the ENLIGHTEN-1 study, which evaluated the antipsychotic efficacy of ALKS 3831, compared with a placebo, over a 4-week period, as well as data from ENLIGHTEN-2, which compared weight gain with ALKS 3831 and olanzapine alone over a 6-month period.
“Antipsychotic medications are an important part of the treatment paradigm for both schizophrenia and bipolar I disorder, yet there remains a persistent unmet need for new treatments,” Craig Hopkinson, MD, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes, said in a press release.
As a combination of olanzapine and samidorphan, Samidorphan, an opioid receptor antagonist, is structurally related to naltrexone.
Alkermes is seeking an indication for the treatment of schizophrenia and an indication for the treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy or as an adjunct to lithium or valproate, as well as for maintenance treatment of bipolar I. Dosage strength would be 10 mg of samidorphan with 5, 10, 15, or 20 mg of olanzapine.
Find the full press release on the Alkermes website.
FDA: Two repackagers issue voluntary ranitidine recall
The ranitidine recall saga continues as two more companies have issued voluntary recalls of their repackaged ranitidine products because of possibly unacceptable levels of N-nitrosodimethylamine (NDMA), according to the Food and Drug Administration.
Golden State Medical Supply has recalled 150-mg and 300-mg ranitidine capsules, manufactured by Novitium, and Precision Dose has recalled a ranitidine oral solution at 150 mg/mL, manufactured by Amneal Pharmaceuticals.
“FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 ng/day or 0.32 parts per million for ranitidine),” the FDA said. The agency has “posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.”
The FDA added that consumers taking over-the-counter ranitidine can consider alternatives such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), and omeprazole (Prilosec).
Find the full press release and more information on other ranitidine recalls on the FDA website.
The ranitidine recall saga continues as two more companies have issued voluntary recalls of their repackaged ranitidine products because of possibly unacceptable levels of N-nitrosodimethylamine (NDMA), according to the Food and Drug Administration.
Golden State Medical Supply has recalled 150-mg and 300-mg ranitidine capsules, manufactured by Novitium, and Precision Dose has recalled a ranitidine oral solution at 150 mg/mL, manufactured by Amneal Pharmaceuticals.
“FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 ng/day or 0.32 parts per million for ranitidine),” the FDA said. The agency has “posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.”
The FDA added that consumers taking over-the-counter ranitidine can consider alternatives such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), and omeprazole (Prilosec).
Find the full press release and more information on other ranitidine recalls on the FDA website.
The ranitidine recall saga continues as two more companies have issued voluntary recalls of their repackaged ranitidine products because of possibly unacceptable levels of N-nitrosodimethylamine (NDMA), according to the Food and Drug Administration.
Golden State Medical Supply has recalled 150-mg and 300-mg ranitidine capsules, manufactured by Novitium, and Precision Dose has recalled a ranitidine oral solution at 150 mg/mL, manufactured by Amneal Pharmaceuticals.
“FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 ng/day or 0.32 parts per million for ranitidine),” the FDA said. The agency has “posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.”
The FDA added that consumers taking over-the-counter ranitidine can consider alternatives such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), and omeprazole (Prilosec).
Find the full press release and more information on other ranitidine recalls on the FDA website.
FDA approves acalabrutinib for CLL, SLL treatment
The Food and Drug Administration has approved acalabrutinib (Calquence) as initial or subsequent treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
The approval came as part of Project Orbis, a collaboration among the FDA, the Australian Therapeutic Goods Administration, and Health Canada. The program allows for the concurrent submission of review of oncology drug applications among the various agencies.
Acalabrutinib, a bruton tyrosin kinase inhibitor, is already approved in the United States for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. The FDA granted breakthrough therapy designation to acalabrutinib as a monotherapy for adults with CLL in August 2019, allowing for an expedited review.
The approval in CLL/SLL was based on results from two randomized clinical trials comparing acalabrutinib with other standard treatments. In the first trial, patients with previously untreated CLL who received acalabrutinib had a longer progression-free survival time, compared with patients who received standard treatment. A similar result was seen in the second trial among patients with previously treated CLL.
The most common adverse events associated with acalabrutinib include anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain. Patients receiving the drug should be monitored for symptoms of arrhythmia, serious infection, bleeding, and low blood count. Full prescribing information can be found on the FDA website.
The Food and Drug Administration has approved acalabrutinib (Calquence) as initial or subsequent treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
The approval came as part of Project Orbis, a collaboration among the FDA, the Australian Therapeutic Goods Administration, and Health Canada. The program allows for the concurrent submission of review of oncology drug applications among the various agencies.
Acalabrutinib, a bruton tyrosin kinase inhibitor, is already approved in the United States for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. The FDA granted breakthrough therapy designation to acalabrutinib as a monotherapy for adults with CLL in August 2019, allowing for an expedited review.
The approval in CLL/SLL was based on results from two randomized clinical trials comparing acalabrutinib with other standard treatments. In the first trial, patients with previously untreated CLL who received acalabrutinib had a longer progression-free survival time, compared with patients who received standard treatment. A similar result was seen in the second trial among patients with previously treated CLL.
The most common adverse events associated with acalabrutinib include anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain. Patients receiving the drug should be monitored for symptoms of arrhythmia, serious infection, bleeding, and low blood count. Full prescribing information can be found on the FDA website.
The Food and Drug Administration has approved acalabrutinib (Calquence) as initial or subsequent treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
The approval came as part of Project Orbis, a collaboration among the FDA, the Australian Therapeutic Goods Administration, and Health Canada. The program allows for the concurrent submission of review of oncology drug applications among the various agencies.
Acalabrutinib, a bruton tyrosin kinase inhibitor, is already approved in the United States for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. The FDA granted breakthrough therapy designation to acalabrutinib as a monotherapy for adults with CLL in August 2019, allowing for an expedited review.
The approval in CLL/SLL was based on results from two randomized clinical trials comparing acalabrutinib with other standard treatments. In the first trial, patients with previously untreated CLL who received acalabrutinib had a longer progression-free survival time, compared with patients who received standard treatment. A similar result was seen in the second trial among patients with previously treated CLL.
The most common adverse events associated with acalabrutinib include anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain. Patients receiving the drug should be monitored for symptoms of arrhythmia, serious infection, bleeding, and low blood count. Full prescribing information can be found on the FDA website.