Mixed Topics

The US Food and Drug Administration (FDA) has granted accelerated approval to pirtobrutinib (Jaypirca; Eli Lilly and Company) for third-line or later treatment in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who previously received a Bruton tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

The agent was initially approved in January 2023 for patients with mantle cell lymphoma who had previously received a BTK inhibitor.

Like the mantle cell approval, the CLL/SLL approval was based on findings from the open-label, single-arm, phase 1/2 BRUIN study that included adults with at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

The trial included 108 patients with either CLL or SLL. Overall, patients demonstrated an overall response rate of 72%, all of which were partial responses, and median duration of response of 12.2 months.

Before starting pirtobrutinib, 77% of patients with CLL or SLL had discontinued their last BTK inhibitor for refractory or progressive disease.

“Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be poor, making the approval of Jaypirca a meaningful advance and much-needed new treatment option for these patients,” William G. Wierda, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, said in an Eli Lilly press release. 

Treatment during the study included the recommended dose of 200 mg given orally once daily until disease progression or unacceptable toxicity. Common adverse reactions that occurred in at least 20% of patients included fatigue, bruising, cough, musculoskeletal pain, COVID-19, diarrhea, pneumonia, abdominal pain, dyspnea, hemorrhage, edema, nausea, pyrexia, and headache. Grade 3 or 4 laboratory abnormalities occurring in more than 10% of patients included decreased neutrophil counts, anemia, and decreased platelet counts.

Serious infections occurred in 32% of patients, including fatal infections in 10% of patients. The prescribing information for pirtobrutinib includes warnings about infections, hemorrhage, cytopenias, cardiac arrhythmias, and secondary primary malignancies.

A version of this article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has granted accelerated approval to pirtobrutinib (Jaypirca; Eli Lilly and Company) for third-line or later treatment in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who previously received a Bruton tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

The agent was initially approved in January 2023 for patients with mantle cell lymphoma who had previously received a BTK inhibitor.

Like the mantle cell approval, the CLL/SLL approval was based on findings from the open-label, single-arm, phase 1/2 BRUIN study that included adults with at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

The trial included 108 patients with either CLL or SLL. Overall, patients demonstrated an overall response rate of 72%, all of which were partial responses, and median duration of response of 12.2 months.

Before starting pirtobrutinib, 77% of patients with CLL or SLL had discontinued their last BTK inhibitor for refractory or progressive disease.

“Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be poor, making the approval of Jaypirca a meaningful advance and much-needed new treatment option for these patients,” William G. Wierda, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, said in an Eli Lilly press release. 

Treatment during the study included the recommended dose of 200 mg given orally once daily until disease progression or unacceptable toxicity. Common adverse reactions that occurred in at least 20% of patients included fatigue, bruising, cough, musculoskeletal pain, COVID-19, diarrhea, pneumonia, abdominal pain, dyspnea, hemorrhage, edema, nausea, pyrexia, and headache. Grade 3 or 4 laboratory abnormalities occurring in more than 10% of patients included decreased neutrophil counts, anemia, and decreased platelet counts.

Serious infections occurred in 32% of patients, including fatal infections in 10% of patients. The prescribing information for pirtobrutinib includes warnings about infections, hemorrhage, cytopenias, cardiac arrhythmias, and secondary primary malignancies.

A version of this article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has granted accelerated approval to pirtobrutinib (Jaypirca; Eli Lilly and Company) for third-line or later treatment in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who previously received a Bruton tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

The agent was initially approved in January 2023 for patients with mantle cell lymphoma who had previously received a BTK inhibitor.

Like the mantle cell approval, the CLL/SLL approval was based on findings from the open-label, single-arm, phase 1/2 BRUIN study that included adults with at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

The trial included 108 patients with either CLL or SLL. Overall, patients demonstrated an overall response rate of 72%, all of which were partial responses, and median duration of response of 12.2 months.

Before starting pirtobrutinib, 77% of patients with CLL or SLL had discontinued their last BTK inhibitor for refractory or progressive disease.

“Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be poor, making the approval of Jaypirca a meaningful advance and much-needed new treatment option for these patients,” William G. Wierda, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, said in an Eli Lilly press release. 

Treatment during the study included the recommended dose of 200 mg given orally once daily until disease progression or unacceptable toxicity. Common adverse reactions that occurred in at least 20% of patients included fatigue, bruising, cough, musculoskeletal pain, COVID-19, diarrhea, pneumonia, abdominal pain, dyspnea, hemorrhage, edema, nausea, pyrexia, and headache. Grade 3 or 4 laboratory abnormalities occurring in more than 10% of patients included decreased neutrophil counts, anemia, and decreased platelet counts.

Serious infections occurred in 32% of patients, including fatal infections in 10% of patients. The prescribing information for pirtobrutinib includes warnings about infections, hemorrhage, cytopenias, cardiac arrhythmias, and secondary primary malignancies.

A version of this article first appeared on Medscape.com.

In 2021, when Eric Esrailian, MD, MPH, was awarded the Benemerenti Medal from Pope Francis for his humanitarian work, he recognized other people worldwide who save lives daily – but without recognition. They’re motivated for “the right reasons. To be clear, I do not deserve this honor. It is honestly overwhelming and humbling,” he said in 2021 when news of the award reached him in Los Angeles where he holds the Lincy Foundation Chair in Clinical Gastroenterology at the University of California, Los Angeles. He also serves as chief of the Vatche and Tamar Manoukian Division of Digestive Diseases, and director of the Melvin and Bren Simon Digestive Diseases Center.

Courtesy Dr. Eric Esrailian

Dr. Esrailian, the son of Armenian immigrants, says that humanitarian work has been ingrained in him since childhood. His great-grandparents were Armenian genocide survivors and their struggles have never left him. He’s devoted his life not only to medicine, but to documenting the history of the Armenian genocide and leading, or supporting, efforts to resolve humanitarian crises in Armenia and around the world. Earlier this year, he, with Kim Kardashian and singer/actor Cher, published op-eds that addressed a humanitarian crisis building as a result of Azerbaijan’s blockade of the Lachin corridor – which is the only road that links Armenia to the ethnic Armenian–populated sections of Nagorno-Karabakh. In September, Armenia and Azerbaijan reached a tentative agreement to end the blockade, but more needs to be done, he says. Tragedies continue to unfold, and he is redoubling his efforts to bring more attention to this humanitarian crisis, he said.

Because storytelling is an important part of raising awareness, in 2016 Dr. Esrailian and partners produced two films about stories of perseverance, endurance, and the inextinguishable fire of the human spirit. The first film was “The Promise,” a historical war drama set in the Ottoman Empire and released in 2016. In 2017, he and partners released “Intent to Destroy: Death, Denial, & Depiction,” a documentary about the Armenian genocide. The documentary received an Emmy nomination for Outstanding Historical Documentary. And, in 2020, he produced “Francesco,” a film about Pope Francis that documented his pilgrimage to Armenia in 2016.

“The Promise” had such an impact on viewers that in 2017 Dr. Esrailian and the UCLA School of Law created The Promise Institute for Human Rights as a center of human rights education, research, and advocacy. In 2019, Dr. Esrailian and UCLA followed up with The Promise Armenian Institute as a place for academic research and teaching of Armenian studies, language, and culture. “The impact from building these two institutes has been transformational, and they will be part of UCLA forever,” he said.

His philanthropic efforts connecting health, human rights, education, and the arts has had an impact worldwide. One person can make a difference, Dr. Esrailian said: “I’ve learned along the way that an individual can have more of an impact than ever imagined, but you have to dream big and never give up.”

In this interview, he tells us more about his work.
 

Q: Not many doctors wear hats in medicine and filmmaking. Describe your journey as a filmmaker.

Dr. Esrailian: I’ve always been interested in storytelling. I was an English minor at Berkeley. My late mentor, Kirk Kerkorian, a legendary philanthropist, businessman, and entrepreneur, pushed me to take storytelling and do something that would potentially help secure Armenian Genocide recognition by the United States. Because of genocide denialists and geopolitical pressure, he felt the United States government was reluctant to recognize the Armenian Genocide. He thought having some visual materials for educational and outreach efforts would be transformational, and as it turns out, they were.

If you talk to any advocacy organization that tried for years to get Armenian Genocide recognition, they’d say that both films, “The Promise” (a feature film) and “Intent to Destroy” (a documentary), and the social impact media campaign we launched around them, were influential in moving the needle with legislators in the United States who, 3 years after “The Promise” was released, recognized the genocide. This was followed by the Library of Congress in 2020 and President Biden’s executive branch in 2021.
 

Q: What has been your most rewarding accomplishment?

Dr. Esrailian: Giving a voice to people who don’t have a voice is something that I’m proud of. Sometimes, it’s questionable what impact it may have because we still see atrocities committed all over the world. In September, Azerbaijan completed an ethnic cleansing campaign of Armenians from a region called Artsakh, officially the Republic of Nagorno-Karabakh.

Despite having so many relationships with powerful people in government and in high-profile media, and despite our documentaries, op-eds, and interactions with influential leaders on a regular basis, it always feels like it’s not enough. Obviously, the perpetrators are still able to abuse human rights and conduct these campaigns. Nevertheless, I don’t think we should be deterred. Allowing human rights violations to occur with impunity only emboldens perpetrators even more. It takes a long time to bring people to justice through international courts, but it does happen – eventually. That’s something I’m going to continue to work on.
 

Q: What should be the role of physicians in supporting human rights?

Dr. Esrailian: Physicians and health care providers play an important role in human rights. If you look back throughout history, whether it’s the International Committee of the Red Cross, or Doctors Without Borders, or other organizations, physicians and health care professionals are often on the front lines, helping people. Unfortunately, physicians have also been part of human rights violations, like the Holocaust or other genocides. But I do think that in this day and age, with the reputation that physicians have, we can be policy advocates and upstanders in addition to taking care of patients. Telling our stories to the world is important so that people know what’s actually happening on the ground.

Lightning round

Do you prefer texting or talking?  
Talking

How many cups of coffee do you drink each day?
Two

What was the last movie you watched?
Mission Impossible

If you weren’t a gastroenterologist, what would you be?  
Entrepreneur

Who inspires you?  
My family

In 2021, when Eric Esrailian, MD, MPH, was awarded the Benemerenti Medal from Pope Francis for his humanitarian work, he recognized other people worldwide who save lives daily – but without recognition. They’re motivated for “the right reasons. To be clear, I do not deserve this honor. It is honestly overwhelming and humbling,” he said in 2021 when news of the award reached him in Los Angeles where he holds the Lincy Foundation Chair in Clinical Gastroenterology at the University of California, Los Angeles. He also serves as chief of the Vatche and Tamar Manoukian Division of Digestive Diseases, and director of the Melvin and Bren Simon Digestive Diseases Center.

Courtesy Dr. Eric Esrailian

Dr. Esrailian, the son of Armenian immigrants, says that humanitarian work has been ingrained in him since childhood. His great-grandparents were Armenian genocide survivors and their struggles have never left him. He’s devoted his life not only to medicine, but to documenting the history of the Armenian genocide and leading, or supporting, efforts to resolve humanitarian crises in Armenia and around the world. Earlier this year, he, with Kim Kardashian and singer/actor Cher, published op-eds that addressed a humanitarian crisis building as a result of Azerbaijan’s blockade of the Lachin corridor – which is the only road that links Armenia to the ethnic Armenian–populated sections of Nagorno-Karabakh. In September, Armenia and Azerbaijan reached a tentative agreement to end the blockade, but more needs to be done, he says. Tragedies continue to unfold, and he is redoubling his efforts to bring more attention to this humanitarian crisis, he said.

Because storytelling is an important part of raising awareness, in 2016 Dr. Esrailian and partners produced two films about stories of perseverance, endurance, and the inextinguishable fire of the human spirit. The first film was “The Promise,” a historical war drama set in the Ottoman Empire and released in 2016. In 2017, he and partners released “Intent to Destroy: Death, Denial, & Depiction,” a documentary about the Armenian genocide. The documentary received an Emmy nomination for Outstanding Historical Documentary. And, in 2020, he produced “Francesco,” a film about Pope Francis that documented his pilgrimage to Armenia in 2016.

“The Promise” had such an impact on viewers that in 2017 Dr. Esrailian and the UCLA School of Law created The Promise Institute for Human Rights as a center of human rights education, research, and advocacy. In 2019, Dr. Esrailian and UCLA followed up with The Promise Armenian Institute as a place for academic research and teaching of Armenian studies, language, and culture. “The impact from building these two institutes has been transformational, and they will be part of UCLA forever,” he said.

His philanthropic efforts connecting health, human rights, education, and the arts has had an impact worldwide. One person can make a difference, Dr. Esrailian said: “I’ve learned along the way that an individual can have more of an impact than ever imagined, but you have to dream big and never give up.”

In this interview, he tells us more about his work.
 

Q: Not many doctors wear hats in medicine and filmmaking. Describe your journey as a filmmaker.

Dr. Esrailian: I’ve always been interested in storytelling. I was an English minor at Berkeley. My late mentor, Kirk Kerkorian, a legendary philanthropist, businessman, and entrepreneur, pushed me to take storytelling and do something that would potentially help secure Armenian Genocide recognition by the United States. Because of genocide denialists and geopolitical pressure, he felt the United States government was reluctant to recognize the Armenian Genocide. He thought having some visual materials for educational and outreach efforts would be transformational, and as it turns out, they were.

If you talk to any advocacy organization that tried for years to get Armenian Genocide recognition, they’d say that both films, “The Promise” (a feature film) and “Intent to Destroy” (a documentary), and the social impact media campaign we launched around them, were influential in moving the needle with legislators in the United States who, 3 years after “The Promise” was released, recognized the genocide. This was followed by the Library of Congress in 2020 and President Biden’s executive branch in 2021.
 

Q: What has been your most rewarding accomplishment?

Dr. Esrailian: Giving a voice to people who don’t have a voice is something that I’m proud of. Sometimes, it’s questionable what impact it may have because we still see atrocities committed all over the world. In September, Azerbaijan completed an ethnic cleansing campaign of Armenians from a region called Artsakh, officially the Republic of Nagorno-Karabakh.

Despite having so many relationships with powerful people in government and in high-profile media, and despite our documentaries, op-eds, and interactions with influential leaders on a regular basis, it always feels like it’s not enough. Obviously, the perpetrators are still able to abuse human rights and conduct these campaigns. Nevertheless, I don’t think we should be deterred. Allowing human rights violations to occur with impunity only emboldens perpetrators even more. It takes a long time to bring people to justice through international courts, but it does happen – eventually. That’s something I’m going to continue to work on.
 

Q: What should be the role of physicians in supporting human rights?

Dr. Esrailian: Physicians and health care providers play an important role in human rights. If you look back throughout history, whether it’s the International Committee of the Red Cross, or Doctors Without Borders, or other organizations, physicians and health care professionals are often on the front lines, helping people. Unfortunately, physicians have also been part of human rights violations, like the Holocaust or other genocides. But I do think that in this day and age, with the reputation that physicians have, we can be policy advocates and upstanders in addition to taking care of patients. Telling our stories to the world is important so that people know what’s actually happening on the ground.

Lightning round

Do you prefer texting or talking?  
Talking

How many cups of coffee do you drink each day?
Two

What was the last movie you watched?
Mission Impossible

If you weren’t a gastroenterologist, what would you be?  
Entrepreneur

Who inspires you?  
My family

In 2021, when Eric Esrailian, MD, MPH, was awarded the Benemerenti Medal from Pope Francis for his humanitarian work, he recognized other people worldwide who save lives daily – but without recognition. They’re motivated for “the right reasons. To be clear, I do not deserve this honor. It is honestly overwhelming and humbling,” he said in 2021 when news of the award reached him in Los Angeles where he holds the Lincy Foundation Chair in Clinical Gastroenterology at the University of California, Los Angeles. He also serves as chief of the Vatche and Tamar Manoukian Division of Digestive Diseases, and director of the Melvin and Bren Simon Digestive Diseases Center.

Courtesy Dr. Eric Esrailian

Dr. Esrailian, the son of Armenian immigrants, says that humanitarian work has been ingrained in him since childhood. His great-grandparents were Armenian genocide survivors and their struggles have never left him. He’s devoted his life not only to medicine, but to documenting the history of the Armenian genocide and leading, or supporting, efforts to resolve humanitarian crises in Armenia and around the world. Earlier this year, he, with Kim Kardashian and singer/actor Cher, published op-eds that addressed a humanitarian crisis building as a result of Azerbaijan’s blockade of the Lachin corridor – which is the only road that links Armenia to the ethnic Armenian–populated sections of Nagorno-Karabakh. In September, Armenia and Azerbaijan reached a tentative agreement to end the blockade, but more needs to be done, he says. Tragedies continue to unfold, and he is redoubling his efforts to bring more attention to this humanitarian crisis, he said.

Because storytelling is an important part of raising awareness, in 2016 Dr. Esrailian and partners produced two films about stories of perseverance, endurance, and the inextinguishable fire of the human spirit. The first film was “The Promise,” a historical war drama set in the Ottoman Empire and released in 2016. In 2017, he and partners released “Intent to Destroy: Death, Denial, & Depiction,” a documentary about the Armenian genocide. The documentary received an Emmy nomination for Outstanding Historical Documentary. And, in 2020, he produced “Francesco,” a film about Pope Francis that documented his pilgrimage to Armenia in 2016.

“The Promise” had such an impact on viewers that in 2017 Dr. Esrailian and the UCLA School of Law created The Promise Institute for Human Rights as a center of human rights education, research, and advocacy. In 2019, Dr. Esrailian and UCLA followed up with The Promise Armenian Institute as a place for academic research and teaching of Armenian studies, language, and culture. “The impact from building these two institutes has been transformational, and they will be part of UCLA forever,” he said.

His philanthropic efforts connecting health, human rights, education, and the arts has had an impact worldwide. One person can make a difference, Dr. Esrailian said: “I’ve learned along the way that an individual can have more of an impact than ever imagined, but you have to dream big and never give up.”

In this interview, he tells us more about his work.
 

Q: Not many doctors wear hats in medicine and filmmaking. Describe your journey as a filmmaker.

Dr. Esrailian: I’ve always been interested in storytelling. I was an English minor at Berkeley. My late mentor, Kirk Kerkorian, a legendary philanthropist, businessman, and entrepreneur, pushed me to take storytelling and do something that would potentially help secure Armenian Genocide recognition by the United States. Because of genocide denialists and geopolitical pressure, he felt the United States government was reluctant to recognize the Armenian Genocide. He thought having some visual materials for educational and outreach efforts would be transformational, and as it turns out, they were.

If you talk to any advocacy organization that tried for years to get Armenian Genocide recognition, they’d say that both films, “The Promise” (a feature film) and “Intent to Destroy” (a documentary), and the social impact media campaign we launched around them, were influential in moving the needle with legislators in the United States who, 3 years after “The Promise” was released, recognized the genocide. This was followed by the Library of Congress in 2020 and President Biden’s executive branch in 2021.
 

Q: What has been your most rewarding accomplishment?

Dr. Esrailian: Giving a voice to people who don’t have a voice is something that I’m proud of. Sometimes, it’s questionable what impact it may have because we still see atrocities committed all over the world. In September, Azerbaijan completed an ethnic cleansing campaign of Armenians from a region called Artsakh, officially the Republic of Nagorno-Karabakh.

Despite having so many relationships with powerful people in government and in high-profile media, and despite our documentaries, op-eds, and interactions with influential leaders on a regular basis, it always feels like it’s not enough. Obviously, the perpetrators are still able to abuse human rights and conduct these campaigns. Nevertheless, I don’t think we should be deterred. Allowing human rights violations to occur with impunity only emboldens perpetrators even more. It takes a long time to bring people to justice through international courts, but it does happen – eventually. That’s something I’m going to continue to work on.
 

Q: What should be the role of physicians in supporting human rights?

Dr. Esrailian: Physicians and health care providers play an important role in human rights. If you look back throughout history, whether it’s the International Committee of the Red Cross, or Doctors Without Borders, or other organizations, physicians and health care professionals are often on the front lines, helping people. Unfortunately, physicians have also been part of human rights violations, like the Holocaust or other genocides. But I do think that in this day and age, with the reputation that physicians have, we can be policy advocates and upstanders in addition to taking care of patients. Telling our stories to the world is important so that people know what’s actually happening on the ground.

Lightning round

Do you prefer texting or talking?  
Talking

How many cups of coffee do you drink each day?
Two

What was the last movie you watched?
Mission Impossible

If you weren’t a gastroenterologist, what would you be?  
Entrepreneur

Who inspires you?  
My family

When we launched GIHN’s monthly Member Spotlight column in January of this year, our vision was to provide a platform to recognize AGA members’ unique accomplishments across all career stages and practice settings, highlight the diversity of our membership, and build a sense of community by learning more about one another.

As physicians, we are fortunate to have the opportunity to meaningfully impact the lives of our patients through the practice of clinical medicine, or by spearheading groundbreaking research that improves patient outcomes. However, some physicians arguably make their greatest mark outside of medicine.

To close out the inaugural year of our Member Spotlight feature, we introduce you to gastroenterologist Eric Esrailian, MD, MPH, chair of the division of gastroenterology at UCLA. He is an Emmy-nominated film producer and distinguished human rights advocate. His story is inspirational, and poignantly highlights how one’s impact as a physician can extend far beyond the walls of the hospital. We hope to continue to feature exceptional individuals like Dr. Esrailian who leverage their unique talents for societal good. We appreciate your continued nominations as we plan our 2024 coverage.

Also in the December issue, we summarize the results of a pivotal, head-to-head trial of risankizumab (Skyrizi) and ustekinumab (Stelara) for Crohn’s disease, which was presented in October at United European Gastroenterology (UEG) Week in Copenhagen.

We also highlight the FDA’s recent approval of vonoprazan, a new pharmacologic treatment for erosive esophagitis expected to be available in the U.S. sometime this month. Finally, Dr. Lauren Feld explains how gastroenterologists can advocate for more robust parental leave and return to work policies at their institutions and why it matters.

We wish you all a wonderful holiday season and look forward to seeing you again in the New Year.

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

When we launched GIHN’s monthly Member Spotlight column in January of this year, our vision was to provide a platform to recognize AGA members’ unique accomplishments across all career stages and practice settings, highlight the diversity of our membership, and build a sense of community by learning more about one another.

As physicians, we are fortunate to have the opportunity to meaningfully impact the lives of our patients through the practice of clinical medicine, or by spearheading groundbreaking research that improves patient outcomes. However, some physicians arguably make their greatest mark outside of medicine.

To close out the inaugural year of our Member Spotlight feature, we introduce you to gastroenterologist Eric Esrailian, MD, MPH, chair of the division of gastroenterology at UCLA. He is an Emmy-nominated film producer and distinguished human rights advocate. His story is inspirational, and poignantly highlights how one’s impact as a physician can extend far beyond the walls of the hospital. We hope to continue to feature exceptional individuals like Dr. Esrailian who leverage their unique talents for societal good. We appreciate your continued nominations as we plan our 2024 coverage.

Also in the December issue, we summarize the results of a pivotal, head-to-head trial of risankizumab (Skyrizi) and ustekinumab (Stelara) for Crohn’s disease, which was presented in October at United European Gastroenterology (UEG) Week in Copenhagen.

We also highlight the FDA’s recent approval of vonoprazan, a new pharmacologic treatment for erosive esophagitis expected to be available in the U.S. sometime this month. Finally, Dr. Lauren Feld explains how gastroenterologists can advocate for more robust parental leave and return to work policies at their institutions and why it matters.

We wish you all a wonderful holiday season and look forward to seeing you again in the New Year.

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

When we launched GIHN’s monthly Member Spotlight column in January of this year, our vision was to provide a platform to recognize AGA members’ unique accomplishments across all career stages and practice settings, highlight the diversity of our membership, and build a sense of community by learning more about one another.

As physicians, we are fortunate to have the opportunity to meaningfully impact the lives of our patients through the practice of clinical medicine, or by spearheading groundbreaking research that improves patient outcomes. However, some physicians arguably make their greatest mark outside of medicine.

To close out the inaugural year of our Member Spotlight feature, we introduce you to gastroenterologist Eric Esrailian, MD, MPH, chair of the division of gastroenterology at UCLA. He is an Emmy-nominated film producer and distinguished human rights advocate. His story is inspirational, and poignantly highlights how one’s impact as a physician can extend far beyond the walls of the hospital. We hope to continue to feature exceptional individuals like Dr. Esrailian who leverage their unique talents for societal good. We appreciate your continued nominations as we plan our 2024 coverage.

Also in the December issue, we summarize the results of a pivotal, head-to-head trial of risankizumab (Skyrizi) and ustekinumab (Stelara) for Crohn’s disease, which was presented in October at United European Gastroenterology (UEG) Week in Copenhagen.

We also highlight the FDA’s recent approval of vonoprazan, a new pharmacologic treatment for erosive esophagitis expected to be available in the U.S. sometime this month. Finally, Dr. Lauren Feld explains how gastroenterologists can advocate for more robust parental leave and return to work policies at their institutions and why it matters.

We wish you all a wonderful holiday season and look forward to seeing you again in the New Year.

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

Use of fluticasone and budesonide for eosinophilic esophagitis during pregnancy had no significant adverse effect on maternal or fetal outcomes, according to new research presented at the annual meeting of the American College of Gastroenterology.

“Currently, there are no specific recommendations about the safe use of steroids in pregnant women with eosinophilic esophagitis (EoE), Julton Tomanguillo Chumbe, MD, said in an interview. “Our recommendations about the use of steroids among this population are based on the safety data extrapolated mainly from pregnant women with asthma.”

West Virginia University

In the study, Dr. Chumbe, an internal medicine resident at Charleston Area Medical Center, West Virginia University, Charleston, and colleagues identified pregnant patients aged 18 years and older with a diagnosis of EoE between January 2011 and December 2022 through the TriNetx Global Collaborative Network, which includes 101 health care organizations in 14 countries. The study population consisted of 1,263 individuals.

The researchers used propensity score matching (PSM) to compare the rates of spontaneous abortion, placenta previa, preeclampsia, premature delivery, HELLP syndrome, eclampsia, hyperemesis gravidarum, and major congenital abnormalities between women with EoE who did and did not use steroids during pregnancy. The PSM cohorts included 268 women in each group.

Overall, pregnant women who used steroids were not significantly more likely than were those who did not use steroids to experience spontaneous abortion (3.73% vs. 4.85%, P = .52). Rates of placenta previa, preeclampsia, premature delivery, HELLP syndrome, and hyperemesis gravidarum were equal between the groups (3.73% vs. 3.73%, P = 1.00 for all). No cases of eclampsia occurred in the steroid group, compared with a 3.73% rate in women who did not use steroids.

Incidence of major congenital abnormalities including but not limited to malformations of the eye, ear, face, neck, skull and face bones, and of the circulatory, respiratory, and digestive systems, were similar between the steroid and no steroid groups (7.09% vs. 8.20%, P = .62)

Dr. Chumbe said he was not surprised by the findings, given the robust data about the safe use of steroids in pregnant women with asthma, in terms of pregnancy outcomes and fetal outcomes.

“The findings of this study provide reassurance that the use of steroids in pregnant patients with eosinophilic esophagitis is not significantly associated with an increased risk of worse maternal or fetal outcomes,” he said. “During pregnancy, some patients may discontinue treatment due to safety concerns. However, this study suggests that this may not be necessary.” Consequently, patients can maintain EoE management while reducing the risk of complications.

Looking ahead, “it will be important to have some data about the safe use of dupilumab during pregnancy in patients with eosinophilic esophagitis,” he said.
 

Pregnant patients can maintain EoE management

“This study is able to address an important concern that many patients have regarding the safety of steroid therapy for EoE, particularly during pregnancy,” said Anita Afzali, MD, MPH, AGAF, a gastroenterologist specializing in inflammatory bowel disease and executive vice chair of internal medicine at the University of Cincinnati. “As EoE impacts over 40% of women, most who are in childbearing age, it is important to review the safety of treatment and management of EoE so a mother does not have to choose between EoE management and pregnancy.”

The results from this study were certainly reassuring, though not surprising, Dr. Afzali said. “Previously, the safety profile of steroids during pregnancy was mostly extrapolated from asthma, and other diseases such as inflammatory bowel disease. The results from this study confirm that there are no significant associations with adverse maternal or birth outcomes among women with EoE treated with steroids during pregnancy,” she said.

The study has some limitations, including the retrospective design and potential for selection bias, Dr. Afzali noted. “Further research is needed for the evaluation of newer therapies in the pipeline for treatment of EoE and its safety profile with pregnancy,” she said.

However, “sharing this information in clinical practice “will allow our patients to feel comfortable with continuation of appropriate steroid therapy for treatment and management of their EoE, without having to choose between family planning or pregnancy and EoE care management,” Dr. Afzali said.

The study received no outside funding. Dr. Chumbe an Dr. Afzali indicated having no relevant financial conflicts to disclose.

Use of fluticasone and budesonide for eosinophilic esophagitis during pregnancy had no significant adverse effect on maternal or fetal outcomes, according to new research presented at the annual meeting of the American College of Gastroenterology.

“Currently, there are no specific recommendations about the safe use of steroids in pregnant women with eosinophilic esophagitis (EoE), Julton Tomanguillo Chumbe, MD, said in an interview. “Our recommendations about the use of steroids among this population are based on the safety data extrapolated mainly from pregnant women with asthma.”

West Virginia University

In the study, Dr. Chumbe, an internal medicine resident at Charleston Area Medical Center, West Virginia University, Charleston, and colleagues identified pregnant patients aged 18 years and older with a diagnosis of EoE between January 2011 and December 2022 through the TriNetx Global Collaborative Network, which includes 101 health care organizations in 14 countries. The study population consisted of 1,263 individuals.

The researchers used propensity score matching (PSM) to compare the rates of spontaneous abortion, placenta previa, preeclampsia, premature delivery, HELLP syndrome, eclampsia, hyperemesis gravidarum, and major congenital abnormalities between women with EoE who did and did not use steroids during pregnancy. The PSM cohorts included 268 women in each group.

Overall, pregnant women who used steroids were not significantly more likely than were those who did not use steroids to experience spontaneous abortion (3.73% vs. 4.85%, P = .52). Rates of placenta previa, preeclampsia, premature delivery, HELLP syndrome, and hyperemesis gravidarum were equal between the groups (3.73% vs. 3.73%, P = 1.00 for all). No cases of eclampsia occurred in the steroid group, compared with a 3.73% rate in women who did not use steroids.

Incidence of major congenital abnormalities including but not limited to malformations of the eye, ear, face, neck, skull and face bones, and of the circulatory, respiratory, and digestive systems, were similar between the steroid and no steroid groups (7.09% vs. 8.20%, P = .62)

Dr. Chumbe said he was not surprised by the findings, given the robust data about the safe use of steroids in pregnant women with asthma, in terms of pregnancy outcomes and fetal outcomes.

“The findings of this study provide reassurance that the use of steroids in pregnant patients with eosinophilic esophagitis is not significantly associated with an increased risk of worse maternal or fetal outcomes,” he said. “During pregnancy, some patients may discontinue treatment due to safety concerns. However, this study suggests that this may not be necessary.” Consequently, patients can maintain EoE management while reducing the risk of complications.

Looking ahead, “it will be important to have some data about the safe use of dupilumab during pregnancy in patients with eosinophilic esophagitis,” he said.
 

Pregnant patients can maintain EoE management

“This study is able to address an important concern that many patients have regarding the safety of steroid therapy for EoE, particularly during pregnancy,” said Anita Afzali, MD, MPH, AGAF, a gastroenterologist specializing in inflammatory bowel disease and executive vice chair of internal medicine at the University of Cincinnati. “As EoE impacts over 40% of women, most who are in childbearing age, it is important to review the safety of treatment and management of EoE so a mother does not have to choose between EoE management and pregnancy.”

The results from this study were certainly reassuring, though not surprising, Dr. Afzali said. “Previously, the safety profile of steroids during pregnancy was mostly extrapolated from asthma, and other diseases such as inflammatory bowel disease. The results from this study confirm that there are no significant associations with adverse maternal or birth outcomes among women with EoE treated with steroids during pregnancy,” she said.

The study has some limitations, including the retrospective design and potential for selection bias, Dr. Afzali noted. “Further research is needed for the evaluation of newer therapies in the pipeline for treatment of EoE and its safety profile with pregnancy,” she said.

However, “sharing this information in clinical practice “will allow our patients to feel comfortable with continuation of appropriate steroid therapy for treatment and management of their EoE, without having to choose between family planning or pregnancy and EoE care management,” Dr. Afzali said.

The study received no outside funding. Dr. Chumbe an Dr. Afzali indicated having no relevant financial conflicts to disclose.

Use of fluticasone and budesonide for eosinophilic esophagitis during pregnancy had no significant adverse effect on maternal or fetal outcomes, according to new research presented at the annual meeting of the American College of Gastroenterology.

“Currently, there are no specific recommendations about the safe use of steroids in pregnant women with eosinophilic esophagitis (EoE), Julton Tomanguillo Chumbe, MD, said in an interview. “Our recommendations about the use of steroids among this population are based on the safety data extrapolated mainly from pregnant women with asthma.”

West Virginia University

In the study, Dr. Chumbe, an internal medicine resident at Charleston Area Medical Center, West Virginia University, Charleston, and colleagues identified pregnant patients aged 18 years and older with a diagnosis of EoE between January 2011 and December 2022 through the TriNetx Global Collaborative Network, which includes 101 health care organizations in 14 countries. The study population consisted of 1,263 individuals.

The researchers used propensity score matching (PSM) to compare the rates of spontaneous abortion, placenta previa, preeclampsia, premature delivery, HELLP syndrome, eclampsia, hyperemesis gravidarum, and major congenital abnormalities between women with EoE who did and did not use steroids during pregnancy. The PSM cohorts included 268 women in each group.

Overall, pregnant women who used steroids were not significantly more likely than were those who did not use steroids to experience spontaneous abortion (3.73% vs. 4.85%, P = .52). Rates of placenta previa, preeclampsia, premature delivery, HELLP syndrome, and hyperemesis gravidarum were equal between the groups (3.73% vs. 3.73%, P = 1.00 for all). No cases of eclampsia occurred in the steroid group, compared with a 3.73% rate in women who did not use steroids.

Incidence of major congenital abnormalities including but not limited to malformations of the eye, ear, face, neck, skull and face bones, and of the circulatory, respiratory, and digestive systems, were similar between the steroid and no steroid groups (7.09% vs. 8.20%, P = .62)

Dr. Chumbe said he was not surprised by the findings, given the robust data about the safe use of steroids in pregnant women with asthma, in terms of pregnancy outcomes and fetal outcomes.

“The findings of this study provide reassurance that the use of steroids in pregnant patients with eosinophilic esophagitis is not significantly associated with an increased risk of worse maternal or fetal outcomes,” he said. “During pregnancy, some patients may discontinue treatment due to safety concerns. However, this study suggests that this may not be necessary.” Consequently, patients can maintain EoE management while reducing the risk of complications.

Looking ahead, “it will be important to have some data about the safe use of dupilumab during pregnancy in patients with eosinophilic esophagitis,” he said.
 

Pregnant patients can maintain EoE management

“This study is able to address an important concern that many patients have regarding the safety of steroid therapy for EoE, particularly during pregnancy,” said Anita Afzali, MD, MPH, AGAF, a gastroenterologist specializing in inflammatory bowel disease and executive vice chair of internal medicine at the University of Cincinnati. “As EoE impacts over 40% of women, most who are in childbearing age, it is important to review the safety of treatment and management of EoE so a mother does not have to choose between EoE management and pregnancy.”

The results from this study were certainly reassuring, though not surprising, Dr. Afzali said. “Previously, the safety profile of steroids during pregnancy was mostly extrapolated from asthma, and other diseases such as inflammatory bowel disease. The results from this study confirm that there are no significant associations with adverse maternal or birth outcomes among women with EoE treated with steroids during pregnancy,” she said.

The study has some limitations, including the retrospective design and potential for selection bias, Dr. Afzali noted. “Further research is needed for the evaluation of newer therapies in the pipeline for treatment of EoE and its safety profile with pregnancy,” she said.

However, “sharing this information in clinical practice “will allow our patients to feel comfortable with continuation of appropriate steroid therapy for treatment and management of their EoE, without having to choose between family planning or pregnancy and EoE care management,” Dr. Afzali said.

The study received no outside funding. Dr. Chumbe an Dr. Afzali indicated having no relevant financial conflicts to disclose.

Physician burnout persists even as the height of the COVID-19 crisis fades farther into the rear-view mirror. The causes for the sadness, stress, and frustration among doctors vary, but the effects are universal and often debilitating: exhaustion, emotional detachment, lethargy, feeling useless, and lacking purpose. 

When surveyed, physicians pointed to many systemic solutions for burnout in Medscape’s Physician Burnout & Depression Report 2023, such as a need for greater compensation, more manageable workloads and schedules, and more support staff. But for many doctors, these fixes may be years if not decades away. Equally important are strategies for relieving burnout symptoms now, especially as we head into a busy holiday season.

Because not every stress-relief practice works for everyone, it’s crucial to try various methods until you find something that makes a difference for you, said Christine Gibson, MD, a family physician and trauma therapist in Calgary, Alta., and author of The Modern Trauma Toolkit.

“Every person should have a toolkit of the things that bring them out of the psychological and physical distress that dysregulates their nervous system,” said Dr. Gibson. 

Once you learn the personal ways to alleviate your specific brand of burnout, you can start working on systemic changes that might help the culture of medicine overall.

One or even more of these more unusual burnout prescriptions may be key to your personal emotional regulation and mental wellness.
 

Symptoms speak louder than words

It seems obvious, but if you aren’t aware that what you’re feeling is burnout, you probably aren’t going to find effective steps to relieve it. Jessi Gold, MD, assistant professor and director of wellness, engagement, and outreach in the department of psychiatry, Washington University in St. Louis, is a psychiatrist who treats health care professionals, including frontline workers during the height of the pandemic. But even as a burnout expert, she admits that she misses the signs in herself. 

“I was fighting constant fatigue, falling asleep the minute I got home from work every day, but I thought a B12 shot would solve all my problems. I didn’t realize I was having symptoms of burnout until my own therapist told me,” said Dr. Gold. “As doctors, we spend so much time focusing on other people that we don’t necessarily notice very much in ourselves – usually once it starts to impact our job.”

Practices like meditation and mindfulness can help you delve into your feelings and emotions and notice how you’re doing. But you may also need to ask spouses, partners, and friends and family – or better yet, a mental health professional – if they notice that you seem burnt out. 
 

Practice ‘in the moment’ relief 

Sometimes, walking away at the moment of stress helps like when stepping away from a heated argument. “Step out of a frustrating staff meeting to go to the bathroom and splash your face,” said Eran Magan, PhD, a psychologist at the University of Pennsylvania, Philadelphia, and founder and CEO of the suicide prevention system EarlyAlert.me. “Tell a patient you need to check something in the next room, so you have time to take a breath.” 

Dr. Magan recommended finding techniques that help lower acute stress while it’s actually happening. First, find a way to escape or excuse yourself from the event, and when possible, stop situations that are actively upsetting or triggering in their tracks. 

Next, recharge by doing something that helps you feel better, like looking at a cute video of your child or grandchild or closing your eyes and taking a deep breath. You can also try to “catch” good feelings from someone else, said Dr. Magan. Ask someone about a trip, vacation, holiday, or pleasant event. “Ask a colleague about something that makes [them] happy,” he said. “Happiness can be infectious too.”
 

Burnout is also in the body

“Body psychotherapy” or somatic therapy is a treatment that focuses on how emotions appear within your body. Dr. Gibson said it’s a valuable tool for addressing trauma and a mainstay in many a medical career; it’s useful to help physicians learn to “befriend” their nervous system. 

Somatic therapy exercises involve things like body scanning, scanning for physical sensations; conscious breathing, connecting to each inhale and exhale; grounding your weight by releasing tension through your feet, doing a total body stretch; or releasing shoulder and neck tension by consciously relaxing each of these muscle groups.

“We spend our whole day in sympathetic tone; our amygdala’s are firing, telling us that we’re in danger,” said Dr. Gibson. “We actually have to practice getting into and spending time in our parasympathetic nervous system to restore the balance in our autonomic nervous system.” 

Somatic therapy includes a wide array of exercises that help reconnect you to your body through calming or activation. The movements release tension, ground you, and restore balance. 
 

Bite-sized tools for well-being

Because of the prevalence of physician burnout, there’s been a groundswell of researchers and organizations who have turned their focus toward improving the well-being in the health care workforce. 

One such effort comes from the Duke Center for the Advancement of Well-being Science, which “camouflages” well-being tools as continuing education credits to make them accessible for busy, stressed, and overworked physicians.

“They’re called bite-sized tools for well-being, and they have actual evidence behind them,” said Dr. Gold. For example, she said, one tools is a text program called Three Good Things that encourages physicians to send a text listing three positive things that happened during the day. The exercise lasts 15 days, and texters have access to others’ answers as well. After 3 months, participants’ baseline depression, gratitude, and life satisfaction had all “significantly improved.”

“It feels almost ridiculous that that could work, but it does,” said Dr. Gold. “I’ve had patients push back and say: ‘Well, isn’t that toxic positivity?’ But really what it is is dialectics. It’s not saying there’s only positive; it’s just making you realize there is more than just the negative.”

These and other short interventions focus on concepts such as joy, humor, awe, engagement, and self-kindness to build resilience and help physicians recover from burnout symptoms. 
 

Cognitive restructuring could work

Cognitive restructuring is a therapeutic process of learning new ways of interpreting and responding to people and situations. It helps you change the “filter” through which you interact with your environment. Dr. Gibson said it’s a tool to use with care after other modes of therapy that help you understand your patterns and how they developed because of how you view and understand the world. 

“The message of [cognitive-behavioral therapy] or cognitive restructuring is there’s something wrong with the way you’re thinking, and we need to change it or fix it, but in a traumatic system [like health care], you’re thinking has been an adaptive process related to the harm in the environment you’re in,” said Dr. Gibson. 

“So, if you [jump straight to cognitive restructuring before other types of therapy], then we just gaslight ourselves into believing that there’s something wrong with us, that we haven’t adapted sufficiently to an environment that’s actually harmful.”
 

Strive for a few systemic changes

Systemic changes can be small ones within your own sphere. For example, Dr. Magan said, work toward making little tweaks to the flow of your day that will increase calm and reduce frustration. 

“Make a ‘bug list,’ little, regular demands that drain your energy, and discuss them with your colleagues and supervisors to see if they can be improved,” he said. Examples include everyday frustrations like having unsolicited visitors popping into your office, scheduling complex patients too late in the day, or having a computer freeze whenever you access patient charts.

Though not always financially feasible, affecting real change and finding relief from all these insidious bugs can improve your mental health and burnout symptoms.

“Physicians tend to work extremely hard in order to keep holding together a system that is often not inherently sustainable, like the fascia of a body under tremendous strain,” said Dr. Magan. “Sometimes the brave thing to do is to refuse to continue being the lynchpin and let things break, so the system will have to start improving itself, rather than demanding more and more of the people in it.”

A version of this article first appeared on Medscape.com.

Physician burnout persists even as the height of the COVID-19 crisis fades farther into the rear-view mirror. The causes for the sadness, stress, and frustration among doctors vary, but the effects are universal and often debilitating: exhaustion, emotional detachment, lethargy, feeling useless, and lacking purpose. 

When surveyed, physicians pointed to many systemic solutions for burnout in Medscape’s Physician Burnout & Depression Report 2023, such as a need for greater compensation, more manageable workloads and schedules, and more support staff. But for many doctors, these fixes may be years if not decades away. Equally important are strategies for relieving burnout symptoms now, especially as we head into a busy holiday season.

Because not every stress-relief practice works for everyone, it’s crucial to try various methods until you find something that makes a difference for you, said Christine Gibson, MD, a family physician and trauma therapist in Calgary, Alta., and author of The Modern Trauma Toolkit.

“Every person should have a toolkit of the things that bring them out of the psychological and physical distress that dysregulates their nervous system,” said Dr. Gibson. 

Once you learn the personal ways to alleviate your specific brand of burnout, you can start working on systemic changes that might help the culture of medicine overall.

One or even more of these more unusual burnout prescriptions may be key to your personal emotional regulation and mental wellness.
 

Symptoms speak louder than words

It seems obvious, but if you aren’t aware that what you’re feeling is burnout, you probably aren’t going to find effective steps to relieve it. Jessi Gold, MD, assistant professor and director of wellness, engagement, and outreach in the department of psychiatry, Washington University in St. Louis, is a psychiatrist who treats health care professionals, including frontline workers during the height of the pandemic. But even as a burnout expert, she admits that she misses the signs in herself. 

“I was fighting constant fatigue, falling asleep the minute I got home from work every day, but I thought a B12 shot would solve all my problems. I didn’t realize I was having symptoms of burnout until my own therapist told me,” said Dr. Gold. “As doctors, we spend so much time focusing on other people that we don’t necessarily notice very much in ourselves – usually once it starts to impact our job.”

Practices like meditation and mindfulness can help you delve into your feelings and emotions and notice how you’re doing. But you may also need to ask spouses, partners, and friends and family – or better yet, a mental health professional – if they notice that you seem burnt out. 
 

Practice ‘in the moment’ relief 

Sometimes, walking away at the moment of stress helps like when stepping away from a heated argument. “Step out of a frustrating staff meeting to go to the bathroom and splash your face,” said Eran Magan, PhD, a psychologist at the University of Pennsylvania, Philadelphia, and founder and CEO of the suicide prevention system EarlyAlert.me. “Tell a patient you need to check something in the next room, so you have time to take a breath.” 

Dr. Magan recommended finding techniques that help lower acute stress while it’s actually happening. First, find a way to escape or excuse yourself from the event, and when possible, stop situations that are actively upsetting or triggering in their tracks. 

Next, recharge by doing something that helps you feel better, like looking at a cute video of your child or grandchild or closing your eyes and taking a deep breath. You can also try to “catch” good feelings from someone else, said Dr. Magan. Ask someone about a trip, vacation, holiday, or pleasant event. “Ask a colleague about something that makes [them] happy,” he said. “Happiness can be infectious too.”
 

Burnout is also in the body

“Body psychotherapy” or somatic therapy is a treatment that focuses on how emotions appear within your body. Dr. Gibson said it’s a valuable tool for addressing trauma and a mainstay in many a medical career; it’s useful to help physicians learn to “befriend” their nervous system. 

Somatic therapy exercises involve things like body scanning, scanning for physical sensations; conscious breathing, connecting to each inhale and exhale; grounding your weight by releasing tension through your feet, doing a total body stretch; or releasing shoulder and neck tension by consciously relaxing each of these muscle groups.

“We spend our whole day in sympathetic tone; our amygdala’s are firing, telling us that we’re in danger,” said Dr. Gibson. “We actually have to practice getting into and spending time in our parasympathetic nervous system to restore the balance in our autonomic nervous system.” 

Somatic therapy includes a wide array of exercises that help reconnect you to your body through calming or activation. The movements release tension, ground you, and restore balance. 
 

Bite-sized tools for well-being

Because of the prevalence of physician burnout, there’s been a groundswell of researchers and organizations who have turned their focus toward improving the well-being in the health care workforce. 

One such effort comes from the Duke Center for the Advancement of Well-being Science, which “camouflages” well-being tools as continuing education credits to make them accessible for busy, stressed, and overworked physicians.

“They’re called bite-sized tools for well-being, and they have actual evidence behind them,” said Dr. Gold. For example, she said, one tools is a text program called Three Good Things that encourages physicians to send a text listing three positive things that happened during the day. The exercise lasts 15 days, and texters have access to others’ answers as well. After 3 months, participants’ baseline depression, gratitude, and life satisfaction had all “significantly improved.”

“It feels almost ridiculous that that could work, but it does,” said Dr. Gold. “I’ve had patients push back and say: ‘Well, isn’t that toxic positivity?’ But really what it is is dialectics. It’s not saying there’s only positive; it’s just making you realize there is more than just the negative.”

These and other short interventions focus on concepts such as joy, humor, awe, engagement, and self-kindness to build resilience and help physicians recover from burnout symptoms. 
 

Cognitive restructuring could work

Cognitive restructuring is a therapeutic process of learning new ways of interpreting and responding to people and situations. It helps you change the “filter” through which you interact with your environment. Dr. Gibson said it’s a tool to use with care after other modes of therapy that help you understand your patterns and how they developed because of how you view and understand the world. 

“The message of [cognitive-behavioral therapy] or cognitive restructuring is there’s something wrong with the way you’re thinking, and we need to change it or fix it, but in a traumatic system [like health care], you’re thinking has been an adaptive process related to the harm in the environment you’re in,” said Dr. Gibson. 

“So, if you [jump straight to cognitive restructuring before other types of therapy], then we just gaslight ourselves into believing that there’s something wrong with us, that we haven’t adapted sufficiently to an environment that’s actually harmful.”
 

Strive for a few systemic changes

Systemic changes can be small ones within your own sphere. For example, Dr. Magan said, work toward making little tweaks to the flow of your day that will increase calm and reduce frustration. 

“Make a ‘bug list,’ little, regular demands that drain your energy, and discuss them with your colleagues and supervisors to see if they can be improved,” he said. Examples include everyday frustrations like having unsolicited visitors popping into your office, scheduling complex patients too late in the day, or having a computer freeze whenever you access patient charts.

Though not always financially feasible, affecting real change and finding relief from all these insidious bugs can improve your mental health and burnout symptoms.

“Physicians tend to work extremely hard in order to keep holding together a system that is often not inherently sustainable, like the fascia of a body under tremendous strain,” said Dr. Magan. “Sometimes the brave thing to do is to refuse to continue being the lynchpin and let things break, so the system will have to start improving itself, rather than demanding more and more of the people in it.”

A version of this article first appeared on Medscape.com.

Physician burnout persists even as the height of the COVID-19 crisis fades farther into the rear-view mirror. The causes for the sadness, stress, and frustration among doctors vary, but the effects are universal and often debilitating: exhaustion, emotional detachment, lethargy, feeling useless, and lacking purpose. 

When surveyed, physicians pointed to many systemic solutions for burnout in Medscape’s Physician Burnout & Depression Report 2023, such as a need for greater compensation, more manageable workloads and schedules, and more support staff. But for many doctors, these fixes may be years if not decades away. Equally important are strategies for relieving burnout symptoms now, especially as we head into a busy holiday season.

Because not every stress-relief practice works for everyone, it’s crucial to try various methods until you find something that makes a difference for you, said Christine Gibson, MD, a family physician and trauma therapist in Calgary, Alta., and author of The Modern Trauma Toolkit.

“Every person should have a toolkit of the things that bring them out of the psychological and physical distress that dysregulates their nervous system,” said Dr. Gibson. 

Once you learn the personal ways to alleviate your specific brand of burnout, you can start working on systemic changes that might help the culture of medicine overall.

One or even more of these more unusual burnout prescriptions may be key to your personal emotional regulation and mental wellness.
 

Symptoms speak louder than words

It seems obvious, but if you aren’t aware that what you’re feeling is burnout, you probably aren’t going to find effective steps to relieve it. Jessi Gold, MD, assistant professor and director of wellness, engagement, and outreach in the department of psychiatry, Washington University in St. Louis, is a psychiatrist who treats health care professionals, including frontline workers during the height of the pandemic. But even as a burnout expert, she admits that she misses the signs in herself. 

“I was fighting constant fatigue, falling asleep the minute I got home from work every day, but I thought a B12 shot would solve all my problems. I didn’t realize I was having symptoms of burnout until my own therapist told me,” said Dr. Gold. “As doctors, we spend so much time focusing on other people that we don’t necessarily notice very much in ourselves – usually once it starts to impact our job.”

Practices like meditation and mindfulness can help you delve into your feelings and emotions and notice how you’re doing. But you may also need to ask spouses, partners, and friends and family – or better yet, a mental health professional – if they notice that you seem burnt out. 
 

Practice ‘in the moment’ relief 

Sometimes, walking away at the moment of stress helps like when stepping away from a heated argument. “Step out of a frustrating staff meeting to go to the bathroom and splash your face,” said Eran Magan, PhD, a psychologist at the University of Pennsylvania, Philadelphia, and founder and CEO of the suicide prevention system EarlyAlert.me. “Tell a patient you need to check something in the next room, so you have time to take a breath.” 

Dr. Magan recommended finding techniques that help lower acute stress while it’s actually happening. First, find a way to escape or excuse yourself from the event, and when possible, stop situations that are actively upsetting or triggering in their tracks. 

Next, recharge by doing something that helps you feel better, like looking at a cute video of your child or grandchild or closing your eyes and taking a deep breath. You can also try to “catch” good feelings from someone else, said Dr. Magan. Ask someone about a trip, vacation, holiday, or pleasant event. “Ask a colleague about something that makes [them] happy,” he said. “Happiness can be infectious too.”
 

Burnout is also in the body

“Body psychotherapy” or somatic therapy is a treatment that focuses on how emotions appear within your body. Dr. Gibson said it’s a valuable tool for addressing trauma and a mainstay in many a medical career; it’s useful to help physicians learn to “befriend” their nervous system. 

Somatic therapy exercises involve things like body scanning, scanning for physical sensations; conscious breathing, connecting to each inhale and exhale; grounding your weight by releasing tension through your feet, doing a total body stretch; or releasing shoulder and neck tension by consciously relaxing each of these muscle groups.

“We spend our whole day in sympathetic tone; our amygdala’s are firing, telling us that we’re in danger,” said Dr. Gibson. “We actually have to practice getting into and spending time in our parasympathetic nervous system to restore the balance in our autonomic nervous system.” 

Somatic therapy includes a wide array of exercises that help reconnect you to your body through calming or activation. The movements release tension, ground you, and restore balance. 
 

Bite-sized tools for well-being

Because of the prevalence of physician burnout, there’s been a groundswell of researchers and organizations who have turned their focus toward improving the well-being in the health care workforce. 

One such effort comes from the Duke Center for the Advancement of Well-being Science, which “camouflages” well-being tools as continuing education credits to make them accessible for busy, stressed, and overworked physicians.

“They’re called bite-sized tools for well-being, and they have actual evidence behind them,” said Dr. Gold. For example, she said, one tools is a text program called Three Good Things that encourages physicians to send a text listing three positive things that happened during the day. The exercise lasts 15 days, and texters have access to others’ answers as well. After 3 months, participants’ baseline depression, gratitude, and life satisfaction had all “significantly improved.”

“It feels almost ridiculous that that could work, but it does,” said Dr. Gold. “I’ve had patients push back and say: ‘Well, isn’t that toxic positivity?’ But really what it is is dialectics. It’s not saying there’s only positive; it’s just making you realize there is more than just the negative.”

These and other short interventions focus on concepts such as joy, humor, awe, engagement, and self-kindness to build resilience and help physicians recover from burnout symptoms. 
 

Cognitive restructuring could work

Cognitive restructuring is a therapeutic process of learning new ways of interpreting and responding to people and situations. It helps you change the “filter” through which you interact with your environment. Dr. Gibson said it’s a tool to use with care after other modes of therapy that help you understand your patterns and how they developed because of how you view and understand the world. 

“The message of [cognitive-behavioral therapy] or cognitive restructuring is there’s something wrong with the way you’re thinking, and we need to change it or fix it, but in a traumatic system [like health care], you’re thinking has been an adaptive process related to the harm in the environment you’re in,” said Dr. Gibson. 

“So, if you [jump straight to cognitive restructuring before other types of therapy], then we just gaslight ourselves into believing that there’s something wrong with us, that we haven’t adapted sufficiently to an environment that’s actually harmful.”
 

Strive for a few systemic changes

Systemic changes can be small ones within your own sphere. For example, Dr. Magan said, work toward making little tweaks to the flow of your day that will increase calm and reduce frustration. 

“Make a ‘bug list,’ little, regular demands that drain your energy, and discuss them with your colleagues and supervisors to see if they can be improved,” he said. Examples include everyday frustrations like having unsolicited visitors popping into your office, scheduling complex patients too late in the day, or having a computer freeze whenever you access patient charts.

Though not always financially feasible, affecting real change and finding relief from all these insidious bugs can improve your mental health and burnout symptoms.

“Physicians tend to work extremely hard in order to keep holding together a system that is often not inherently sustainable, like the fascia of a body under tremendous strain,” said Dr. Magan. “Sometimes the brave thing to do is to refuse to continue being the lynchpin and let things break, so the system will have to start improving itself, rather than demanding more and more of the people in it.”

A version of this article first appeared on Medscape.com.

Isotretinoin users have no increased risk of suicide or psychiatric conditions on a population level, a meta-analysis of 25 studies that included 1.6 million patients suggests.

Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.

The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I² [measuring heterogeneity] = 77%) in 11 studies.
 

Less likely to attempt suicide

Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I² = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I² = 23%) following treatment.

Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I² = 0%).

Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
 

“Two things can be true”

John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.

Dr. Barbieri

The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.

In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”

He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.

“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”

Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.

In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
 

What a meta-analysis might miss

In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.

They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”

Far from the “final word”

Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”

Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.

Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.

Isotretinoin users have no increased risk of suicide or psychiatric conditions on a population level, a meta-analysis of 25 studies that included 1.6 million patients suggests.

Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.

The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I² [measuring heterogeneity] = 77%) in 11 studies.
 

Less likely to attempt suicide

Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I² = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I² = 23%) following treatment.

Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I² = 0%).

Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
 

“Two things can be true”

John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.

Dr. Barbieri

The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.

In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”

He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.

“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”

Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.

In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
 

What a meta-analysis might miss

In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.

They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”

Far from the “final word”

Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”

Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.

Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.

Isotretinoin users have no increased risk of suicide or psychiatric conditions on a population level, a meta-analysis of 25 studies that included 1.6 million patients suggests.

Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.

The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I² [measuring heterogeneity] = 77%) in 11 studies.
 

Less likely to attempt suicide

Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I² = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I² = 23%) following treatment.

Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I² = 0%).

Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
 

“Two things can be true”

John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.

Dr. Barbieri

The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.

In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”

He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.

“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”

Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.

In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
 

What a meta-analysis might miss

In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.

They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”

Far from the “final word”

Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”

Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.

Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.

The antiseizure drugs levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam, generic) and clobazam (Onfi, Sympazan, generic) can cause a rare but serious drug hypersensitivity reaction that can be life threatening if not detected and treated promptly, the Food and Drug Administration warns in an alert.

Known as drug reaction with eosinophilia and systemic symptoms (DRESS), it may start as a rash but can quickly progress and cause injury to internal organs, the need for hospitalization, and death, the FDA notes.

A search of the FDA Adverse Event Reporting System (FAERS) and the medical literature through March 2023 identified 32 serious cases of DRESS worldwide that were associated with levetiracetam.

Three cases occurred in the United States, and 29 occurred abroad. In all 32 cases, the patients were hospitalized and received medical treatment; in 2 cases, the patients died.

The median time to onset of DRESS in the levetiracetam cases was 24 days; times ranged from 7 to 170 days. The reported signs and symptoms included skin rash (n = 22), fever (n = 20), eosinophilia (n = 17), lymph node swelling (n = 9), and atypical lymphocytes (n = 4).

Twenty-two levetiracetam-associated cases of DRESS involved injury to one or more organs, including the liver, lungs, kidneys, and gallbladder.

In 25 of the 29 cases for which information on treatment discontinuation was available, DRESS symptoms resolved when levetiracetam was discontinued.

As for clobazam, a search of FAERS and the medical literature through July 2023 identified 10 serious cases of DRESS worldwide – 1 in the United States and 9 abroad. All 10 patients were hospitalized and received medical treatment. No deaths were reported.

The median time to onset of clobazam-associated DRESS was 21.5 days (range, 7-103 days). The reported signs and symptoms included skin rash (n = 10), fever (n = 8), eosinophilia (n = 7), facial swelling (n = 7), leukocytosis (n = 4), lymph node swelling (n = 4), and leukopenia/thrombocytopenia (n = 1).

In nine cases, there was injury to one or more organs, including the liver, kidneys, and gastrointestinal tract.

DRESS symptoms resolved in all 10 cases when treatment with clobazam was stopped. DRESS and other serious skin reactions reported with clobazam, a benzodiazepine, have not generally been associated with other benzodiazepines, the FDA notes.

Label updates

As a result of these cases, warnings about the risk of DRESS will be added to the prescribing information and patient medication guides for these medicines, the FDA announced.

“Health care professionals should be aware that prompt recognition and early treatment is important for improving DRESS outcomes and decreasing mortality,” the FDA said.

They noted that diagnosis is often difficult because early signs and symptoms, such as fever and swollen lymph nodes, may be present without evidence of a rash.

DRESS may develop 2-8 weeks after starting levetiracetam or clobazam. Symptoms and intensity can vary widely.

DRESS can also be confused with other serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

The FDA says patients should be advised of the signs and symptoms of DRESS and be told to stop taking the medicine and seek immediate medical attention if DRESS is suspected during treatment with levetiracetam or clobazam.

Adverse reactions with these medications should be reported to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

The antiseizure drugs levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam, generic) and clobazam (Onfi, Sympazan, generic) can cause a rare but serious drug hypersensitivity reaction that can be life threatening if not detected and treated promptly, the Food and Drug Administration warns in an alert.

Known as drug reaction with eosinophilia and systemic symptoms (DRESS), it may start as a rash but can quickly progress and cause injury to internal organs, the need for hospitalization, and death, the FDA notes.

A search of the FDA Adverse Event Reporting System (FAERS) and the medical literature through March 2023 identified 32 serious cases of DRESS worldwide that were associated with levetiracetam.

Three cases occurred in the United States, and 29 occurred abroad. In all 32 cases, the patients were hospitalized and received medical treatment; in 2 cases, the patients died.

The median time to onset of DRESS in the levetiracetam cases was 24 days; times ranged from 7 to 170 days. The reported signs and symptoms included skin rash (n = 22), fever (n = 20), eosinophilia (n = 17), lymph node swelling (n = 9), and atypical lymphocytes (n = 4).

Twenty-two levetiracetam-associated cases of DRESS involved injury to one or more organs, including the liver, lungs, kidneys, and gallbladder.

In 25 of the 29 cases for which information on treatment discontinuation was available, DRESS symptoms resolved when levetiracetam was discontinued.

As for clobazam, a search of FAERS and the medical literature through July 2023 identified 10 serious cases of DRESS worldwide – 1 in the United States and 9 abroad. All 10 patients were hospitalized and received medical treatment. No deaths were reported.

The median time to onset of clobazam-associated DRESS was 21.5 days (range, 7-103 days). The reported signs and symptoms included skin rash (n = 10), fever (n = 8), eosinophilia (n = 7), facial swelling (n = 7), leukocytosis (n = 4), lymph node swelling (n = 4), and leukopenia/thrombocytopenia (n = 1).

In nine cases, there was injury to one or more organs, including the liver, kidneys, and gastrointestinal tract.

DRESS symptoms resolved in all 10 cases when treatment with clobazam was stopped. DRESS and other serious skin reactions reported with clobazam, a benzodiazepine, have not generally been associated with other benzodiazepines, the FDA notes.

Label updates

As a result of these cases, warnings about the risk of DRESS will be added to the prescribing information and patient medication guides for these medicines, the FDA announced.

“Health care professionals should be aware that prompt recognition and early treatment is important for improving DRESS outcomes and decreasing mortality,” the FDA said.

They noted that diagnosis is often difficult because early signs and symptoms, such as fever and swollen lymph nodes, may be present without evidence of a rash.

DRESS may develop 2-8 weeks after starting levetiracetam or clobazam. Symptoms and intensity can vary widely.

DRESS can also be confused with other serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

The FDA says patients should be advised of the signs and symptoms of DRESS and be told to stop taking the medicine and seek immediate medical attention if DRESS is suspected during treatment with levetiracetam or clobazam.

Adverse reactions with these medications should be reported to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

The antiseizure drugs levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam, generic) and clobazam (Onfi, Sympazan, generic) can cause a rare but serious drug hypersensitivity reaction that can be life threatening if not detected and treated promptly, the Food and Drug Administration warns in an alert.

Known as drug reaction with eosinophilia and systemic symptoms (DRESS), it may start as a rash but can quickly progress and cause injury to internal organs, the need for hospitalization, and death, the FDA notes.

A search of the FDA Adverse Event Reporting System (FAERS) and the medical literature through March 2023 identified 32 serious cases of DRESS worldwide that were associated with levetiracetam.

Three cases occurred in the United States, and 29 occurred abroad. In all 32 cases, the patients were hospitalized and received medical treatment; in 2 cases, the patients died.

The median time to onset of DRESS in the levetiracetam cases was 24 days; times ranged from 7 to 170 days. The reported signs and symptoms included skin rash (n = 22), fever (n = 20), eosinophilia (n = 17), lymph node swelling (n = 9), and atypical lymphocytes (n = 4).

Twenty-two levetiracetam-associated cases of DRESS involved injury to one or more organs, including the liver, lungs, kidneys, and gallbladder.

In 25 of the 29 cases for which information on treatment discontinuation was available, DRESS symptoms resolved when levetiracetam was discontinued.

As for clobazam, a search of FAERS and the medical literature through July 2023 identified 10 serious cases of DRESS worldwide – 1 in the United States and 9 abroad. All 10 patients were hospitalized and received medical treatment. No deaths were reported.

The median time to onset of clobazam-associated DRESS was 21.5 days (range, 7-103 days). The reported signs and symptoms included skin rash (n = 10), fever (n = 8), eosinophilia (n = 7), facial swelling (n = 7), leukocytosis (n = 4), lymph node swelling (n = 4), and leukopenia/thrombocytopenia (n = 1).

In nine cases, there was injury to one or more organs, including the liver, kidneys, and gastrointestinal tract.

DRESS symptoms resolved in all 10 cases when treatment with clobazam was stopped. DRESS and other serious skin reactions reported with clobazam, a benzodiazepine, have not generally been associated with other benzodiazepines, the FDA notes.

Label updates

As a result of these cases, warnings about the risk of DRESS will be added to the prescribing information and patient medication guides for these medicines, the FDA announced.

“Health care professionals should be aware that prompt recognition and early treatment is important for improving DRESS outcomes and decreasing mortality,” the FDA said.

They noted that diagnosis is often difficult because early signs and symptoms, such as fever and swollen lymph nodes, may be present without evidence of a rash.

DRESS may develop 2-8 weeks after starting levetiracetam or clobazam. Symptoms and intensity can vary widely.

DRESS can also be confused with other serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

The FDA says patients should be advised of the signs and symptoms of DRESS and be told to stop taking the medicine and seek immediate medical attention if DRESS is suspected during treatment with levetiracetam or clobazam.

Adverse reactions with these medications should be reported to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

TOPLINE:

An international expert consensus offers guidance to diagnose, assess, and treat adult patients experiencing drug reaction with eosinophilia and systemic symptoms (DRESS).

METHODOLOGY:

Data on the evaluation, assessment, and treatment of the rare but potentially life-threatening drug hypersensitivity reaction are lacking.

To support clinicians in diagnosing and managing DRESS, a steering committee conducted a literature review to examine current research, identify evidence, and develop consensus statements. They invited experts from 21 countries across four continents to participate in a Delphi consensus process.

An international panel of 54 experts (including 45 dermatologists) initially assessed 100 statements related to baseline workup, severity of the condition, and treatment. Two more statements were added in the second round.

After revisions and the second round, the group reached consensus for 93 statements overall.

TAKEAWAY:

The statements generating the most disagreement involved diagnosis. The group ultimately supported the value of measuring the viral load of Epstein-Barr virus, cytomegalovirus, and human herpesvirus 6 in all patients with suspected DRESS. The group also agreed on screening for hepatitis A, B, and C in cases of liver involvement and screening for hepatitis B and C before starting systemic therapy.

The group agreed with previous severity criteria that differentiate between mild, moderate, and severe DRESS based on the extent of liver, kidney, and blood involvement and the damage of other organs.

Consensus on treatment was reached for all 12 relevant statements in the first Delphi round. Recommendations included the use of corticosteroids and immediate discontinuation of the drugs causing the reaction.

IN PRACTICE:

“This Delphi exercise aimed to provide a common ground of consensus,” the authors noted. However, “each of the addressed categories needs more in-depth follow-up studies to improve the clinical management of patients.”

SOURCE:

The DRESS Delphi consensus group conducted its exercise under the leadership of Marie-Charlotte Brüggen, MD, of the University Hospital of Zürich. The consensus was published online in the JAMA Dermatology.

LIMITATIONS:

Published evidence was limited because of the low prevalence of DRESS. The consensus statements should therefore be considered with caution and in the context of a clinician’s expertise and available resources. Research gaps also persist in how DRESS may vary with region and ethnicity. The severity thresholds need validation in a revised multicenter statement.

DISCLOSURES:

The consensus review received no outside funding. Dr. Brüggen disclosed relationships with the Swiss National Science Foundation, Christine Kühne – Center for Allergy Research and Education, FreeNovation, LEO Foundation, Olga Mayenfisch Foundation, University of Zürich, LEO Pharma, Pierre Fabre Eczema Foundation, Eli Lilly, AbbVie, GSK, and AstraZeneca. Coauthors disclosed relationships with multiple pharmaceutical companies, foundations, and medical publishing companies.

A version of this article appeared on Medscape.com.

TOPLINE:

An international expert consensus offers guidance to diagnose, assess, and treat adult patients experiencing drug reaction with eosinophilia and systemic symptoms (DRESS).

METHODOLOGY:

Data on the evaluation, assessment, and treatment of the rare but potentially life-threatening drug hypersensitivity reaction are lacking.

To support clinicians in diagnosing and managing DRESS, a steering committee conducted a literature review to examine current research, identify evidence, and develop consensus statements. They invited experts from 21 countries across four continents to participate in a Delphi consensus process.

An international panel of 54 experts (including 45 dermatologists) initially assessed 100 statements related to baseline workup, severity of the condition, and treatment. Two more statements were added in the second round.

After revisions and the second round, the group reached consensus for 93 statements overall.

TAKEAWAY:

The statements generating the most disagreement involved diagnosis. The group ultimately supported the value of measuring the viral load of Epstein-Barr virus, cytomegalovirus, and human herpesvirus 6 in all patients with suspected DRESS. The group also agreed on screening for hepatitis A, B, and C in cases of liver involvement and screening for hepatitis B and C before starting systemic therapy.

The group agreed with previous severity criteria that differentiate between mild, moderate, and severe DRESS based on the extent of liver, kidney, and blood involvement and the damage of other organs.

Consensus on treatment was reached for all 12 relevant statements in the first Delphi round. Recommendations included the use of corticosteroids and immediate discontinuation of the drugs causing the reaction.

IN PRACTICE:

“This Delphi exercise aimed to provide a common ground of consensus,” the authors noted. However, “each of the addressed categories needs more in-depth follow-up studies to improve the clinical management of patients.”

SOURCE:

The DRESS Delphi consensus group conducted its exercise under the leadership of Marie-Charlotte Brüggen, MD, of the University Hospital of Zürich. The consensus was published online in the JAMA Dermatology.

LIMITATIONS:

Published evidence was limited because of the low prevalence of DRESS. The consensus statements should therefore be considered with caution and in the context of a clinician’s expertise and available resources. Research gaps also persist in how DRESS may vary with region and ethnicity. The severity thresholds need validation in a revised multicenter statement.

DISCLOSURES:

The consensus review received no outside funding. Dr. Brüggen disclosed relationships with the Swiss National Science Foundation, Christine Kühne – Center for Allergy Research and Education, FreeNovation, LEO Foundation, Olga Mayenfisch Foundation, University of Zürich, LEO Pharma, Pierre Fabre Eczema Foundation, Eli Lilly, AbbVie, GSK, and AstraZeneca. Coauthors disclosed relationships with multiple pharmaceutical companies, foundations, and medical publishing companies.

A version of this article appeared on Medscape.com.

TOPLINE:

An international expert consensus offers guidance to diagnose, assess, and treat adult patients experiencing drug reaction with eosinophilia and systemic symptoms (DRESS).

METHODOLOGY:

Data on the evaluation, assessment, and treatment of the rare but potentially life-threatening drug hypersensitivity reaction are lacking.

To support clinicians in diagnosing and managing DRESS, a steering committee conducted a literature review to examine current research, identify evidence, and develop consensus statements. They invited experts from 21 countries across four continents to participate in a Delphi consensus process.

An international panel of 54 experts (including 45 dermatologists) initially assessed 100 statements related to baseline workup, severity of the condition, and treatment. Two more statements were added in the second round.

After revisions and the second round, the group reached consensus for 93 statements overall.

TAKEAWAY:

The statements generating the most disagreement involved diagnosis. The group ultimately supported the value of measuring the viral load of Epstein-Barr virus, cytomegalovirus, and human herpesvirus 6 in all patients with suspected DRESS. The group also agreed on screening for hepatitis A, B, and C in cases of liver involvement and screening for hepatitis B and C before starting systemic therapy.

The group agreed with previous severity criteria that differentiate between mild, moderate, and severe DRESS based on the extent of liver, kidney, and blood involvement and the damage of other organs.

Consensus on treatment was reached for all 12 relevant statements in the first Delphi round. Recommendations included the use of corticosteroids and immediate discontinuation of the drugs causing the reaction.

IN PRACTICE:

“This Delphi exercise aimed to provide a common ground of consensus,” the authors noted. However, “each of the addressed categories needs more in-depth follow-up studies to improve the clinical management of patients.”

SOURCE:

The DRESS Delphi consensus group conducted its exercise under the leadership of Marie-Charlotte Brüggen, MD, of the University Hospital of Zürich. The consensus was published online in the JAMA Dermatology.

LIMITATIONS:

Published evidence was limited because of the low prevalence of DRESS. The consensus statements should therefore be considered with caution and in the context of a clinician’s expertise and available resources. Research gaps also persist in how DRESS may vary with region and ethnicity. The severity thresholds need validation in a revised multicenter statement.

DISCLOSURES:

The consensus review received no outside funding. Dr. Brüggen disclosed relationships with the Swiss National Science Foundation, Christine Kühne – Center for Allergy Research and Education, FreeNovation, LEO Foundation, Olga Mayenfisch Foundation, University of Zürich, LEO Pharma, Pierre Fabre Eczema Foundation, Eli Lilly, AbbVie, GSK, and AstraZeneca. Coauthors disclosed relationships with multiple pharmaceutical companies, foundations, and medical publishing companies.

A version of this article appeared on Medscape.com.