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How Common Are Accutane-Related Psychiatric Events? | MedPage Today.Isotretinoin-Induced Delusional Disorder, Somatic Subtype
They found that attempted and completed suicide, suicidal ideation, and depression made up the bulk of the complaints, as expected. But they also found a surprising abundance of reports of conditions such as insomnia, anxiety disorders, emotional lability, and self-harm. The study was not designed to say whether isotretinoin treatment caused these effects, or even whether they were more common among isotretinoin patients than in the rest of the American population.
But Mostaghimi believes that the results are still worth considering. Isotretinoin is strictly controlled through an FDA program called iPledge, which requires patients to visit their dermatologist once a month in order to receive their prescription.
Isotretinoin can cause serious birth defects, so women capable of bearing children have to commit to using two methods of birth control while taking the drug and submit to monthly pregnancy tests. Dermatologists also commonly require their isotretinoin patients to get a monthly blood test. Mostaghimi hopes that dermatologists can take advantage of that monthly check-in to screen their patients for the less acknowledged conditions that he found reported in the FDA database.
But adding more screening demands on top of the existing iPledge requirements could be a nightmare for some patients. In its current iteration, iPledge can already create significant obstacles to acne treatment. According to Mostaghimi, the program has been grappling with how to handle the needs of transgender patients for a few years now.
To the best of our knowledge, this is the first case report of isotretinoin-induced delusional disorder, somatic type. It is a unique case, as it was an increase in the dosage of isotretinoin that triggered the psychotic episode and not the initiation of isotretinoin therapy.
In the majority of case reports, the patients had a past psychiatric history or a family history of mental illness. Whereas the patient presented here had no prodromal symptoms, no previous psychiatric history, and no family history of mental illness.
Approximately two weeks after discontinuing isotretinoin and starting quetiapine, the psychotic symptoms had resolved. The patient continued to take quetiapine for approximately two months prior to it being discontinued. He was followed by psychiatry for a total of 4 months prior to being discharged back to the care of his family physician.
He had no relapses following the discontinuation of isotretinoin. Psychiatrists are familiar with the physical side effects, such as extrapyramidal symptoms and metabolic syndrome, that can occur in patients on psychotropic drugs.
However, it is pertinent to consider that nonpsychotropic drugs commonly prescribed by other medical specialties may cause psychiatric side effects. Although no causal relationship between isotretinoin and psychopathology has been established, the numerous case reports, including the one presented here, support the association. Therefore, physicians must be aware of this relationship and monitor patients on isotretinoin for psychiatric symptoms and consider stopping the drug and providing appropriate psychiatric treatment as soon as possible.
Furthermore, any psychiatric side effect from isotretinoin treatment should be reported to permit better understanding of the incidence of psychotic symptoms with this treatment. Isotretinoin is being increasingly prescribed due to its effectiveness for acne. It is likely that we are going to see more isotretinoin-induced psychiatric side effects as a result of its frequent use. It is important that all patients taking isotretinoin be screened regularly by the prescribing physician for signs of depression, suicidal ideation, and psychosis.
It is also important that psychiatrists take a detailed history, including a medication history, so that a diagnosis of medication-induced psychosis, such as the one presented in this report, is not overlooked. Costa, E. Bagatin, A. Martimbianco et al. Brzezinski, K. Borowska, A. Chiriac, and J. Sanudo, K. Hassun, and E. Henry, C. Dormuth, B. Winquist et al. Kontaxakis, D. Skourides, P. Ferentinos, B. Havaki-Kontaxaki, and G. Bremner, K.
Shearer, and P. Deniz and C. Wysowski, M. Pitts, and J. In response to concerns about the drug's potential to cause miscarriage, inflammatory bowel disease, and psychiatric events , the FDA added a warning to its labeling in detailing the increased risks associated with the drug and in , a congressional hearing was held to evaluate its safety.
Although some anecdotal reports of increased rates of depression persisted, the American Academy of Dermatology backed the drug in , stating that the use of isotretinoin for severe nodular acne was "appropriate," as long as physicians were aware of its potential for psychiatric disturbance and monitored their patients carefully.
Mostaghimi and colleagues emphasized that an increased risk of suicidal ideation in patients with acne has been reported in prior studies , irrespective of treatment method. For their study, the researchers used the FDA's Adverse Event Reporting System and iPLEDGE , a risk management system launched by the agency in specifically for women of childbearing age due to the risk of birth defects if isotretinoin is taken during pregnancy.
They searched for all reported psychiatric events from to that were suspected to be related to isotretinoin. In total, 17, psychiatric events were reported across this time period, of which The distribution of events was split roughly evenly between males
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.
Abstract Isotretinoin, an active form of vitamin A, is the drug of last resort for the treatment of severe acne.
Although some anecdotal reports of increased rates of depression persisted, the American Academy of Dermatology backed the drug in , stating that the use of isotretinoin for severe nodular acne was "appropriate," as long as physicians were aware of its potential for psychiatric disturbance and monitored their patients carefully.
Mostaghimi and colleagues emphasized that an increased risk of suicidal ideation in patients with acne has been reported in prior studies , irrespective of treatment method. For their study, the researchers used the FDA's Adverse Event Reporting System and iPLEDGE , a risk management system launched by the agency in specifically for women of childbearing age due to the risk of birth defects if isotretinoin is taken during pregnancy.
They searched for all reported psychiatric events from to that were suspected to be related to isotretinoin. In total, 17, psychiatric events were reported across this time period, of which The distribution of events was split roughly evenly between males Mean age of those in the reports was Read: The best skin-care trick is being rich.
Adewole Adamson, a professor of internal medicine at the University of Texas at Austin and the web editor of JAMA Dermatology , is adamant that more people should have access to isotretinoin. Emmy Graber, the president of the Dermatology Institute of Boston, was similarly cautious about reading too much into the new results. Despite its apparent flaws, iPledge itself might be the best tool researchers have to figure out how much, if anything, can be blamed on the drug.
Mostaghimi hopes that states can experiment with adding and removing different elements from iPledge to see which interventions actually keep patients healthier. Disentangling the difficulties of having acne from the difficulties of being a teen from the difficulties of being on isotretinoin is a medical conundrum, but also a personal one.
In , right around the time I turned 16, I was prescribed isotretinoin for cystic acne. The acute misery passed after a few months, but it has haunted me since. Maybe something inherent in me brought it on. On some level, it might not matter: Even if I had known the exact psychological risk the drug poses, if it indeed poses any at all, I might not have acted any differently.
Still, it would be nice to know. It is being increasingly prescribed for severe acne, as well as other skin conditions. Despite many documented psychiatric side effects [ 1 , 7 — 13 ], the etiology of isotretinoin-induced psychosis remains poorly understood. Though, it has been previously reported that an excess of dietary vitamin A induces psychosis [ 17 ]. Furthermore, in patients with psychosis, isotretinoin is contraindicated as it worsens the course of the disease [ 18 ].
To the best of our knowledge, this is the first case report of isotretinoin-induced delusional disorder, somatic type. It is a unique case, as it was an increase in the dosage of isotretinoin that triggered the psychotic episode and not the initiation of isotretinoin therapy.
In the majority of case reports, the patients had a past psychiatric history or a family history of mental illness. Whereas the patient presented here had no prodromal symptoms, no previous psychiatric history, and no family history of mental illness.
Approximately two weeks after discontinuing isotretinoin and starting quetiapine, the psychotic symptoms had resolved.
The patient continued to take quetiapine for approximately two months prior to it being discontinued. He was followed by psychiatry for a total of 4 months prior to being discharged back to the care of his family physician. He had no relapses following the discontinuation of isotretinoin. Psychiatrists are familiar with the physical side effects, such as extrapyramidal symptoms and metabolic syndrome, that can occur in patients on psychotropic drugs. However, it is pertinent to consider that nonpsychotropic drugs commonly prescribed by other medical specialties may cause psychiatric side effects.
Although no causal relationship between isotretinoin and psychopathology has been established, the numerous case reports, including the one presented here, support the association. Therefore, physicians must be aware of this relationship and monitor patients on isotretinoin for psychiatric symptoms and consider stopping the drug and providing appropriate psychiatric treatment as soon as possible. Furthermore, any psychiatric side effect from isotretinoin treatment should be reported to permit better understanding of the incidence of psychotic symptoms with this treatment.
Isotretinoin is being increasingly prescribed due to its effectiveness for acne. It is likely that we are going to see more isotretinoin-induced psychiatric side effects as a result of its frequent use. It is important that all patients taking isotretinoin be screened regularly by the prescribing physician for signs of depression, suicidal ideation, and psychosis.
It is also important that psychiatrists take a detailed history, including a medication history, so that a diagnosis of medication-induced psychosis, such as the one presented in this report, is not overlooked. Costa, E. Bagatin, A. Martimbianco et al. Brzezinski, K. Borowska, A. Chiriac, and J. Sanudo, K. Hassun, and E. Henry, C. Dormuth, B. Winquist et al.
Kontaxakis, D. Skourides, P. Ferentinos, B. Havaki-Kontaxaki, and G. Bremner, K.
While use of isotretinoin Accutane has frequently been linked with psychiatric adverse events, the rate of completed suicides among those taking the acne medication may be lower than in the general population, a retrospective analysis found.
Over the past two decades, nearly 18, cases of depression, anxiety, and emotional lability linked to isotretinoin use were reported to the FDA, including 2, cases of suicidal ideation, cases of attempted suicide, and reports of completed suicide, reported Arash Mostaghimi, MD, MPA, MPH, of Brigham and Women's Hospital in Boston, and colleagues. In andrespectively, 8. Although some clinicians recognize isotretinoin as the "gold standard" for treating severe acnethe drug came under the media spotlight after numerous cases of depression, suicide, and other psychiatric affects were reported in the decade following its approval in In response to concerns about the drug's potential to cause miscarriage, inflammatory bowel disease, and psychiatric eventsthe FDA added a warning to its labeling in detailing the increased risks associated with the drug and ina congressional hearing was held to evaluate its safety.
Although some anecdotal reports of increased rates of depression persisted, the American Academy of Dermatology backed the drug instating that the use of isotretinoin for severe nodular acne was "appropriate," as long as physicians were aware of its potential for psychiatric disturbance and monitored their patients carefully. Mostaghimi and colleagues emphasized that an increased risk of suicidal ideation in patients with acne has been reported in prior studiesirrespective of treatment method.
For their study, the researchers used the FDA's Adverse Event Reporting System and iPLEDGEa risk management system launched by the agency in specifically for women of childbearing age due to the risk of birth defects if isotretinoin is taken during pregnancy. They searched for all reported psychiatric events from to that were suspected to be related to isotretinoin.
In total, 17, psychiatric events were reported across this time period, of which The distribution of events was split roughly evenly between males Mean age of those in the reports was Although suicide ideation and attempt rates were split about evenly between sexes, the majority of individuals to die from suicide were men Those ages 10 to 19 accounted for a larger proportion of suicides than individuals in their 20s or 30s In fact, the majority of psychiatric events overall occurred in teenagers, which could indicate that this group is "particularly vulnerable to psychiatric adverse events while taking isotretinoin," or simply that they are more frequently prescribed it, the authors noted.
Lastly, although males and females had similar rates of depression They noted certain limitations of the research, such as the fact that certain events like suicides likely have a higher chance of being reported than anxiety or emotional lability.
Elizabeth Hlavinka covers clinical news, features, and investigative pieces for MedPage Today. She also produces episodes for the Anamnesis podcast. Sign Up. Career Center. Mostaghimi reported fees from Pfizer outside the submitted work.
localhost › Dermatology › General Dermatology. Isotretinoin has been associated with psychiatric disorders and symptoms beyond depression and psychosis in some cases. In 1 instance, a year.
Accutane is already controversial for its possible links to depression. It could also have a range of other effects. A brochure for the program also warns that the drug “may cause serious mental health problems” including depression, psychosis, and suicide. Since its introduction, isotretinoin has been linked with various psychiatric side effects. In particular, depression and suicidality have been.
Conclusion Isotretinoin is being increasingly prescribed due to its effectiveness for acne. Isotretinoin is being increasingly prescribed for severe acne, as well as moderate acne and other skin conditions, including seborrhea, seborrheic dermatitis, and scarring [ 134 ]. Pitts, and J. Here, we report a case of isotretinoin-induced psychosis, which was diagnosed as delusional disorder somatic subtype, in a young male in the absence of any prodromal symptoms, previous psychiatric history, or family history of mental illness. Ina family filed a lawsuit alleging that an acne drug made their teenage son suicidal. The electroencephalogram EEG was reported within normal limits as no focal abnormalities nor epileptic activities were identified. His drug urine screen was negative for illicit substances, including benzodiazepines.
In , a family filed a lawsuit alleging that an acne drug made their teenage son suicidal. But since the FDA approved isotretinoin in , it had been plagued by controversy over whether it could alter brain chemistry and cause depression.
The case was dropped in Meanwhile, a steady stream of research has continued to probe the question of whether isotretinoin causes depression and suicide. None of it has conclusively proved an answer. But a study published today in JAMA Dermatology contends that, for all the focus on these most dramatic side effects, dermatologists and psychiatrists might have overlooked other potential mental-health risks for patients taking the drug.
They found that attempted and completed suicide, suicidal ideation, and depression made up the bulk of the complaints, as expected. But they also found a surprising abundance of reports of conditions such as insomnia, anxiety disorders, emotional lability, and self-harm.
The study was not designed to say whether isotretinoin treatment caused these effects, or even whether they were more common among isotretinoin patients than in the rest of the American population. But Mostaghimi believes that the results are still worth considering. Isotretinoin is strictly controlled through an FDA program called iPledge, which requires patients to visit their dermatologist once a month in order to receive their prescription. Isotretinoin can cause serious birth defects, so women capable of bearing children have to commit to using two methods of birth control while taking the drug and submit to monthly pregnancy tests.
Dermatologists also commonly require their isotretinoin patients to get a monthly blood test. Mostaghimi hopes that dermatologists can take advantage of that monthly check-in to screen their patients for the less acknowledged conditions that he found reported in the FDA database. But adding more screening demands on top of the existing iPledge requirements could be a nightmare for some patients. In its current iteration, iPledge can already create significant obstacles to acne treatment.
According to Mostaghimi, the program has been grappling with how to handle the needs of transgender patients for a few years now. And a study he published in March found that nonwhite isotretinoin patients were about 50 percent more likely to end their treatment early than their white counterparts—and that patients were most likely to identify iPledge-related requirements as the reason they delayed or interrupted their treatment.
The FDA declined to comment on the new paper. Read: The best skin-care trick is being rich. Adewole Adamson, a professor of internal medicine at the University of Texas at Austin and the web editor of JAMA Dermatology , is adamant that more people should have access to isotretinoin.
Emmy Graber, the president of the Dermatology Institute of Boston, was similarly cautious about reading too much into the new results. Despite its apparent flaws, iPledge itself might be the best tool researchers have to figure out how much, if anything, can be blamed on the drug.
Mostaghimi hopes that states can experiment with adding and removing different elements from iPledge to see which interventions actually keep patients healthier. Disentangling the difficulties of having acne from the difficulties of being a teen from the difficulties of being on isotretinoin is a medical conundrum, but also a personal one.
In , right around the time I turned 16, I was prescribed isotretinoin for cystic acne. The acute misery passed after a few months, but it has haunted me since. Maybe something inherent in me brought it on. On some level, it might not matter: Even if I had known the exact psychological risk the drug poses, if it indeed poses any at all, I might not have acted any differently.
Still, it would be nice to know. Skip to content Site Navigation The Atlantic. Popular Latest Newsletters. Search The Atlantic. Quick Links. Sign In Subscribe.
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