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Accutane anxiety and depression.Acne’s Wonder Drug Is a Mental-Health Puzzle
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.
❾-50%}Accutane anxiety and depression -
Isotretinoin Roaccutane is an extremely effective anti-acne preparation. Symptoms resolve rapidly within days on discontinuation of the medicine. After a period off medication, it is worthwhile recommencing therapy at a lower dose. A spectrum of central nervous system side effects, similar to that observed with hypervitaminosis A syndrome, 1 can be induced with synthetic retinoids such as isotretinoin Roaccutane and neotigason Acitretin.
At July , the Centre for Adverse Reactions Monitoring CARM database held 9 reports of depression or symptoms of depression with isotretinoin 5 severe, 4 mild , although one case was considered unlikely to be associated with the drug. The symptoms were somnolence, aggressiveness, dizziness, depersonalisation, abnormal behaviour, fatigue, and personality disorder.
Recurrence occurred in the 2 cases that were rechallenged. The depression subsides with discontinuation of isotretinoin, but may recur with reinstitution of therapy. These data must be considered in the context of our study design, which is based on the Adverse Event Reporting System database. These data are limited by reliance on proper reporting by clinicians, although reporting of serious events, such as suicide, may be more likely than reporting of less severe outcomes.
In addition, although we separated some psychiatric reaction terms, including emotional lability and insomnia, into their own categories, we recognize these may represent symptoms of other psychiatric diagnoses such as depression, anxiety, or bipolar disorder. Depressive disorders and suicidality were the most frequently reported adverse events associated with isotretinoin use, but these reports must be considered in the context of elevated rates of depression and suicide among patients with acne.
Our study suggests that the rate of completed suicide in patients taking isotretinoin may be lower than that of the general US population, but further study is necessary to assess the rate of completed suicide in this population. Mandated monthly visits under the current iPLEDGE infrastructure may provide an opportunity to screen patients for psychiatric conditions and improve patient outcomes.
Published Online: July 3, Mr Singer and Dr Mostaghimi had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Acquisition, analysis, or interpretation of data: Singer, Tkachenko, Sharma, Barbieri. Critical revision of the manuscript for important intellectual content: Singer, Tkachenko, Sharma, Barbieri.
Conflict of Interest Disclosures: Dr Mostaghimi reported receiving personal fees from Pfizer and personal fees from hims outside the submitted work.
No other disclosures were reported. Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy Continue. Table 1. View Large Download. Table 2. Table 3. Table 4. Isotretinoin treatment for acne and risk of depression: a systematic review and meta-analysis. J Am Acad Dermatol. Acne drug maker sued over Florida suicide.
New York Times. Published April 16, Accessed March 24, Depression and suicide in patients treated with isotretinoin. N Engl J Med. Accessed May 31, An analysis of reports of depression and suicide in patients treated with isotretinoin. Adverse effects of isotretinoin: a large, retrospective review. Dermatol Ther. More eyeballs on AERS. Nat Biotechnol. Dermatologic and Opthalmic [sic] Drugs Advisory Committee. Published Accessed December 16, Centers for Disease Control and Prevention.
Last reviewed March 21, Accessed January 13, Accutane killed my son. CBS News. Published October 5, Accessed February 24, Dixon H.
Controversial acne drug blamed for a number of suicides. Published July 4, Risk of depression among patients with acne in the U.
Br J Dermatol. Acne, anxiety, depression and suicide in teenagers: a cross-sectional survey of New Zealand secondary school students. J Paediatr Child Health. 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.
Information on this subject has been updated. Read the most recent information. Isotretinoin Roaccutane is an extremely effective anti-acne preparation. Symptoms resolve rapidly within days on discontinuation of the medicine. After a period off medication, it is worthwhile recommencing therapy at a lower dose. A spectrum of central nervous system side effects, similar to that observed with hypervitaminosis A syndrome, 1 can be induced with synthetic retinoids such as isotretinoin Roaccutane and neotigason Acitretin.
At Julythe Centre for Adverse Reactions Monitoring CARM database held 9 reports of depression or symptoms of depression with isotretinoin 5 severe, 4 mildalthough one case was considered unlikely to be associated with the drug. The symptoms were somnolence, aggressiveness, dizziness, depersonalisation, abnormal behaviour, fatigue, and personality disorder. Recurrence occurred in the 2 cases that were rechallenged. The depression subsides with discontinuation of isotretinoin, but may recur with reinstitution of therapy.
Acute, severe depression, on the other hand, is more obvious although fortunately much less common. Two of the seven patients had a prior history of depression. The symptoms of depression occurred during the first course of isotretinoin in five patients, and in the second or third course in the remaining two patients. The seven patients voluntarily reported the following characteristic symptoms of a major depressive episode: fatigue 5irritability 4decreased concentration 4sadness 4crying spells 3loss of motivation 3forgetfulness 2suicidal ideation 1anhedonia 1 abnormal dreams 1 and fear of going insane 1.
All symptoms resolved within 2 to 7 days of discontinuing the medicine. One patient was rechallenged several months later, with recurrence of the depressive symptoms during the third month of his second course of therapy.
Isotretinoin should be discontinued in patients who develop symptoms of a major depressive episode. After a period of time, it may be worthwhile rechallenging the patient with a smaller dose. If symptoms recur, either the medicine should be discontinued or the patient treated with a selective serotonin reuptake inhibitor.
This adverse effect of isotretinoin needs, however, to be placed into context. Many patients with acne demonstrate symptoms of anxiety and depression which can range from psychological distress to psychiatric morbidity. Isotretinoin is an extremely effective anti-acne treatment, and it is therefore not surprising that in most cases there is a significant reduction in both anxiety and depressive symptoms following successful treatment with isotretinoin.
The side effects of isotretinoin are likely to be a class effect, so one would expect to see similar problems with other retinoids used for non-dermatological indications. There have been no reports of depression following use of topical retinoids.
We talk to experts to understand the risks and benefits of isotretinoin, which is renowned for being in Accutane acne medication before it. Isotretinoin (cis-retinoic acid, marketed under the names Accutane, Roaccutane, and others) is an effective treatment for acne that has been. Acne treatment including the highly effective acne medication isotretinoin should be made more readily available despite reports of its. In , a family filed a lawsuit alleging that an acne drug made their teenage son suicidal. Accutane, a since-discontinued brand name for. Although the drug isotretinoin can lead to significant improvement for individuals with severe acne, mood disorders — including depression and. Add or change institution.JAMA Dermatol. Question What numbers and types of psychiatric adverse events associated with isotretinoin use are reported to the US Food and Drug Administration? Depressive disorders, emotional lability, and anxiety disorders were most commonly reported. Meaning Although adverse event reports submitted to the US Food and Drug Administration indicated that patients taking isotretinoin experienced psychiatric adverse effects, further research is required to determine whether exposure to isotretinoin was causal.
Importance Isotretinoin is a highly effective medication for severe acne. Although no causal link between isotretinoin and psychiatric adverse effects has been established, widespread media reporting of depression and suicidality with use of isotretinoin have raised concerns in both patients and clinicians and generated numerous cases of costly litigation. Objective To evaluate reports of psychiatric adverse events associated with isotretinoin use submitted to the US Food and Drug Administration from January 1, , through December 31, All data were analyzed between July 1, , and January 31, Main Outcomes and Measures The main outcomes were frequency and type of psychiatric adverse events in patients taking isotretinoin.
Secondary analyses were stratification by age and sex and evaluation of completed suicide rates. Of these events, More than half Whereas depression and anxiety were reported equally between sexes, eating disorders were more common in females 58 of 85 [ The rates of completed suicide were 8.
Conclusions and Relevance Although depressive disorders and suicidality were frequently reported with isotretinoin use, these reports must be considered in the context of elevated rates of depression and suicide among patients with acne at large.
These data suggest that the rate of completed suicide in patients taking isotretinoin may be lower than that of the general US population. Many psychiatric adverse events unrelated to depression and suicidality were also reported, but it is unclear if they were a result of isotretinoin therapy. Although no causal link between isotretinoin and psychiatric risk has been established, patients taking the drug appear vulnerable to psychiatric concerns.
Mandated monthly iPLEDGE visits may provide an opportunity to screen patients for psychiatric conditions and improve outcomes. Isotretinoin is a highly effective medication for severe refractory acne. Since its approval by the US Food and Drug Administration FDA in , isotretinoin has been linked to reports of depression, suicide, and other psychiatric effects, leading to both widespread media coverage and numerous cases of costly litigation.
Although one study highlighted consistent reporting of depression and suicide in patients taking isotretinoin in the United States from to , few studies have examined reports of psychiatric adverse events at the national level since The FDA compiles reports of adverse events submitted by clinicians, pharmacists, and patients in a publicly available database known as the Adverse Event Reporting System. These reports are entered using a coding thesaurus of reaction terms.
For this retrospective analysis, we accessed these data using FDAble, a search engine for querying the database. Males and females who are not of childbearing potential must also visit their physician monthly to confirm proper use of the medication.
Because the data used in this study are publicly available, the project was deemed exempt by the Partners Healthcare Institutional Review Board, which also waived the need for patient informed consent because the data were deidentified. We performed a retrospective study of reports in the Adverse Event Reporting System of psychiatric adverse events with isotretinoin as the primary suspect drug in the United States from to We identified 49 discrete psychiatric reaction terms and, given the high redundancy between them, classified the terms into 12 broader adverse event categories AECs Table 1.
Twelve reaction terms, accounting for When multiple reaction terms from the same AEC were reported for a single individual, that individual was counted only once in the AEC to prevent duplicate reports.
Age- and sex-specific analyses excluded reports without an associated age or sex, respectively. We used Python software, version 3. Depressive disorders [ In addition, there were reports of suicidal ideation, reports of attempted suicide, and reports of completed suicide.
Depression and anxiety were reported equally between the sexes, with females representing Sex differences were apparent in eating disorder Although males accounted for Among these reports, the to year-old age group accounted for The to year-old age group had completed suicides, accounting for In and , there were 21 and 11 completed suicides, respectively Table 4 , indicating a rate of 8.
We evaluated reports to the FDA of depressive disorders, suicidality, and other psychiatric adverse events with isotretinoin as the primary suspect drug from through Depressive disorders and suicidal ideation accounted for In addition, completed suicides were reported to the FDA, with men accounting for This sex-specific disparity is consistent with national statistics on completed suicide, which is more common in men.
Suicidality is one of the most discussed potential adverse events associated with isotretinoin, having received substantial media attention over the past few years. These rates are lower than reported national suicide rates in the United States for these years, which were The risk of psychiatric adverse events in patients taking isotretinoin must be considered in the context of a known increased risk of suicidal ideation in patients with acne independent of isotretinoin therapy.
As such, the risk of depression and suicidality in patients taking isotretinoin may be associated more with the burden of acne itself than with its treatment. Although depression and suicidality are noted potential adverse events of isotretinoin, our results suggest that other, underappreciated psychiatric adverse events may be linked to its use.
Our data showed high numbers of reports of emotional lability, anxiety disorders, insomnia, self-injurious behavior, and psychotic disorders with isotretinoin as the primary suspect drug. Although no causal link has been established between isotretinoin and psychiatric adverse events, it is important to recognize that there are data that suggest patients using this drug may be vulnerable to a number of psychiatric conditions.
Our study builds on prior papers that have called for use of Patient Health Questionnaire-2 or Patient Health Questionnaire-9 to screen for depression in patients taking isotretinoin, 23 - 25 and we also advocate for the integration of these screening tools into the existing iPLEDGE infrastructure.
These changes to the iPLEDGE system should be evaluated prospectively and in a randomized fashion to determine the benefits vs burdens of an expanded intervention. Improved prospective data collection on top of the existing iPLEDGE infrastructure may shed light on the epidemiology and psychiatric risks of patients taking isotretinoin and determine whether monthly screening is beneficial.
Ultimately, although the relationship between severe acne, isotretinoin, and depression has not been firmly established, clinicians should take advantage of monthly appointments to assess patients for psychiatric comorbidity regardless of the root cause. These data must be considered in the context of our study design, which is based on the Adverse Event Reporting System database.
These data are limited by reliance on proper reporting by clinicians, although reporting of serious events, such as suicide, may be more likely than reporting of less severe outcomes. In addition, although we separated some psychiatric reaction terms, including emotional lability and insomnia, into their own categories, we recognize these may represent symptoms of other psychiatric diagnoses such as depression, anxiety, or bipolar disorder. Depressive disorders and suicidality were the most frequently reported adverse events associated with isotretinoin use, but these reports must be considered in the context of elevated rates of depression and suicide among patients with acne.
Our study suggests that the rate of completed suicide in patients taking isotretinoin may be lower than that of the general US population, but further study is necessary to assess the rate of completed suicide in this population.
Mandated monthly visits under the current iPLEDGE infrastructure may provide an opportunity to screen patients for psychiatric conditions and improve patient outcomes. Published Online: July 3, Mr Singer and Dr Mostaghimi had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Acquisition, analysis, or interpretation of data: Singer, Tkachenko, Sharma, Barbieri.
Critical revision of the manuscript for important intellectual content: Singer, Tkachenko, Sharma, Barbieri. Conflict of Interest Disclosures: Dr Mostaghimi reported receiving personal fees from Pfizer and personal fees from hims outside the submitted work. No other disclosures were reported. Our website uses cookies to enhance your experience.
By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy Continue. Table 1. View Large Download. Table 2. Table 3. Table 4.
Isotretinoin treatment for acne and risk of depression: a systematic review and meta-analysis. J Am Acad Dermatol. Acne drug maker sued over Florida suicide. New York Times. Published April 16, Accessed March 24, Depression and suicide in patients treated with isotretinoin. N Engl J Med. Accessed May 31, An analysis of reports of depression and suicide in patients treated with isotretinoin.
Adverse effects of isotretinoin: a large, retrospective review. Dermatol Ther. More eyeballs on AERS. Nat Biotechnol. Dermatologic and Opthalmic [sic] Drugs Advisory Committee. Published Accessed December 16, Centers for Disease Control and Prevention. Last reviewed March 21, Accessed January 13, Accutane killed my son. CBS News. Published October 5, Accessed February 24,
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