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The use of isotretinoin therapy in dermatology has become complicated by regulatory and medicolegal issues. Still, isotretinoin for severe acne has been a mainstay of dermatologic therapy since its Food and Drug Adminstration approval in 1982. While dermatologists have become adept at addressing the drug's well-known teratogenic adverse effects and potential associations with depression and suicidal ideation, a knowledge gap may exist for many dermatologists to address clinical care questions related to isotretinoin therapy and IBD. The article by Popescu and Popescu1 in this issue of Archives helps to narrow this gap and potential knowledge gaps related to general epidemiologic principles about causation.
If not for the significant and consistent therapeutic benefits, isotretinoin would not likely be prescribed because the regulatory and medicolegal issues surrounding isotretinoin prescribing are time consuming and always looming. Recent and continued lawsuits related to isotretinoin therapy and IBD highlight the need for dermatologists to educate themselves and to provide consistent patient education on current evidence related to therapeutic risks while also addressing benefits and alternatives as they strive to provide exceptional care to their patients. The article by Popescu and Popescu1 provides us with the helpful clinical perspective that 2977 patients would need to be treated to get one result of ulcerative colitis (the “number needed to harm”). Specific behavior changes might include more attention to a review of systems relative to symptoms of IBD (eg, abdominal cramps and pain, bloody diarrhea, weight loss, or loss of appetite) and a medical history that includes personal and family histories of ulcerative colitis.
Barriers to closing this knowledge gap include lack of time, concern about medicolegal issues, and a feeling of helplessness when it comes to understanding statistics and epidemiologic principles. While there are position papers about isotretinoin, the Canadian version does not mention IBD2 and the American Academy of Dermatology position statement states:
Current evidence is insufficient to prove either an association or a causal relationship between isotretinoin use and inflammatory bowel disease (IBD) in the general population. While some recent studies have suggested such a relationship, further studies are required to conclusively determine if the association or causal relationship exists and/or whether IBD risk may be linked to the presence of severe acne itself.3
As evidence of the rapid evolution of this issue, the acne treatment guidelines published in 2007 make no mention of IBD relative to isotretinoin therapy.4
With straightforward review of the salient studies related to isotretinoin therapy and IBD, it is clear that there are concerns that should be discussed with patients, but these concerns are really not different from the many known and unknown risks associated with many more commonly prescribed medications. Once the responsibility of being someone's physician is assumed, the physician is obligated to do his or her best to inform and educate his or her patients, but there are always potential outcomes that cannot be predicted (risks) that go with the hopeful outcome of therapeutic success (benefit). In my practice, I often apologize that “my crystal ball is broken,” but I will do my best to tell the patient and family what I know. I genuinely encourage patients to read and discuss their concerns with me, although this does make for some added conversations. The Popescu et al article will narrow a clinical practice gap and prove beneficial to all clinicians who prescribe isotretinoin while potentially assisting patients also trying to understand their risks.
Correspondence: Dr Mostow, Division of Internal Medicine, Dermatology Section and Dermatology, Northeastern Ohio Universities Colleges of Medicine and Pharmacy, Case Western Reserve College of Medicine, 157 W Cedar St, Ste 101, Akron, OH 44307 (emostow@neoucom.edu).
Financial Disclosure: None reported.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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