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Please provide an update on the known side effects of isotretinoin (Accutane). How conclusive are studies linking isotretinoin use with depression and suicidal ideation? Given the drug's adverse effects, when is a prescription appropriate and what factors should be discussed with an adolescent patient?
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In 1982, the FDA approved the use of oral isotretinoin as a treatment for severe, recalcitrant nodulocystic acne vulgaris. Dr. Thomas Fitzpatrick, one of the American fathers of modern dermatology, used to say that isotretinoin was one of the true medical miracles. More than 20 years and billions of dollars of acne research later, there is still nothing like it for the most severe cases.
For such a powerful medication, isotretinoin is surprisingly safe. Common side effects include the inevitable dry skin, dry irritated lips (cheilitis) and dry eyes. Some patients have mild arthralgias and myalgias and some can have a reversible hair loss. Monthly blood tests are required for some of the more serious adverse effects, including elevated transaminases,
hypertriglyceridemia, and of course, severe birth defects.
In 2000, Congressman Bart Stupak's son died of a self-inflicted gunshot wound while on Accutane. This sparked a powerful movement to restrict and possibly remove isotretinoin from the market. While there have been no
conclusive studies showing a causative effect, there is anecdotal data
suggesting that, at least in some individuals, isotretinoin may be associated with depression and suicidal ideation. Interestingly, there are several studies that show the exact opposite effect: that patients taking isotretinoin for acne are happier, likely secondary to the improvement of their severe, disfiguring acne. All of these studies are small, however, and are not optimized for
finding a potentially rare, idiosyncratic side effect with this medication. Further increasing the complexity of the problem is the fact that this tends to happen in teens who have the potential to be incredibly emotionally labile and who have higher levels of suicidal ideation and suicidality at baseline.
With the new federally mandated iPLEDGE system, it's become much more difficult to prescribe isotretinoin. The prescriber, pharmacist and patient must all sign off every 30 days on counseling and lab testing before the
medication can be dispensed. This rigidity alone makes it difficult for some patients to use, and must be discussed at length before starting the treatment.
Depression and suicidality are very rare side effects of isotretinoin, if they are related at all. However, it seems safe to say that this must become part of the discussion and risk-benefit calculation when giving this medication. Given the gravity of these possible risks, isotretinoin is best used only by a
dermatologist and only for severe, scarring, refractory acne that has failed other topical and systemic medications. It must be used with "eyes wide open" to these more speculative possibilities and to as-of-yet uncertain possibilities, such as inflammatory bowel disease. For patients who understand these rare but frightening risks, isotretinoin remains a wonderful medication that can actually cure disfiguring acne and make them incredibly happy.
—Peter Lio, MD
Staff physician in Dermatology
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