Evidence of increased risk for suicide and inflammatory bowel disease in patients treated with isotretinoin is not strong enough for physicians to stop prescribing the drug to treat severe acne, according to the American Academy of Dermatology.
In a position statement, the academy said that psychiatric studies of patients taking isotretinoin have suggested mental health benefits as well as risks. Anecdotal reports have suggested increased risk of psychosis, depression, and suicidal ideation and behavior in patients treated with isotretinoin.
The academy's statement also said that "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."
"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," the statement added.
The best-known branded form of isotretinoin, Accutane, was withdrawn from the U.S. market in 2009. However, generic versions are still sold and their labels do list these psychiatric conditions as potential adverse reactions to the drug.
The dermatology group issued the statement in the wake of a recent study that linked the increased suicide risk with acne rather than isotretinoin treatment, although it did not fully absolve the drug.
In its position statement, the group asserted that "there is sufficient evidence for the use of isotretinoin in severe forms of acne, particularly (but not limited to) severe recalcitrant nodular acne or acne which has proven refractory to other forms of therapy."
It also backed the off-label use of isotretinoin for cornification and chemoprevention of skin cancer in high-risk patients -- though the statement also called on physicians to tell patients that such uses are not FDA-approved.
"The Association concludes that the prescription of isotretinoin for severe nodular acne continues to be appropriate as long as prescribing physicians are aware of the issues related to isotretinoin use, including IBD or psychiatric disturbance, and educate their patients about these and other potential risks. Physicians also should monitor their patients for any indication of IBD and depressive symptoms," the group concluded.