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Health Canada says Accutane may cause potentially deadly skin reactions

The Canadian Press (2/17) reports that in an advisory released on Feb. 16, Health Canada warned "consumers that rare but potentially deadly skin reactions have been reported with the use of Accutane [isotretinoin] for the treatment of severe acne." In the advisory, Health Canada "said there have been 'very rare' reports of severe skin reactions linked to Accutane that can result in hospitalization, disability, or even death." The agency "said anyone currently taking or recently on Accutane should stop the drug and see their doctor immediately" if they develop a rash with fever, blisters on their face and limbs, mouth or throat sores, and "peeling skin."

Dr. Rosio's Opinion:

The press can sensationalize or take out of context medical information. Recent news reports in the U.S. and Canada, including a sensationalized case in New Jersey prompt the question: Is Accutane a significant cause of Inflammatory Bowel Disease or severe alllergic reactions?   

My opinion including Accutane/Isotretinoin and many other drugs is a qualified no. While any dermatologic drug including Accutane can have adverse effects if not used properly with your dermatologist's diagnosis and management, Accutane and it's generics remain safe and effective.

Why the controversy? Companies are required by the FDA to report side effects that may occur coincidentally, even if not known to be caused by their drug, as though their drug is a direct cause. The use of some drugs may help one condition, i.e. Acne, Darier's Disease, Lymphomas, but may reveal, cause irritation or aggravation of a previously undiagnosed or silent problem, allowing it to be diagnosed at that time.

Presently, whether Inflammatory Bowel Disease is caused or merely coincidental or aggravated is still controversial. But the majority of Accutane users, even with years and years of use never have IBD. I've never seen it in ANY of my patients, even those on chronic long-term Accutane use. And Canada's mention of "rare" allergic reaction similar to "Stevens-Johnson Syndrome" is so rare, I don't even know another dermatologist who's ever heard of it in relation to Accutane.

So there you have it. You needn't be alarmed. Just informed. Please let me know if you have any further concerns about this news.