Safety Alerts & Recalls

What does this mean?

Isotretinoin has numerous safety concerns that are well known by physicians with experience in the treatment of severe acne. According to the prescribing information, successful treatment more closely related to the total dose administered than to either duration of treatment or daily dose.

This alert provides a reminder to patients that it is very important to report any side effects or concerning symptoms to your physician during your regular visits. If you have been taking an isotretinoin product for a long time, you may wish to discuss with your doctor the benefits and risks of continued use.

Long-term Use of Isotretinoin Linked to Increased Risk of Ulcerative Colitis

A recent study published in the American Journal of Gastroenterology found a possible association between use of isotretinoin and development of ulcerative colitis, a disease that causes ulcers in the lining of the rectum and colon. Overall, the increased risk of ulcerative colitis associated with isotretinoin was small. The long-term use of isotretinoin for 2 or more months was a risk factor for development of ulcerative colitis.

Isotretinoin is commonly prescribed for the treatment of severe acne. It is sold under the brand names Isotrex, Isotrexin, and Roaccutane.

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Source: MediGuard CRT
Publication Date: 2010-06-18
Last Updated: 2010-11-08

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