Accutane Warnings Extend to Generic Versions

Seattle, WAAlthough Accutane is no longer on the market, generic versions of the acne medication are still available. These medications—Claravis, Amnesteem and Sotret—are generic forms of isotretinoin, a synthetic version of vitamin A. While generic, they still come with warnings about inflammatory bowel disease and potential for birth defects.


According to the warning for Claravis, found at ipledgeprogram.com, "Claravis has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders." The warning notes that in some cases, symptoms of inflammatory bowel disease persisted after Claravis treatment was stopped.

Patients who take Claravis are also required to sign on to the iPLEDGE program, and women who are or may become pregnant are not to use the medication. Women who are of childbearing age must agree to use two forms of contraception or to abstain from sexual activity.

Although the warning label for Amnesteem (found at ipledgeprogram.com) does not specifically mention inflammatory bowel disease, it does warn that certain symptoms may mean the patient's organs are being damaged, including the intestines. The warning further states that organ damage may persist after Amnesteem treatment is stopped.

Patients who take Amnesteem must sign the iPLEDGE form because of the risk of birth defects, miscarriage and premature births.

Similar to Amnesteem, the warning label for Sotret (found at ipledgeprogram.com) does not specifically mention inflammatory bowel disease, but does warn about a risk of damage to internal organs.

Patients who are taking any form of isotretinoin and develop symptoms of bowel disease, including severe stomach, chest or bowel pain, diarrhea or rectal bleeding, are urged to stop taking the medication and contact their doctor immediately.

Sotret is manufactured by Ranbaxy Laboratories Inc. Amnesteem is manufactured by Mylan Pharmaceuticals and Claravis is manufactured by Barr Laboratories. Accutane was manufactured by Roche Holding before it was pulled from the market in June 2009.

Patients who took Accutane or any generic versions of the drug and suffer symptoms of inflammatory bowel disease should see a doctor for a diagnosis. Even patients who took Accutane years ago may experience symptoms of inflammatory bowel disease without knowing that it is linked to use of Accutane. In some situations, patients go years without making the connection.