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this pageAccutane Label Revised to Reflect Drug’s Dangers
November 22, 2002 — Roche Laboratories, in cooperation with the Food and Drug Administration (FDA), has revised the safety labeling for the acne treatment drug isotretinoin (Accutane) to warn about its serious side–effects. These include psychiatric disorders, bone and fracture problems, and birth defects.
“Accutane may cause depression, psychosis ...suicide, and aggressive and/or violent behaviors,” according to the new label and a recent FDA Safety Alert. Since 1982, Accutane has been mentioned in 3,096 reports involving psychiatric disorders, including aggressive and violent behavior, 548 cases of depression, and 167 cases of suicide, an FDA spokesperson said (Newsday, November 12, 2002). The label recommends that physicians consult the brochure “Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Accutane” before dispensing Accutane to minors.
Accutane is not recommended for children with bone metabolism disorders or with a family background of osteoporosis. Even healthy children taking the drug may be at risk for injuries if they take part in sports with repetitive impact. Accutane has also been associated with back problems and joint pain (arthralgia).
If a woman becomes pregnant while taking Accutane, the risk is extremely high that her baby will be born with severe birth defects. These include skull, ear, and eye problems, and life–threatening brain and heart abnormalities. The risk of spontaneous abortion is also high. The new label contains a table showing the requirement for pregnancy testing for female patients of childbearing age who wish to take Accutane.
Generic Form of Isotretinoin Approved
Accutane is used for clearing up nodular or cystic acne, the most severe form of the skin condition. Because of Accutane’s side–effects, it is considered a last resort that is used after antibiotics fail.
Given the history of Accutane, it is surprising that the FDA recently approved a generic form of the drug. Bertek Pharmaceuticals Inc., a subsidiary of Mylan Laboratories, will market isotretinoin soft gelatin capsules under the trade name Amnesteem (Pittsburgh Business Times, November 11, 2002).
At Brayton Purcell, we will continue to keep up–to–date about medical drugs that may pose a threat to consumers. If you have any questions about unsafe drugs and your legal rights, please feel free to contact us.