The Food and Drug Administration (FDA) and Roche Laboratories have added to the already long list of warnings for isotretinoin, a powerful acne medication. Other possible Accutane side effects include serious birth defects and fetal death. The drug is best known by its brand name Accutane; the FDA approved a generic version, to be called Amnesteem, in early November.
The new warning language says: “Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors.
Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary. No mechanism of action has been established for these events.” That statement, along with all the other cautions, will be required for the generic version, according to the FDA.
According to MedWatch, an FDA-administered safety information program, the warnings were the result of “post-marketing safety reports.” In 1998, the FDA warned Hoffman-La Roche Inc. that its promotional materials for Accutane contained false and misleading information, specifically that Accutane was effective in the treatment of “psychosocial trauma” connected with severe acne. The agency also identified 20 instances in which a person’s depression resolved when he or she stopped taking Accutane, but recurred when the use of the drug was resumed.
Perhaps the most notorious incident involving Accutane concerns a suicide in early January, when a 15-year-old boy flew a small plane into a skyscraper in Tampa, Fla. The boy’s family filed a wrongful-death Accutane lawsuit against Hoffman-La Roche Inc., charging that the drug caused him to become severely psychotic. The suit is still pending. The FDA’s Center for Drug Evaluation and Research has information on its web site to help people recognize psychiatric disorders in adolescents and young adults who may be taking Accutane.