FDA: New consumer warnings on Accutane, including possible suicide riskDec 6, 2000 | AP
Patients who take the powerful acne drug Accutane will soon get special warning brochures outlining side effects -- including a possible, but not proven, link to suicide. Patients must then sign a paper certifying they understand those risks, health officials told Congress Tuesday.
The MedGuide warning brochures, attached to every bottle sold -- along with tougher patient informed-consent forms -- may be distributed as early as next month, said Dr. Jonca Bull, the Food and Drug Administration's deputy drug chief.
Also, the FDA is developing tougher restrictions on who can take Accutane and which doctors can prescribe it, Bull told the House Government Reform Committee. This so-called registry is an attempt to counter another Accutane problem: 2,000 women have gotten pregnant while taking Accutane since the drug began selling in 1982. The drug is known to cause severe Accutane birth defects.
Her announcement came as lawmakers questioned whether Accutane causes suicidal depression in teen-agers -- a charge made Tuesday by one teen who attempted suicide.