Lawmakers Point to Psychiatric Risks of Acne Drug
WebMD News Archive
Oct. 5, 2000 (Washington) -- The acne drug Accutane needs tighter safety controls because it may trigger depression and suicide, federal lawmakers said Thursday.
Rep. Bart Stupak (D, Mich.) said that the drug's maker, Roche, should pay for independent studies of the medication's psychiatric side effects and called for additional FDA funds for surveillance of the drug. In May of this year, the congressman's son, B.J., committed suicide while on Accutane.
Stupak also said everyone taking the drug should sign an informed-consent form that clearly warns of these risks, and that Roche should refrain from direct-to-consumer advertisements until the research is completed.
"The company can do it starting today," said Rep. Thomas Barrett (D, Wis.). "I hope that [Roche] will show some civic responsibility." The lawmakers' press conference Thursday had a grim emotional intensity, with surviving members of Stupak's family in attendance, along with several couples who lost teen-agers to suicide while they were on Accutane.
The drug, available since 1982, is supposed to be used only to treat some types of severe acne that have not responded to other therapies. Accutane has long been forbidden for use in pregnant women, since it has caused severe birth defects.
Roche representatives could not be reached for comment Thursday. But in a presentation last month to an FDA advisory committee, company representatives said that "spontaneous" adverse psychiatric events such as suicide reflect "the multiple risk factors in the adolescent and young adults afflicted with the disfiguring disease of acne." Not only does suicide stem from many factors, the company said, but adolescence itself is a risk factor for suicide, and acne contributes to psychological distress.
The FDA says the drug has been associated with 44 suicides since 1983. But Stupak says his office's own analysis indicates that "in the last two-and-a-half years, there have been almost two suicides a month associated with the use of Accutane."
Roche sent a letter to doctors two-and-a-half years ago, alerting them to a new prescribing warning that states: "Accutane may cause depression, psychosis, and rarely, suicidal ideation, suicide attempts and suicide." But according to Stupak, only this year did the company make this change to the drug's actual product labeling.
"There is evidence pointing to an association with depression," says an FDA spokeswoman, who spoke to WebMD on condition that her name not be used. "But there is not enough data to make a causal link between Accutane and psychiatric conditions."
In a session on Accutane last month, an FDA advisory committee recommended that the drug be distributed with "MedGuides" -- patient tools that the agency is developing to describe in plain terms the risks of certain medications. The agency also says it plans to require expanded use of consent forms with the drug; they're now used only for women.