Skip to content

    Acne Health Center

    Font Size
    A
    A
    A

    Lawmakers Point to Psychiatric Risks of Acne Drug


    WebMD Health News

    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.

    Today on WebMD

    Girl with acne
    See if you know how to control your acne.
    happy woman with clear skin
    Triggers and treatments for blackheads, whiteheads, and cystic acne.
     
    Bride with acne
    Dos and don’ts for hiding breakouts.
    close-up of a young man soaping his face
    Why adults get acne and how to treat it.
     
    Doctors
    Article
    Boy cleaning acne face
    Quiz
     
    HPV Vaccine Future
    Video
    beauty cream
    Article
     
    Bride with acne
    Slideshow
    Woman applying mineral makeup
    Slideshow
     
    69x75_mineral_makeup.jpg
    Video
    Arrows pointing on teen girl blemish
    Quiz
     

    WebMD Special Sections