Accutane (generic name: isotretinoin) is a prescription drug intended to treat severe, recalcitrant, nodular acne. The side effects of Accutane include inflammatory bowel disease, rectal bleeding, Crohn's disease, ulcerative colitis, proctitis, enterocolitis, ileocolitis, ileitis, sigmoiditis, colitis, premature epiphyseal closure, desiccation of the spine and discs, optic neuritis, cirrhoses, hepatotoxicity, and severe birth defects.

Accutane is used to treat serious forms of cystic acne, one of the most common forms of skin disease. It is manufactured in the U.S. by a division of Hoffmann-La Roche, Inc., and approved by the U.S. Food and Drug Administration in 1982. Even before the FDA approved Accutane, studies showed that it could cause birth defects in animals.

Additionally, in 1998, the FDA advised doctors who prescribe Accutane to watch their patients for signs of depression. Thereafter, Hoffman-La Roche notified doctors that the drug ”may cause depression, psychosis, and, rarely, suicidal ideation, suicide attempts and suicide.''

Despite all this, the knowledge of Accutane's potentially dangerous side effects did not become widely known until May 2000, when a Congressman's son committed suicide. Rep. Bart Stupak says his 17-year-old son's suicide may be linked to the popular acne medicine. Bart Stupak Jr. shot himself in the head with his father's gun in the early hours of May 14. He was popular in school, a football player, and killed himself after a prom-night party.

Rep. Stupak stated "We are up over 100 reports, that's just what is coming in to us, so I believe there are probably over a thousand cases. The average time is 88 days from when you start taking it, and the effect is very sudden.... You are doing strange things at 3 a.m. and you are dead at 7 a.m."

According to USA Today , as of December 2000, the FDA had received reports of 66 suicides and 1,373 cases of psychiatric problems among Accutane users. Accutane's package warning first stated a potential relationship between Accutane and depression in 1986. Although French officials required that Hoffman-La Roche add the risk of suicide to the package insert of the European version of Accutane in March 1997, the FDA did not require such a change in the USA until 1999.