Accutane Timeline

1982—Hoffman-La Roche wins Food and Drug Administration approval for Accutane as treatment of severe acne.

June 1985—Accutane’s package insert amended to list side effects associated with the medication, such as seizures and emotional instability including depression, dizziness, nervousness, malaise, weakness and insomnia.

1988—Public Citizen’s Health Research Group seeks ban on sale of Accutane.

1988—Godfrey Oakley of Centers for Disease Control and Prevention attributes the deaths of 40 infants to Accutane exposure from their mothers; he urges removal of drug from market.

1990—FDA scientist David Graham, too, urges withdrawal of Accutane because of birth defects and result of abortions by women unwilling to have children with deformities. In memo, he writes, “The magnitude of injury and death has been great and permanent, with 11,000 to 13,000 Accutane-related abortions and 900 to 1,100 Accutane-related birth defects.”

1992–1994—French study links Accutane with depression. Authorities there add suicide to list of possible side effects.

August 1997—FDA rebukes Roche for failing to submit serious adverse event reports in timely manner. Roche blames its computer systems for eight-year delay.

February 1998—FDA mandates warning on Accutane packaging that users may experience depression, psychosis, suicidal ideation, suicide attempts and suicide.

December 1999—Roche issues paper to FDA denying responsibility for 168 cases of suicide linked to Accutane.

May 2000—Roche updates Accutane’s warning label to include possible side effects involving depression, suicidal thoughts, suicide attempts and suicide.

October 2001—FDA compels Roche to more fully inform doctors and female patients about dangers of Accutane.

June 20, 2002—FDA official tells House subcommittee about reports of 3,104 adverse psychiatric events and 173 suicides involving Accutane.

August 15, 2005—FDA introduces iPLEDGE  program. Women who wish to take Accutane must agree to scrupulously avoid pregnancy while using the drug.

August 2006—Studies published in Archives of Dermatology and American Journal of Gastroenterology show that Accutane can raise cholesterol, triglycerides and liver enzyme levels, and cause irritable bowel syndrome.

September 2006—Study by scientists at the University of Texas and University of Bath (results published in Neuropsychopharmacology) establishes conclusive link between Accutane and depression.

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