Accutane
Background Information
Accutane/Roaccutane (Isotretinoin)
Manufacturer: Hoffman-Roche, a Swiss Co.
Roche in U.S., Nutley N.J.
Roche submitted its "new" drug application in July 1981 and the FDA approved it less than a year later on May 21, 1982.
1982-1988 - Thousands of women were warned only that the drug caused birth defects in animals, and no precautions were taken. "Between 1982-1988, more than 1000 babies were born missing ears, major organs and portions of the brain. Others were stillborn. Still others were aborted."
March 3, 1997 - France - French studies showed users of Accutane/Roaccutane suffered from severe depression and suicidal ideation. French equivalent of FDA ordered warning to consumers.
Accutane is Hoffman-Roche's second-largest-selling drug, bringing in $800 million in sales in 1998.
