Accutane Overview
Accutane is a prescription drug used to treat serious forms of cystic acne, one of the most common forms of skin disease. 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, Accutane is the brand name for the generic drug isotretinoin. While there are clear benefits to the use of Accutane, for decades the drug has been known to cause birth defects when used by pregnant women. In addition, a number of recent lawsuits have claimed a link between the acne drug and depressive or suicidal behavior.
Side Effects - Birth Defects
Even before Accutane was approved by the FDA, studies showed that it could cause birth defects in animals. It was designated as "Category X," meaning that it must be avoided by women under all circumstances during their pregnancy. On its label, Roche warned against use of Accutane by pregnant women, but pregnancies resulting in birth defects caused by Accutane still occurred. So in 1988, the company instituted a voluntary program designed to prevent pregnancies during Accutane treatment, called the Accutane Pregnancy Prevention Program (PPP).
Roche sent PPP kits to physicians, and encouraged them to review them with patients before prescribing Accutane. Materials in the kit included a booklet about contraception, and consent forms for patients to sign, acknowledging their understanding of the risk of birth defects associated with Accutane use. Roche also sponsored a survey to assess compliance with the program. To further reinforce pregnancy prevention, Roche began packaging Accutane in blister packs that included warnings set in red and black, a drawing of a malformed baby, and an "Avoid Pregnancy" symbol. Roche also set up a toll-free telephone line, made contraceptive information available in 13 languages, and offered to pay for contraceptive counseling and pregnancy testing performed by a specialist. Still, a 1999 survey showed that of 500,000 women who took Accutane from 1989 to 1998, about 3 in 1,000 became pregnant. As a result, the FDA required Roche to undertake more labeling changes.
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