Accutane is a prescription medication chemically similar to Vitamin A, which is used to treat serious forms of cystic acne. Accutane has been manufactured in the United States by a division of Hoffmann-La Roche, Inc. since 1982.
Controversy over Accutane focuses primarily on two areas of potential harm: The use of Accutane by pregnant women is associated with certain birth defects, and its use by teenagers is associated with depression and possibly with suicidal behavior.
Fetal risks have long been known to the manufacturer, and it initiated an educational program to reinforce to female patients the importance of pregnancy prevention. It also includes a graphic insert in its packaging, warning of potential birth defects.
Due to continuing concerns over the number of women who become pregnant while taking Accutane, in 2002 additional safety protocols were initiated, including the requirement that women receiving Accutane twice test negative for pregnancy, and sign a commitment to use two forms of birth control while continuing treatment with Accutane.
In August 2005 the FDA strengthened safety warnings and added a requirement that women receiving Accutane and doctors prescribing it participate in a national database.
In 1998 the FDA sent doctors a notice indicating that Accutane might be associated with increased levels of depression. After two high-profile suicides by teenaged Accutane users, the manufacturer was inspired to add additional warnings about depression as a possible side-effect of Accutane use, but asserts that there are no mental health problems associated with its product.
Some product liability lawyers continued to assert that the association is very real, and that Accutane's warnings were inadequate to protect users from its dangers. Accutane remains on the market.