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Tighter Accutane restrictions announced by FDA

-November 23, 2004

The FDA announced today a national registry for women of childbearing age prescribed the drug Accutane has been set up. Accutane is a powerful acne medication that can cause serious birth defects, including brain and heart damage, even in small amounts. Ever since Accutane was introduced to the market in 1982, Accutane has been controversial.

More than 2,000 reports of women becoming pregnant while taking Accutane have been made since the drug emerged. The majority of women had an abortion, but more than 160 babies were born with Accutane-related birth defects. The FDA offered a voluntary testing and contraceptive education program in 2001 for patients considering Accutane, which many criticized as being ineffective. Accutane was under even more scrutiny after FDA safety reviewer Dr. David Graham singled out five drugs on the market that presented serious health dangers and Accutane was one of them.

Graham was presenting testimony before the Senate Finance Committee regarding the Vioxx recall that was announced at the close of September. In February, an expert advisory panel said the FDA should track women who could become pregnant while taking Accutane. Following the Vioxx recall, the FDA was under even more criticism for its inability, according to many critics, to adequately protect consumers from dangerous drugs after receiving approval. When Graham said Accutane was dangerous and should be "seriously looked at," the federal agency finally acted.

Under the Accutane changes, women must document a negative pregnancy test before they are able to get the drug. In a statement, the FDA said the national registry would track each woman's name, prescribing doctor and pharmacy dispensing the medication. Patient and physician codes will be incorporated into the registration system in order to protect the privacy of both, the FDA said.

For more information on Accutane, please contact us.

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