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Accutane Linked to Birth Defects, Should Be Pulled From Market, Public Citizen Tells FDA

Feb. 26, 2004

Accutane Linked to Birth Defects, Should Be Pulled From Market, Public Citizen Tells FDA

WASHINGTON, D.C. – The acne drug Accutane, which causes birth defects and life-threatening adverse events, should be removed from the market and prescribed only under very limited and controlled conditions, Public Citizen told a government panel today.

At a meeting of a U.S. Food and Drug Administration (FDA) advisory committee, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, described how the drug causes such birth defects as malformations of the heart and brain, and can cause depression and create pressure in the brain in patients taking it. About 25 percent of the babies born to mothers taking the drug have serious birth defects and 50 percent are mentally disabled. Many women who become pregnant while taking the drug have abortions because of this high birth defect rate.

Accutane is approved only to treat severe cystic acne but is prescribed to many people who have mild acne. In fact, it is prescribed to 26 times more women than it should be, Wolfe estimates.

A program launched in April 2002 by the FDA and Accutane’s manufacturer, Roche, was designed to reduce the number of pregnant women taking the drug, but it has not worked, Wolfe said. In the program’s first year, 48 of 61 reported pregnancies (79 percent) ended in elective abortions because of concerns about the high rate of birth defects caused by the drug. Applied to the estimated number of total pregnancies in women taking Accutane during that year, an estimated 431 women had abortions because of the drug’s high defect rate, 16 infants were born with birth defects and 31 babies were born with mental retardation. From 1982 to 2000, 162 babies were reported born with birth defects attributable to Accutane.

“If the government doesn’t act, this administration and advisory committee will continue to put its imprimatur on the reckless use of a drug that each year causes the need for hundreds of abortions and results in many seriously deformed infants with birth defects,” Wolfe said. “This is one of the two worst epidemics of preventable serious birth defects ever seen in the United States. It is time to end it.”

Officials have known for at least 20 years of the dangers associated with the drug. In 1983, Public Citizen petitioned the FDA to give patients warning information with the drug. In 1988, Public Citizen petitioned for a ban on Accutane, but the agency didn’t act. Public Citizen will petition the agency again soon for the drug’s withdrawal, Wolfe said. Wolfe told officials today that the drug should be prescribed only if photographic proof exists of severe cystic acne and the patient has not responded to other acne treatments. In addition, for women, a written statement should detail the patient’s contraceptive practices and the patient should have a negative pregnancy test.

Click here to view Wolfe’s presentation.