FDA Tightens Restrictions on Accutane

Approves registry to protect women of childbearing age

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TUESDAY, Nov. 23, 2004 (HealthDayNews) -- The U.S. Food and Drug Administration announced Tuesday that it has set up a national registry to follow women of childbearing age who are prescribed the acne drug Accutane, which has been shown to cause serious birth defects.

The agency followed the suggestions of an expert advisory panel, which in February said the agency should track women who could become pregnant while taking the drug. Accutane, generically known as isotretinoin, is known to cause brain and heart damage in the fetuses of women who use the drug, even in small amounts.

The move comes amid allegations by some critics that the agency hasn't worked hard enough to protect the public against the harms caused by some drugs, including Accutane, after they have been approved.

Under changes to the drug's tougher risk minimization plan, women must document a negative pregnancy test before they are able to obtain the drug. The national registry will track each woman's name, prescribing doctor, and pharmacy that dispensed the medication, the FDA said in a statement.

The registration system will incorporate patient and physician codes that will protect the privacy of both, the agency said.

Last week, Accutane was singled out by FDA safety reviewer Dr. David Graham as one of five drugs still on the market that posed health dangers like Vioxx, the now-withdrawn arthritis medication. Graham was an early critic of Vioxx, which was withdrawn by Merck & Co in September after the company's own research cited an increased risk of heart attack and stroke.

In testimony on Nov. 18 before the Senate Finance Committee, Graham said Accutane was similarly dangerous and should be "seriously looked at."

The FDA's new Accutane rules include provisions for providing ongoing patient education about the drug's potential risks. Accutane has been shown to cause mental retardation and physical birth defects, including cleft lip and palate. The risks continue for about a month after a patient discontinues the drug.

Since 1982, when the drug was first introduced, the FDA has had more than 2,000 reports of women becoming pregnant while taking the drug. Most had an abortion, some gave birth to healthy babies, but more than 160 babies were born with Accutane-related defects.

The FDA instituted a voluntary testing and contraceptive education program in 2001 for patients considering the drug.

More information

Get a Q&A on the latest Accutane move from the U.S. Food and Drug Administration.

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