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DANGERS OF ACCUTANE EMPHASIZED

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Medical experts say stronger efforts are needed to make sure women do not use the acne drug Accutane during pregnancy because it can cause birth defects.

The drug that offers hope to people suffering from a severe, disfiguring form of acne also can cause serious birth defects in one out of four cases where the mother used Accutane during pregnancy, officials say.Experts on two committees advising the Food and Drug Administration agreed Monday that the manufacturer, Hoffman-LaRoche, has alerted physicians and patients to the birth defect risk. But the committees recommended that more be done to get the word out.

Hoffman-LaRoche officials said they were pleased with the recommendations, two of which were similar to additional warnings the company had announced earlier in the day.

The FDA advisory committees rejected the advice of some within the agency who want Accutane withheld from all women to eliminate any risk of birth defects from the drug.

The committee actions came as other physicians were reporting that Accutane can significantly block the growth of new tumors in people being treated for smoking-related cancer of the mouth and throat.

Accutane has been on the market since 1982 to treat what is called severe recalcitrant cystic acne.

In September 1988, Roche Dermatologics, a division of Hoffman-LaRoche, began a program aimed at educating physicians about the importance of having patients avoid pregnancy during Accutane treatment.

Roche officials say 86 cases of birth defects have been reported to the company as being associated with Accutane since the drug was first marketed.

But David Graham, an FDA medical epidemiologist, said that number represents only about 10 percent of the number that actually occur. He estimated that since 1982, nearly 1,000 babies have been born with birth defects associated with Accutane.

Graham also estimated that 90 percent of the women using Accutane do not have the severe form of acne for which the drug is intended. They could be treated with other drugs without the kind of risk Accutane poses, he said.

Accutane was prescribed last year for about 65,000 women of childbearing age. Graham said less than 4,000 women are estimated to have the severe form of acne that requires Accutane treatment.

The overprescribing exposes tens of thousands of women to the possibility of a malformed child if they become pregnant while being treated, he said.