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Tighter rules on acne drug recommended


GAITHERSBURG, Md. - An advisory panel recommended yesterday that the Food and Drug Administration further tighten restrictions on the acne drug Accutane, which is known to cause severe birth defects.

The panel recommended, on a 16-8 vote, mandatory enrollment in a single central registry for patients who take the drug and doctors who prescribe it. The registry would allow the drug's makers to ensure that women taking Accutane or a generic equivalent, isotretinoin, receive regular pregnancy tests and use two forms of birth control.

At present, two registries are kept; enrollment is voluntary.

The panel's recommendation came almost two years after Hoffmann-La Roche, Accutane's manufacturer, and three makers of generic forms of the drug imposed tougher restrictions on how it is prescribed, in an attempt to prevent pregnant women from taking it.

Critics said that such voluntary measures have failed. The FDA agreed and asked the advisory panel to suggest new protections.

In 2003, seven pregnant women were given Accutane, and two gave birth to infants with birth defects related to the drug, the FDA said. Among 120 women who became pregnant after they started taking Accutane or a generic, 48 elected to have abortions and six had miscarriages.

The figures were similar to those in 2002, despite the new restrictions, the FDA said, adding that the actual number of pregnancies is probably even higher.

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