U.S. panel to review restrictions on Roche's Accutane

02/26/2004 | Reuters

The FDA will ask an outside panel of experts if tougher restrictions are needed on the use of Accutane, a highly effective prescription drug against acne but one that also can cause birth defects. The panel will review new data showing efforts to keep pregnant women from taking the drug with strongly worded warnings and controls have fallen short. A Roche spokeswoman said the drug maker has proposed new restrictions and will consider the advice of the panel.

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