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GAITHERSBURG, MD - The Food and Drug Administration (FDA) has suggested that they are in favor of strong controls on the acne drug Accutane, which can cause severe birth defects when taken by pregnant women. Babies born to women using Accutane while pregnant have a 20% to 25% chance of having severe abnormalities in their brains, hearts, and other organs. During the first of two meetings, the FDA presented plans to prevent pregnant women from using the drug.
The first initiative calls for doctors and patients to register in order to gain access to the drug. Physicians would perform pregnancy tests before prescribing it, and the patient would have to report any contraceptives she was using. A pharmacist would also have to confirm that there was a negative pregnancy test before dispensing the prescription. The second scenario would add to these restrictions a requirement that pharmacies supplying the drug be specially trained, registered, and authorized.
The FDA approved Accutane in 1982. Since then, 1,995 pregnancies have been reported by women on the medication. 70% of these pregnancies occurred after the drug's manufacturer, Hoffmann-La Roche Inc., Nutley, NJ, put in place an extensive pregnancy-prevention program, that included repeated warnings and recommendations for pregnancy test prior to prescribing the drug. For more information visit www.wsj.com.