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FDA Imposes Stronger Rules for Accutane for Treating Severe Acne

Source: U.S. Food and Drug Administration

The Food and Drug Administration announced strengthen new regulations Friday for the acne drug Accutane-aimed at preventing use of the drug during pregnancy. Women who are pregnant or who might become pregnant should not take the drug, the Agency said.

Accutane (and its generics) is a highly effective drug for severe recalcitrant nodular acne, but it carries a significant risk of birth defects if taken during pregnancy.

The regulations require doctors and patients who agree to accept specific responsibilities before receiving authorization to prescribe or use Accutane. The FDA said these measures are designed to guard against pregnancies while using Accutane. Wholesalers and pharmacies must also comply with the manufacturers' program requirements in order to distribute and dispense the product.

"This stronger program is a major step in protecting against inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin," Dr. Steven Galson, Director, FDA's Center for Evaluation and Research, said.

In February 2004, at a joint meeting, FDA's Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee reviewed the existing Accutane risk management programs in effect at that time. Based upon their review, the joint committee called for major improvements in the restricted distribution program, including mandatory registration to ensure that patients who could become pregnant have negative pregnancy testing and birth control counseling before receiving the drug.

Read Full Story at U.S. Food and Drug Administration

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