Acne drug Accutane use restricted by FDA

When Dr. David Graham, the world-renowned scientist a the FDA, included Accutane in the same list as GlaxoSmithKline's asthma drug, Serevent, AstraZeneca's cholesterol fighter Crestor, Pfizer's arthritis treatment Bextra, and Abbott Laboratories weight-loss drug Meridia, everybody expected that within a matter of months all of these drugs will be recalled. Dr. Graham was responding to the recall of Vioxx by Merck and news that as many as 140,000 injuries may have been caused by Vioxx, including upto 60,000 deaths.

Here is an update. None of these drugs, except Bextra, have been recalled. In the case of Crestor, Meridia, and Serevent, the FDA has essentially taken the same irresponsible approach for which it is now notorious - favoring the industry over American people. In an annoucement that appears very similar to its previous decisions, the FDA again has refused to force a recall of Accutane. Instead, it is developing a highly complex program that can be very confusing and cumbersome to consumers. Plus, even a small mistake in its administration will have disastrous results.

The manufacturers of Accutane and its generics (Isotretinoin) are implementing a program that requires registration (iPLEDGE by) doctors and patients who agree to accept specific responsibilities before receiving authorization to prescribe or use the drug.

Accutane is believed to be a highly effective drug for severe recalcitrant nodular acne, but it carries a significant risk of birth defects if taken during pregnancy. The other brand names under which the drug is sold are Amnesteem, Sotret, and Claravis.

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