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Accutane is one of the five drugs that Dr. David Graham warned Congress about last week. It is one of the few drugs that has an X classification, which means it is guaranteed to cause birth defects in a pregnant woman. Earlier this week the FDA announced that plans to strengthen its efforts to prevent pregnant women from taking the drug, which can cause serious fetal abnormalities. The FDA called the announcement a coincidence but if you believe that one I am concerned that you might be missing the picture here.
The FDA said that the new plan, expected to go into effect next July, borrows from a successful program developed to prevent pregnant women from taking thalidomide which caused serious birth defects in thousands of babies in the late 1950s and early 1960s. Thalidomide wasn't sold in the USA until 1998, when the FDA approved it to treat leprosy.
Under the new Accutane plan, doctors who prescribe the drug, pharmacists who dispense it and patients who take it will have to register with a central clearinghouse. This applies to Accutane, which is the brand name for isotretinoin, as well as generic versions on the market. Any patient who could get pregnant must present a negative pregnancy test before getting a prescription filled.
I am glad the FDA is tightening up the rules for prescribing Accutane, but the reality is that this drug doesn't even need to be prescribed at all as there are far safer acne options available.
USA Today November 25, 2004