Tight FDA controls on isotretinoin (Accutane) prescribing have failed to in women on the acne drug. Isotretinoin, a vitamin A derivative, carries a 35% risk of severe birth defects. The drug is indicated for severe cystic acne, but is commonly prescribed for mild cases.
A year ago, concerned by the high number of women becoming pregnant while taking isotretinoin, the FDA required patients, physicians and pharmacists to enrol in its iPledge program. This includes receiving and understanding detailed information about the drug and its side effects and, for premenopausal women, taking birth control and passing pregnancy tests before each refill. After a year, the number of pregnancies remained constant at about 120.
The FDA data doesn't know why the pregnancies occurred. Although all childbearing-age women were supposed to be using two forms of birth control, only 90% of the pregnant women were. Seventy-two percent say they were on the pill and using male condoms; an astonishing 18% cited "abstinence" as their birth control method. The remaining 10% aren't accounted for, although the FDA reported that two women, who were pregnant when they started on the drug, had prescribers falsify their pregnancy tests to get access to Accutane.
So are these pregnancies the result of bad luck, carelessness, stupidity or deceit? It's most likely a combination.
Another culprit is overprescibing of this strong med. Although it's only indicated for "severe recalcitrant nodular acne," which affects a tiny proportion of the population, it's commonly prescribed for normal acne. "[I]t's estimated that in the U.S., 90% of prescriptions are off label," Lynn Martinez, Utah State Health Department coordinator of the Pregnancy Riskline in Salt Lake City .
The same article points out that isotretinoin is far worse than thalidomide, carrying a 35% chance of birth defects versus 20% with thalidomide. However, many dermatologists consider isotretinoin something of a wonder drug and oppose tighter restrictions or its removal from the market. "[iPledge] is one of the worst things that's happened to our specialty. We're taking a very good drug that is for many people the only real choice out of reasonable access," Boston dermatologist Dr Ranella Hirsch . In fact, an FDA advisory committee recommended on August 1 that prescribing restrictions be relaxed slightly.
In Canada, isotretinoin carries an additional warning about , but there is no equivalent safety program to the FDA's iPledge. Health Canada reports a total of three fetal disorders possibly caused by Accutane from January 1983 to December 2004, but the Motherisk program at Toronto's Hospital for Sick Children says .
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