Accutane is a powerful prescription drug that can cure cystic acne, a severely disfig-
uring skin disorder. But if pregnant women take the capsules, U.S. Food and Drug Administration researchers say that the vitamin-A derivative can cause facial deformities and stunt brain and heart development in un-
born children. In 1982 the FDA approved the sale of Accutane only on the condition that its manufacturer, Switzerlandbased Hoffmann-La Roche Inc., insert strongly worded warnings in Accutane packages. Those inserts caution women not to take the drug during pregnancy. Declared Dr. Norman Levine, chief of dermatology at the University of Arizona medical school in Tucson: “We have to decide whether we want to be spared a relatively few potentially disastrous birth defects or go for the greatest good for the greatest number.”
But in April FDA researchers estimated that as many as 1,300 U.S. babies with severe birth defects could have been born to Accutane users since 1982. They projected those national figures by extrapolating the results of a Michigan study that involved about 1,000 women.
And in Ottawa, federal health officials report that since Accutane became available in Canada in 1983, at least three newborns—and three fetuses— exhibited gross malforma-
tions. For its part, the company disputes the U.S. projections, arguing that there have been 71 confirmed cases of birth defects worldwide that were caused by the drug. Those defects include mental retardation, abnormally small jaws, and ears growing below the chin.
FDA researchers later revised their projections and now estimate that 597 birth defects have been caused by Accutane. But some Canadian and U.S. physicians still want to ban Accutane, a drug that is generically known as isotretinoin. Indeed, Dr. Godfrey Oakley, the director of the division of birth defects and developmental disabilities at the Centres for Disease Control in Atlanta, has compared the adverse effects of the drug to those produced by thalidomide. It is a sedative that was widely prescribed to pregnant women in the 1960s, causing about 6,000 babies to suffer such defects as missing
limbs and flipper-like arms and feet. Declared Oakley: “We want to make the point that this drug is as bad as thalidomide.”
Officials at Hoffmann-La Roche— the company sold $6 million worth of Accutane in 1987 alone—acknowledge that the drug can be hazardous if women do not heed the printed warnings in the packages. Said company spokesman Carolyn Glynn: “So far, pregnancy risk does seem to come with this class of drugs.”
In response to public alarm following the release of the FDA report, dermatological experts conducted reviews weighing the risks and benefits of Accutane and reported their findings to the U.S. and Canadian governments. But late last month Dr. Agnes Klein, chief of the dermatological division of Health and Welfare Canada, said that Ottawa would not take the drug off the market. Declared Klein: “It is a neces-
a necessary drug even though it is known to cause malformations. Its usefulness warrants taking extra precautions. You cannot deny people something that is good for them.” Added the University of Arizona’s Levine: “For those who would end up with a face full of scars, this drug is a godsend.”
Klein and her committee of dermatology experts drafted several recommendations regarding the use of Accutane. One of those provisions that the federal government is now studying would require physicians to conduct pregnancy tests on women before prescribing the drug. Similarly, members of a U.S. medical advisory committee have also recommended stiffer controls to the FDA. They urged, among other measures, that the distribution of Accutane be transferred from pharmacists to a limited number of physicians certified to handle the drug. Declared Dr. Harold Minus, a committee member and associate professor of dermatology at Howard University school of medicine in Washington: “Pharmacists
are not going to sit down and tell a patient what they need to know. We need one-on-one discussions between patients and physicians.”
FDA spokesmen said that the agency would take action on the recommendations before the end of June. But those measures will come too late for hundreds of mothers. For them and their deformed children, a drug that promises relief for many victims of severe acne has brought only pain and suffering.
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