Early Warnings

Since it came onto the market nearly six years ago, the acne drug Accutane has carried stark warnings that it causes birth defects: pregnant women must not take it, and other women must use birth control while on it. The warnings, it seems, have not been enough. Some researchers at the Food and Drug Administration fear that the widely used drug could have caused between 900 and 1,300 babies to be born with severe birth defects, including brain damage. The FDA's concerns became public last week after the New York Times obtained a confidential agency report that raised the possibility of taking Accutane off the market.

The drug is prescribed for patients with severe acne who have tried other medications without success. It is highly effective, and half the million people who have taken it are women. There is no doubt that Accutane can cause birth defects, says its manufacturer, Roche Laboratories of Nutley, N.J. But Roche has received reports of only 61 malformed infants born to women who have taken the drug, and the company sharply disputes the figures in the FDA memo. Says Roche Spokeswoman Carolyn Glynn: "The data are grossly exaggerated." An FDA representative acknowledges that Roche's tally is correct and that the 900 to 1,300 figures are projections, not official figures. The internal report containing them was originally meant to be discussed this week, when FDA and Roche officials will meet to consider Accutane's fate.