The Nation - News from April 24, 1988

The manufacturer of a popular drug used to fight acne has denounced a study that concluded that the medicine may have caused severe deformities and other birth defects in hundreds of babies. Hoffman-La Roche Inc. of Nutley, N.J., manufacturers of Accutane, denounced the study by the U.S. Food and Drug Administration as a “grossly defective statistical extrapolation” because of the small data base involved. A Hoffman-La Roche spokesman said that anyone familiar with the company’s intensive efforts to educate doctors and patients about the potential side effects of Accutane would conclude “that the company has been nothing but highly responsible.” An advisory panel of leading dermatologists from around the country is scheduled to meet Tuesday at FDA headquarters in Rockville, Md., to consider options for ensuring that pregnant women do not continue taking Accutane.