FDA warns aspirin makers.

FDA warns aspirin makers

Stressing the preliminary nature of a recent study showing aspirin's prevention of first heart attacks. Food and Drug Administration (FDA) Commissioner Frank E. Young told aspirin manufacturers last week that advertisements making such claims would be considered "mislabeling" and could lead to federal regulatory action. Young met with manufacturers at FDA's headquarters in Rockville, Md., to discuss industry's response to two studies released in January. The U.S. study found a marked decrease in the incidence of first heart attacks among men taking aspirin every other day (SN: 1/30/88, p.68). A smaller study by British scientists, however, failed to find any benefits (SN: 2/6/88, p.84). Young warned the industry representatives that the FDA will not make a final decision on the appropriate guidelines to physicians until further studies are done and questions answered about an increase in strokes among test subjects taking aspirin. In a prepared statement, Young said the manufacturers "agreed to exercise voluntary restraint and refrain from further promotion of the study results" pending the final results.