Firms Won’t Claim Aspirin Prevents First Heart Attacks

The nation’s major aspirin manufacturers, yielding to pressure from federal regulators, agreed Wednesday to refrain from promoting the regular use of aspirin to prevent first heart attacks.

One month after a major study indicated that an aspirin every other day reduces the risk of primary heart attacks, the Food and Drug Administration warned industry officials in a closed meeting Wednesday that such advertisements might be injurious to public health and a violation of federal law.

“There is a tendency when a study comes out . . . for people to try to change their behavior on a single study,” said Dr. Frank E. Young, commissioner of the FDA. “That is dangerous.”

Cites Cerebral Bleeding

Emphasizing that the study results were preliminary, Young said that improper use of aspirin could lead to cerebral bleeding, hemorrhagic stroke and other complications.

“In some segments of the population, a regimen of aspirin year in, year out, could be more risky than beneficial,” according to a statement issued by the FDA. “These might include men with uncontrolled or unsuspected high blood pressure or any tendency to bleed excessively, young men with no history or other risk factors for cardiovascular disease and premenopausal women.”

Several industry officials said that they have not yet promoted aspirin for use in reducing the risk of first heart attacks, although they have launched campaigns advertising the benefits of the drug in preventing second heart attacks.

“We are in total agreement with the commissioner and his guidelines not to promote aspirin to prevent first heart attacks,” said a spokesman for Sterling Drug Inc., the manufacturer of Bayer aspirin. “We have not promoted that indication and had not planned to until it was approved as an indication by the FDA.”

Findings Termed Dramatic

In January, the preliminary results of a major study published in the New England Journal of Medicine said that an aspirin every other day may be highly effective in preventing the onset of first heart attacks. Researchers said the findings were so dramatic that they had prematurely ended the long-term study so that all 22,071 participants, half of whom did not take aspirin, could benefit from the newly gained information.

In the 57-month study, whose participants were all male physicians, 104 of the 11,034 who took aspirin suffered heart attacks, while there were 189 heart attacks among the 11,037 who were given placebos, or sugar pills. Statistically, that translated into a reduction in risk for the healthy men of up to 47%.

Young emphasized that the study group did not include those with liver or renal disease, gout or peptic ulcers, all of whom would also be at risk from the increased use of aspirin.

Further, he said in a statement that “the benefits of aspirin do not appear to be nearly as dramatic as, say, quitting smoking and should not be used as a substitute for reducing excess weight, reducing excess cholesterol levels, or reducing high blood pressure.”

Young refused to say whether any aspirin advertisements already shown had violated federal law by making exaggerated claims or were under investigation by the government.

Officials from the Federal Trade Commission, which regulates nonprescription drug advertising, were also present at the meeting.

In a letter to aspirin manufacturers Feb. 24, and in Wednesday’s meeting, Young said that the FDA staff members had met with Dr. Charles H. Hennekens, the study’s principal investigator, to review the preliminary data. Young said that Hennekens “expressed concern that widespread use of aspirin without careful patient selection by physicians could do more harm than good.”

Full Evaluation Needed

Young called the study “well-designed” and “well-conducted” but said that the full report must be completed and evaluated by the FDA before aspirin can be labeled to reflect “both the potential risks and the potential benefits” associated with use “in various subgroups of the population.”

Young said: “This morning I reminded aspirin manufacturers that, until we have had a final report on this study and some careful analysis, physicians will not have clear guidelines regarding which of their patients might benefit from an aspirin every other day--and which of their patients might be harmed.”

He said that the FDA’s review would be completed “expeditiously” and then “we would be ready to change the ‘physician’s labeling’ . . . to include information on aspirin’s use to prevent primary heart attacks.”

He added: “The same process was followed in 1985 . . . on the use of aspirin to prevent second, as opposed to initial, heart attacks.”