A U.S. advisory panel on Monday voted 11-3 against a Bayer Corp. proposal to approve broader use of aspirin to protect the hearts of patients who have not had a heart attack.
Now, daily therapy with low-dose aspirin is cleared for preventing heart attacks in patients who already have had an attack, which puts them at high risk for another.
Many members of the Food and Drug Administration panel said they believed aspirin also would benefit other people at risk for a heart attack. But a majority said available data did not provide strong evidence that benefits outweighed side-effect risks for the patients Bayer targeted.
"There is a paucity of data ... in the setting in which we are being asked to make a judgment, said Thomas Fleming, chair of biostatistics at the University of Washington.
The FDA will consider the recommendation. The agency usually follows the advice of its panels.
Aspirin can stop blood from clotting and causing a heart attack, but it also can cause potentially fatal stomach bleeding and strokes in a small percentage of patients.
Bayer, which developed aspirin more than 100 years ago, wants the FDA to approve an updated label for physicians to reflect American Heart Association guidelines, which recommend aspirin for people who have not had a heart attack but face at least a 10 percent risk of having one over 10 years.
Doctors can pinpoint those patients, considered at moderate risk, by assessing blood pressure, cholesterol, family medical history and other factors, Bayer said.
Based on studies of more than 55,000 people, Bayer estimated five years of daily aspirin use by that group could prevent 14 heart attacks for every 1,000 patients treated. Up to two strokes and two to four cases of major gastrointestinal bleeding also would be expected, the company said.
If the agency approved the new label, Bayer could promote the broader use. Bayer argued that the change would help get the message about aspirin’s benefits to doctors and patients.
“We believe there is a major public health benefit to be had,” Dr. Thomas Pearson, a Bayer consultant from the University of Rochester, told the panel.
Bayer will continue discussions with the FDA about a broader aspirin approval, said Erica Peitler, a senior vice president for the company.
A broader label would not be expected to contribute significantly to the company’s earnings, Bankgesellschaft Berlin analyst Meng Si said before the panel meeting.