FDA nixes use of aspirin for primary prevention

Share this article:

FDA issued a statement regarding aspirin's use in preventing heart attacks, saying it does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke.

It comes after the agency denied a request from Bayer HealthCare, requesting a change in the prescribing information for HCPs (professional labeling) for aspirin to allow marketing of the product for prevention of heart attacks in patients with no prior history of cardiovascular disease.

The regulator stated yesterday that “after carefully examining scientific data from major studies, FDA has concluded that the data do not support the use of aspirin as a preventive medicine by people who have not had a heart attack, stroke or cardiovascular problems, a use that is called ‘primary prevention.'”

FDA did state, however, that “the available evidence supports the use of aspirin for preventing another heart attack or stroke in patients who have cardiovascular disease or who have already had a heart attack or stoke.”

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

FDA lifts OncoMed partial hold

The FDA froze the clinical trial of anti-Fzd7 vantictumab in July over concern about "bone-related adverse events."

Research links estrogen and binge eating

Baylor College of Medicine researchers have found that an estrogen replacement suppressed binge-eating behavior among lab mice.

Apple selfies spur diabetes donations

Jazz apples has launched a Crunch to Contribute campaign to raise money for one of two diabetes associations.