FDA denies upgrade in aspirin’s labeling

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It may be a bitter pill to swallow, but the FDA rejected Bayer’s bid to change the labeling for aspirin to include primary prevention of a first heart attack in some at-risk patients.

For more than a decade, Bayer Healthcare and others have petitioned the FDA to allow a label revision for aspirin to include doses of 75 mg to 375 mg for primary prevention of a first MI in patients with a risk of 10 percent or more over 10 years for heart disease or whose physicians have conducted a positive risk-benefit assessment. The FDA has supported the use of aspirin as a secondary prevention of cardiovascular events in patients with established coronary or cerebrovascular disease.

Aspirin makers received the go-ahead to include the secondary prevention labeling in a final rule in 1998. In 2003, advocates of aspirin for primary prevention submitted a citizen petition to the FDA, citing guidelines from the U.S. preventive Services Task Force and the American Heart Association that favored aspirin therapy for primary prevention.

In its denial of the petition, the FDA wrote that it reviewed six clinical trials and pooled analyses and determined that the evidence was not sufficient to support the claim of primary prevention. It reiterated that it “heartily endorsed” the use of aspirin as secondary prevention in appropriate patients under the supervision a healthcare provider.