FDA Urged To Expand Aspirin Indications

The US Food and Drug Administration's Nonprescription Drugs andCardiovascular and Renal Drugs Advisory Committees have urged the agency to expand the indications of aspirin to include patients at high risk from heart attack or stroke, including those who have undergone revascularization procedures and others with manifested symptoms of coronary heart disease.

The members of the committee also suggested that the recommended dose of aspirin for the prevention of cardiovascular disease be dropped, as studies have confirmed its efficacy at lower levels.

"Benefits Outweigh Risks" Although aspirin is well-documented to be linked with gastrointestinal disorders, studies have indicated that this prevents only around 6% of people from taking the drug. In addition, buffered and enteric formulations can help to minimize these problems. Data presented at the meeting demonstrated that the benefits of aspirin were greater than the risk of gastrointestinal bleeding or stomach upset, which were said to be "relatively rare and insignificant side effects when compared to aspirin's life-saving effects."