FDA Strengthens NSAID Warning for Heart, Stroke Risks

The US Food and Drug Administration (FDA) has strengthened an existing label warning that nonaspirin nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk for heart attack or stroke, according to an agency alert sent today.

Following a comprehensive review of new safety information, the FDA is requiring the drug labels of all prescription and over-the-counter (OTC) NSAID to be updated to reflect the increased risk. Prescription and OTC nonaspirin NSAIDs already include information about the risk for heart attack and stroke with NSAIDs, either of which can lead to death, the FDA states in a news release.

Prescription nonaspirin NSAID labels first included “Boxed Warning” and “Warnings and Precaution” sections in 2005. Since that time, the FDA reviewed new safety information on prescription and OTC NSAIDs that included observational studies, a large combined analysis of clinical trials, and other scientific publications.

Read the full report here.