FDA warns of heart attack, stroke risk associated with NSAIDs

After reviewing safety data, the FDA announced on July 9 that prescription non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of heart attack, heart failure and stroke. NSAIDs such as ibuprofen, naproxen, diclofenac and celecoxib are commonly used to treat pain, inflammation and fever.

Labels for NSAIDs will be updated to include warnings that the risk of heart attack or stroke can occur within a few weeks of taking the medications and that the risk may be increased with higher doses. The FDA said it would also request labeling changes for over-the-counter non-prescription NSAIDs such as Advil, Motrin and Aleve.

“There is no period of use shown to be without risk,” Judy Racoosin, MD, deputy director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products, said in a news release.

The labels will indicate the risks occur in patients with or without heart disease or risk factors for heart disease, although people with cardiovascular disease are at the greatest risk for adverse events associated with NSAIDs. Further, the FDA found that patients who received NSAIDs after a first heart attack were more likely to die compared with patients who were not prescribed NSAIDs after a heart attack.

In 2005, the FDA required manufacturers of NSAIDs to include boxed warnings on their labels indicating the risk of heart attack and stroke with NSAIDs. At that time, Pfizer withdrew valdecoxib (Bextra) from the market. In September 2004, Merck voluntarily withdrew another NSAID, rofecoxib (Vioxx), from the market.

The FDA said people taking NSAIDs who experience symptoms such as chest pain, shortness of breath, weakness or slurred speed should seek medical attention immediately.