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FDA Strengthens NSAID Warnings

The U.S. Food and Drug Administration (FDA) recently strengthened its warnings regarding nonsteroidal anti-inflammatory drugs (NSAIDs). The agency will require medication labels to indicate that NSAIDs can increase the chance of a heart attack or stroke, either of which can lead to death.

The FDA added a boxed warning (the most serious mandated by the FDA) to prescription NSAID drug labels in 2005. According to the agency, more recent data has prompted it to update NSAID labeling to clarify that the risk of heart attack and stroke may occur early in treatment. In addition, the risk might increase the longer people take NSAIDs.

“There is no period of use shown to be without risk,” Judy Racoosin, M.D., M.P.H., deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products, stated in the FDA’s Consumer Update.

The new warning labels must also emphasize that individuals who have cardiovascular disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk for serious complications associated with NSAID use. "In basic, sufferers with heart disease or danger aspects for it have a higher likelihood of heart attack or stroke," the FDA stated.

The new FDA requirements will apply to over-the-counter and prescription drugs, which are taken by millions of Americans. NSAIDs are commonly used to treat a range of health issues, including pain, inflammation and fever. Common brand names include Aleve, Advil, Motrin, and Celebrex.

According to the FDA, consumers can still take NSAIDs but should be aware of this increased risk of heart attack or stroke, especially at higher doses. The agency further cautions that consumers should stop taking NSAIDs and seek medical help if they experience symptoms that might signal heart problems or stroke, such as chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech.

If you or someone you love has been seriously injured by a dangerous or defective drug, don’t hesitate to contacta San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.