FDA Strengthens Heart Attack and Stoke Warnings for Nonsteroidal Anti-inflammatory Drugs

 FDA Strengthens Heart Attack & Stoke Warnings for NSAIDs

FDA Strengthens Heart Attack & Stoke Warnings for NSAIDs

The Food and Drug Administration (FDA) has strengthened existing warnings on prescription and over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) Drug Facts labels to indicate that the drugs can increase the risk of a heart attack or stroke, which can lead to death.

These side effects can occur as early as the first weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Aspirin is also an NSAID, but the revised warning does not apply to aspirin.) The OTC drugs covered by the revised warning in this group are used for the temporary relief of pain and fever and the prescription drugs are used to treat several kinds of arthritis and other painful conditions. Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple medicines with the same active ingredient.

Prescription NSAIDs are an important treatment for debilitating conditions, including osteoarthritis, rheumatoid arthritis, gout and other rheumatological and painful conditions. OTC NSAIDs are used to temporarily reduce fever and to treat minor aches and pains such as headaches, toothaches, backaches, muscular aches, tendonitis, strains, sprains and menstrual cramps. Common OTC NSAIDs include ibuprofen (Motrin, Advil) and naproxen (Aleve). NSAIDS are also contained in some combination medicines, for example, multi-symptom cold products. Dr. Karen M. Mahoney, deputy director of FDA’s Division of Nonprescription Drug Products, said, “Be careful not to take more than one product that contains an NSAID at a time.”

The labels for both prescription NSAIDs and OTC NSAIDs already give information about heart attack and stroke risk, but in coming months, manufacturers will be required to provide more specific information about heart attack and stroke risks.

The FDA added a boxed warning to prescription NSAID labels for this risk in 2005. More recent data prompts the NSAID label update. “[W]e know that the risk of heart attack and stroke may occur early in treatment, even in the first weeks,” said Judy Racoosin, M.D., M.P.H., deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products. Racoosin says, “There is no period of use shown to be without risk.” People who have cardiovascular disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk for cardiovascular adverse events associated with NSAIDs.

The FDA is adding information for people who already have had a heart attack. Studies indicate that this vulnerable population is at an increased risk of having another heart attack or dying of heart attack-related causes if they are treated with NSAIDs. But the risk is also there for people without cardiovascular disease.

NSAIDs are effective treatments for pain, inflammation and fever and consumers can still take them but should be aware of the increased risks, especially at higher doses. “Consumers should carefully consider whether the drug is right for them, and use the medicine only as directed. Take the lowest effective dose for the shortest amount of time possible,” Mahoney says.

The FDA advises consumers to stop taking NSAIDs and seek medical attention if they experience symptoms that might signal heart problems or stroke. These symptoms include chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech.


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