FDA Strengthens Warning For NSAIDs

The U.S. Food and Drug Administration (FDA) on July 9 announced that it will strengthen the warning for heart attack and stroke risk on nonsteroidal anti-inflammatory drug (NSAIDs) labels (both over-the-counter and prescription drugs). The agency further advised that consumers should not take multiple products that contain NSAIDs at the same time.

According to recent research, the risk of heart attack and stroke can occur as early as the first week of treatment while taking NSAIDs and those with cardiovascular disease are at the greatest risk. This risk increases with higher doses and longer use of NSAIDs.

The FDA will require updated information on the increased heart attack and stroke risk on prescription NSAID product labels, including information for patients who have previously had a heart attack. The agency has also requested that over-the-counter NSAID manufacturers add the updated risk warning to Drug Fact labels.

“This recent FDA advisory strengthens the warning that the use of over-the-counter non-aspirin NSAIDs increases the chances of a heart attack or stroke,” said Salim S. Virani, MD PhD, FACC, of the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine Houston, TX. “The risk seems to be increased in both those with or without prior history of cardiovascular disease although, the risk is higher in those with prior history of cardiovascular disease. The harmful effects appear to be dose dependent and can occur as early as the first weeks of using NSAIDs. This combined with known increased risk of nephrotoxicity (kidney damage) with NASAID use highlights the need for patients to discuss the use of NSAIDs (along with other over-the-counter medications) with their providers who can identify other possible alternatives which might be safer. This is extremely important as these drugs are available over the counter and therefore, public health implications are likely large.”

Read the FDA announcement.

Keywords: Anti-Inflammatory Agents, Non-Steroidal, Cardiovascular Diseases, Drug Labeling, Nonprescription Drugs, Prescription Drugs, Stroke, United States Food and Drug Administration

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