FDA Changes Warnings on Ibuprofen and Other NSAIDs

By Rheingold Giuffra Ruffo & Plotkin LLP

For the past few years, the FDA has warned that ibuprofen, naproxen, and other NSAID (nonsteroidal anti-inflammatory drugs) type painkillers may cause an increase of risk for heart disease and stroke. Now the FDA has strengthened its warning and says that these drugs absolutely do raise the risk for heart attack and stroke.

According to an FDA spokesman, the “FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) drug facts labels to indicate that non-steroidal anti-inflammatory drugs can increase the chance of a heart attack or stroke, either of which can lead to death.”

A large number of studies were reviewed that supported this conclusion, estimating that the relative risk increased by 10%-50%, depending on the drugs and the doses in question.

Frequently used NSAIDs include ibuprofen (sold as Advil or Motrin), naproxen (Aleve), as well as COX-2 inhibitors (ex. Celebrex). They are used to temporarily reduce fever and to treat minor aches and pains such as headaches, backaches, muscle aches, toothaches, sprains, strains, tendonitis, and menstrual cramps.

Consumers can still take these medications, but ought to be aware of the increased risk of heart attack and stroke, especially at higher dosages.

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