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FDA warns of early MI, stroke risk with non-aspirin NSAIDs


MI and stroke risk can rise just weeks after NSAID use commences. Labels will be updated to reflect this.

FDA has strengthened the drug label warning that non-aspirin nonsteroidal anti-inflammatory drugs can increase the risk of myocardial infarction and stroke as early as within the first weeks of use. Longer use and high-dose NSAIDs may increase the risk, according to an FDA Drug Safety Communication on July 9.

“Estimates of increased risk range from 10 percent to 50 percent or more, depending on the drugs and the doses studied,” FDA noted.

The original risk of heart attack and stroke associated with NSAID use was added to prescription NSAIDs in 2005. Since then, FDA has reviewed more safety data on prescription and OTC NSAIDs from analysis of observational studies and clinical trials. This information was discussed at the joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee in February 2014.

The new prescription NSAID labels will be updated to include the following information:

· Myocardial infarction and stroke can happen as early as the first weeks of NSAID use, and the risk may climb with longer use of these drugs.

· Higher doses of NSAIDs appear to increase the risk of myocardial infarction and stroke.


· It is not clear if the risk of myocardial infarction and stroke is similar for all NSAIDs. There is not sufficient evidence that demonstrates that the risk for a certain NSAID is higher or lower than another NSAID.

· Patients with and without heart disease or risk factors for heart disease are at increased risk for these cardiovascular events with NSAID use.

· However, patients with heart disease or risk factors for heart disease have a greater risk of myocardial infarction and stroke with NSAID use compared with those without heart disease.

· Patients who have had a first heart attack and are treated with NSAIDs in the first year following the cardiovascular event are more likely to die than those who were not treated with NSAIDs after the first heart attack.

· NSAID use is associated with an increased risk of heart failure.

FDA plans to request similar revisions to the drug fact labels of OTC NSAIDs.

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