Stronger Warning Label Placed on Non-Aspirin NSAIDs

Stronger Warning Label Placed on Non-Aspirin NSAIDs

Stronger Warning Label Placed on Non-Aspirin NSAIDs


The warning labels on non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) are being strengthened to reflect the the risk of heart attack and stroke, the U.S. Food and Drug Administration (FDA) announced. The agency already warned of this risk in 2005, but has updated the label after an expert panel reviewed new safety data. NSAIDs, which are available in many over-the-counter (OTC) products such as Advil, Motrin and Aleve, are widely used. Raising awareness about potential risks is important and wide-reaching.

The revised warning says that the painkillers may increase the risk of stroke or heart attack in the first few weeks and that the risk can increase when they are used for longer periods. The risk also increases with higher doses. The revised label will also reflect that patients with or without heart disease or other risk factors can face an increased risk of stroke or heart attack with NSAID use, although patients with risk factors or heart disease are more likely to experience these events. The FDA notification states that “A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.”

Patients who are taking NSAIDs after having a heart attack for the first time have a higher risk of death is higher in the first year after the heart attack compared to those not taking NSAIDs after a first heart attack, the new warning says.

According to the FDA it was thought that the risk of heart attack and stroke were similar with all NSAIDs. However, the new warning states that this may not be the case but there is currently insufficient evidence to de

    termine if one NSAID is more dangerous than the others.

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