The Strongest Label Warning to Non-Aspirin NSAIDs Following a review of new safety information, the U.S. Food and Drug Administration (FDA) has placed stronger warnings about the risk of heart attack and stroke on the labels of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs).
NSAIDs are pain relievers that are available both over-the-counter and as a prescription. Common OTC NSAIDs include Advil, Motrin and Aleve; Celebrex is a prescription NSAID.
The new warning, to be placed on NSAIDs other than aspirin, will contain stronger warnings about the risk of heart attack and stroke.
The FDA already warned about this risk in 2005, but the agency decided to implement a stronger warning following the advice of an expert panel. Since NSAIDs are commonly used, it’s important to be aware of any potential risks.
Previously, it was thought that the risk of heart attack and stroke were similar with all NSAIDs. The new warning, however, states that this may not be the case but there is currently insufficient evidence to determine if one NSAID is more dangerous than the others.
Use of NSAIDs may increase the risk of stroke or heart attack in the first few weeks
Use of NSAIDs may increase the risk of stroke or heart attack in the first few weeks, according to the new warning. The risk increases when the painkiller is used for longer periods. Higher doses can also increase this risk.
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.”
The new NSAID warning label states that the drugs can increase the risk of heart failure. The strengthened warning also addresses patients who are taking NSAIDs after having a heart attack for the first time; in these patients, the risk of death is higher in the first year after the heart attack compared to those not taking NSAIDs after a first heart attack.