FDA Bolsters Warnings About Heart Attack, Stroke Risks for Commonly Used Pain Drugs

On July 9, the Food and Drug Administration (FDA) issued an important safety alert announcing that the agency was strengthening existing warnings in the product labels for all non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) about increased risk of heart attack and stroke.[1]

NSAIDs are used to treat fever and pain, including pain caused by osteoarthritis, rheumatoid arthritis and other inflammatory conditions. They are among the most commonly consumed drugs, and some are available both by prescription and over the counter (OTC). Examples include ibuprofen (ADVIL, MOTRIN IB), naproxen (ALEVE, NAPROSYN) and celecoxib (CELEBREX).

For nearly a decade, labels for prescription NSAID drugs have carried a black-box warning indicating, equivocally, that these drugs may increase the risks of heart attack and stroke, both of which can be fatal. The current warnings further state that these risks may increase the longer NSAIDs are used and that patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

Based upon an extensive review of safety data from numerous studies of NSAIDs, the FDA is requiring that labels for prescription NSAIDs include more definitive and detailed warnings about the increased cardiovascular risks, including the following:[2]

• NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease.
• These risks can occur as early as the first weeks of using an NSAID and may increase with longer use.
• These risks appear to be greater at higher doses.
• Patients with heart disease or risk factors for heart disease have a greater risk of heart attack or stroke following NSAID use than patients without these risk factors.
• Patients who take NSAIDs following a first heart attack are more likely to die in the first year after the event than non-NSAID users.
• NSAIDs increase the risk of heart failure.

The FDA also will request similar updated warnings for OTC formulations of NSAIDs. The FDA’s decision to strengthen the NSAID warnings, which was long overdue, provides an important reminder that new information regarding the safety of drugs continues to accumulate for decades after initial FDA approval. To minimize your risk of serious side effects, take NSAIDs only when necessary, at the lowest effective dose and for the shortest time needed. Finally, Public Citizen's Health Research Group has concluded that low-dose ibuprofen and naproxen are least likely to increase cardiovascular risk.[3] We have also designated celecoxib as Do Not Use.

References

[1] Food and Drug Administration. FDA drug safety communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes. July 9, 2015. http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed July 16, 2015.

[2] Ibid.

[3] Further evidence that CELEBREX Is a Do Not Use drug; new designation of diclofenac (VOLTAREN) as a Do Not Use drug; and other Do Not Use NSAIDs. Worst Pills, Best Pills News. June 2014. /newsletters/view/905. Accessed July 20, 2015.