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FDA Warning on NSAIDs: Consider the Risk-Benefit Ratio, Advise Experts


The FDA warning last week on the cardiovascular effects of non-aspirin nonsteroidal anti-inflammatory drugs has prompted healthcare experts to advise caution when using these drugs on a regular basis.

The FDA warning last week on the cardiovascular (CV) effects of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) like Motrin IB, Aleve, and Celebrex, has prompted a debate among healthcare experts: how do we regulate the pill popping phenomenon that has emerged, even for minor aches and pains?

While current labels for both over-the-counter (OTC) and prescription NSAIDs indicate heart risks, the FDA said in its announcement that prescription NSAIDs would need a drug label update to reflect the following:

  • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID, and risk may increase with longer use.
  • The risk appears greater at higher doses.
  • The newer information on NSAIDs is not sufficient to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
  • NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease.
  • In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors.
  • Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
  • There is an increased risk of heart failure with NSAID use.

Although the risk of a heart attack or stroke from NSAID use does not match up with the risks associated with smoking or obesity, it does exist. Peter Wilson, MD, from Emory University in Atlanta who was on the FDA panel last year that evaluated the more recent evidence, said in an interview that while these drugs are widely viewed as benign “they are probably not,” adding that OTC NSAIDs may increase the risk by 10%, low-dose prescription NSAIDs by about 20%, and high-dose prescriptions NSAIDs by about 50%.

However, a lot of variables are yet to be determined, such as safety of one product over another, safe dose or duration of treatment, etc. The lack of additional and more definitive information has prompted experts to recommend that people should weigh the risk-to-benefit with these medications and that the new warnings might encourage pain management without drugs or divert attention to treating the underlying cause of the pain. According to Bruce Lambert, director of the Center for Communication and Health at Northwestern University, “For people who are in the habit of taking these drugs for headaches or mild pain, they might want to reconsider.”

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