cardiovascular disease

FDA Strengthens NSAID Cardiovascular Warnings

The FDA has decided to strengthen existing cardiovascular warnings on the labels of prescription non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), and will request updates to the labels of over-the-counter NSAIDs as well.
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After a comprehensive review of new safety information, the FDA has decided to revise the labels of prescription NSAIDs to reflect the following:

  • Elevated risk of heart attack or stroke can occur with NSAID use at as early as 2 weeks, and increases with duration of treatment.
  • The risk is higher at higher doses
  • While risks associated with NSAID use appear to be similar for all NSAIDS, current information is not sufficient to determine whether certain NSAIDS carry higher risks than others
  • NSAIDS can increase heart attack and stroke risk in patients with no cardiovascular risk factors
  • Patients with cardiovascular risk factors have a higher chance of adverse events following NSAID use than those without risk factors
  • Patients treated with NSAIDs after a first heart attack had higher mortality rates in the first year than those not treated with NSAIDs
  • NSAID use increases heart failure risk

“Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken,” the FDA wrote in their safety alert.

“Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.”

—Michael Potts

Reference

FDA. Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs): drug safety communication - fda strengthens warning of increased chance of heart attack or stroke [press release]. June 9, 2015. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm454141.htm.