How Safe Is Your NSAID?

New FDA Warning on Heart Attack and Stroke Risk, Raises Questions About How Safe Are NSAIDs.

Before you reach into the medicine cabinet to relieve your headache, backache, or arthritis, take note! FDA strengthened the warning on prescription and over-the-counter (OTC) labels that NSAIDs (nonsteroidal anti-inflammatory drugs) can increase the chance of a heart attack or stroke, either of which can lead to death.

Pain patients taking either OTC or prescription versions of NSAIDs should be aware of adverse events associated with these commonly used medications, especially if you have  pre-existing cardiovascular conditions or history of gastrointestinal bleeding. Therefore, NSAIDs should be limited to the lowest dose and shortest duration due to the risk of gastric distress, ulceration, bleeding, increased risk of cardiovascular events, and kidney toxicity.

To address these concerns, pharmaceutical companies have been investigating new delivery systems. Recently, Iroko Pharmaceuticals has gained approval of three new formulations of NSAIDs that contains submicron particles of the NSAID that are approximately 10 times smaller than their original size. This smaller particle size provides an increased surface area, leading to faster dissolution, thus "allowing clinicins to prescribe the lowest effective dose of NSAIDs for the shortest possible duration," noted the company. The three new products include Vivlodex (meloxicam), Zorvolex (diclofenac) and Tivorbex (indomethacin).

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, noted the agency. These serious side effects can occur as early as the first weeks of using an NSAID and the risk may increase the longer you are taking an NSAID. The risk appears greater at higher doses; use the lowest effective amount for the shortest possible time.

The recent FDA announcement is based on the agency’s comprehensive review of new safety information. “As is the case with current prescription NSAID labels, the Drug Facts labels of OTC non-aspirin NSAIDs already contain information on heart attack and stroke risk. The FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels,” noted a release from the agency.

Based on the FDA review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:

  • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
  • The risk appears greater at higher doses.
  • It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us 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. 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.
  • 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 because they have a higher risk at baseline.
  • 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.

Many medicines contain NSAIDs, including those used for colds, flu, and sleep, so it is important to read the labels and avoid taking multiple medicines that contain NSAIDs.

Patients who take low-dose aspirin for protection against heart attack and stroke should know that some NSAIDs, including those in OTC products such as ibuprofen and naproxen, can interfere with that protective effect.


Updated on: 01/28/16
Continue Reading:
GI Bleeding and NSAIDs