NSAIDs Warning

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The FDA recently strengthened the warning on a group of the most commonly used prescription and over-the-counter medications. These drugs, known as nonsteroidal anti-inflammatory drugs, or NSAIDs, include popular painkillers like ibuprofen and naproxen.

NSAIDs have carried warnings for years about potential risks of heart attacks and strokes. The new warning comes in light of new safety information on both over-the-counter and prescription forms of the medications and the FDA determined that the risks are greater than originally believed. The risk applies to even short-term use of these medications and it’s true for people with or without heart disease.

The body reacts to certain types of injuries by producing inflammation. Though we often see inflammation as a bad thing, it is in fact the body’s method of starting the healing process. At the site of injury, chemical substances and specific proteins are released to signal the rest of the body to send repair cells. One group of these proteins is called cyclooxygenases (COX). These proteins in turn promote the production of other substances that are involved in healing the damaged tissue.

NSAIDs act in the body to block the COX proteins, thereby reducing inflammation. By blocking these substances, the drugs also block the release of other chemicals that produce pain by exciting the nerves in the area.

Researchers say the risk of heart attack or stroke with this class of medications has to do with the way they interact with the blood platelets. Platelets are blood cells that help the blood to clot and prevent bleeding.

Aspirin is also an NSAID. However, it is not included in the warning because it works differently from other NSAIDs. Aspirin blocks an enzyme that prevents platelets from clumping together and forming dangerous clots, blood clots that can lead to heart attacks and strokes. The non-aspirin NSAIDs work on that enzyme, too, but also affect another enzyme that promotes clotting.

Therefore, new labeling of these medications will 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.
  • 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.

The content in this column is for informational purposes only. Consult your physician for appropriate individual treatment. Dr. Reynolds practices Family Medicine in Chesterfield.

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