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FDA: Toughen Warning Language on NSAIDs- Pain News

FDA: Toughen Warning Language on NSAIDs- Pain News

The U.S. Food and Drug Administration (FDA) is increasing its warning for popular pain relievers, saying that they increase the risk of heart attack and stroke.

The changes apply to prescription non-aspirin, non-steroidal anti-inflammatory drugs or NSAIDs as they are best known. The drugs work by blocking the production of prostaglandins, chemicals in the body that cause pain and inflammation. NSAIDs are available by prescription and over the counter. 29 million Americans regularly take them. Here’s the FDA Drug Safety Communication.

If you have back pain (like me), arthritis or even gout, chances are you are taking one of these. Many take them for simple cold and flu symptoms as well.

Here is the FDA reasoning:

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.

The FDA recommends any patients who have new symptoms of chest pain, trouble breathing, and weakness on one side of the body or slurred speech, while taking an NSAID, should contact a doctor.

By the way, if you are wondering how long NSAIDs have been around, the answer is longer than any of us. Aspirin (which by the way was not included on the FDA warning) was the first NSAID, made in 1897 when German chemist Felix Hoffman and the Bayer Company converted salicylic acid into acetylsalicylic acid.

Are you using an NSAID?

If so, does the word from the FDA change your mind about using them?

Are you going to talk with your doctor about it?

Let us know in the comments section.


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