FDA: Toughen Warning Language on NSAIDs

FDA: Toughen Warning Language on NSAIDs

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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Authored by: Ed Coghlan

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Janice Reynolds

Celebrex has some of the risks that the other NSAIDs have but not to the same degree. Celebrex is a Cox II inhibitor. The other NSAIDs inhibit I and II. This enzyme interferes with the production of prostaglandins. This in turn interferes with the protection to the GI lining and Kidney linings. Most cause prolonged bleeding times. The Cox II inhibitors effect the heart in the same way as the Cox I. At any time one must weigh risk vs. benefits which is why it is important for the FDA to require these adverse effects be identified. Unfortunately for a long time there has been the myths that NSAIDs are safer than opioids, over the counter must be safe., and these medications require long term use for adverse effects to occur (as time progresses it increases the likely hood. I had one women tell me in a class I was teaching on pain in the older adults (for older adults) that her doctor said ibuprofen was the safest medication out there. How can she have infirmed consent and weigh risk vs. benefits when she is told something like that?


Have been using celebrex for years and will not change. Tried to eliminate them once and the pain was to much. I guess those of us with chronic pain just have to take our chances.

Mark Ibsen

NSAIDs: dangerous
Gabapentin: dangerous
Opioids: dangerous, but only if you OD
Pain: dangerous
Sounds like a complicated minefield to navigate.
We should maybe leave it to the patient and their physician to cook create a plan that’s workable

Janice Reynolds

It is about time. However they need to toughen language also on risks of kidney failure (I had that happen to me with just the occasional ibuprofen-I take acetaminophen as part of my pain plan so used the ibuprofen for occasional JA or back pain) and GI bleeds (in the late 90’s the leading cause of hospital admissions for older women was GI bleeds secondary to ibuprofen). During the 90’s as a nurse I cared for a 10 month old who went into renal failure and had a GI bleed after two approved doses of ibuprofen for teething. Scary; rare but you won’t see my grandchildren getting ibuprofen. The Alliance for the Rational Use of NSAIDs website has good information. All medication has risks, one just need to be aware of them to decide if the benefits outweigh the risks for them.

Rev. Shawn Smith

I have tried just about all OTC pain relievers none of them worked so my docs first line of defense as Viox (discontinued I belive) didn’t work then celebrex didnt work melixicam.(sp?) didn’t work then prescription strength OTCs didn’t work then a NSAID patch helped a little but insurance didn’t cover it and then a topical ointment with the same NSAID as the Flector patch insurance didn’t cover it
NO will not be taking these medications the risk doesn’t outweigh the bennifets for me .