FDA strengthens warning that NSAIDs increase heart attack and stroke risk

Gregory Curfman, MD

Assistant Professor of Medicine, Former Editor-in-Chief, Harvard Health Publishing

Back in 2005, the FDA warned that taking nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen increased the risk of having a heart attack or stroke. In July 2015 the FDA took the unusual step of further strengthening this warning. This was done on the advice of an expert panel that reviewed additional information about NSAIDs and their risks. Because ibuprofen (Motrin, Advil) and naproxen (Aleve) are available over-the-counter and so widely used, it’s important to be aware of the ibuprofen warnings and naproxen warnings and to take steps to limit the risk

Many people take NSAIDs to relieve mild to moderate pain. These medications may be particularly effective in conditions in which pain results primarily from inflammation, such as arthritis or athletic injury. While you can buy ibuprofen and naproxen on your own, doctors commonly write prescriptions for celecoxib (Celebrex), diclofenac (Cataflam, Voltaren) and other NSAIDs. Aspirin is also an NSAID, but it does not pose a risk of heart attack or stroke. In fact, aspirin is commonly used to prevent heart attacks and strokes. So, it is not covered by this warning.

NSAIDs may also elevate blood pressure and cause heart failure. The risk of heart attack and stroke achieved special notoriety with rofecoxib (Vioxx), a type of NSAID called a COX-2 inhibitor. It caused as many as  140,000 heart attacks in the U.S. during the five years it was on the market (Vioxx was removed from the market in 2004). The regrettable experience with Vioxx raised awareness about the cardiovascular risk of NSAIDs, and led to further studies showing that the risk is not limited to Vioxx but is associated with all NSAIDs.

The FDA has noted the following ibuprofen warnings and naproxen warnings along with similar risks of other NSAIDs:

  • Heart attack and stroke risk increase even with short-term use, and the risk may begin within a few weeks of starting to take an NSAID.
  • The risk increases with higher doses of NSAIDs taken for longer periods of time.
  • The risk is greatest for people who already have heart disease, though even people without heart disease may be at risk.

Using NSAIDs safely

Taking an NSAID for a headache, or for a few days to ease a sore shoulder isn’t likely to cause a heart attack or stroke. It’s more prolonged use that can get risky.

In view of the warnings, it is best for people with heart disease to avoid NSAIDs if at all possible, and for everyone who is considering taking an NSAID to proceed with caution. Here are some strategies:

  • It’s important to take the lowest effective dose, and limit the length of time you take the drug.
  • Never take more than one type of NSAID at a time. There appears to be risk associated with all types of NSAIDs.
  • Try alternatives to NSAIDs such as acetaminophen. It relieves pain but does not appear to increase heart attack or stroke risk. However, acetaminophen can cause liver damage if the daily limit of 4,000 milligrams is exceeded, or if you drink more than three alcoholic drinks every day.
  • If nothing else works and you need to take an NSAID for arthritis or other chronic pain, try taking week-long “holidays” from them and taking acetaminophen instead.
  • If you experience chest pain, shortness of breath, or sudden weakness or difficulty speaking while taking an NSAID, seek medical help immediately.

Related Information: Harvard Heart Letter


  1. Babel

    Elegant way to push naproxen( Aleve )
    once it was subliminal publicity , now they use articles like this one. Where is the truth?!

  2. Jim Fitzsimmons

    I’ve got a stent in my right coronary artery and hvae been taking ranexa for angina as well as altace , toprol, and zocor for 10 yrs.
    But now I have developed severe OA in my hands , wrists, neck,and back. I have used tylenol, ultram, and celebrex.
    Celebrex works great, but sometimes gives me heart pressure or slight pain. I try to alternate on a day and off a day with it . Any ideas?

  3. Jonathan fortin

    I was just wondering. My dad has been prescribed add Ville for Joint pain. I need takes two pills daily what type of affects with this lead to in the long-term


    Thank you very much for serving and information.
    healthy and successful greeting always

  5. Bill

    What are long term (2 yrs.) affects of taking Acetiminafin /Hydrocodone HCL 5-325
    1 and 1/2 pills / day?

  6. Bill Bale

    Is there a better anti- inflammatory or one that is equivalent to Celebrex?

    • Craig

      If you live in one of the many states that now allow it, the Cannabidiol (CBD) Oil that is used for Epilepsy, Alzheimer’s and other brain and inflammation issues, works well for muscle and joint pain too. It is all natural, so the positive side effects may surprise you. And as always, do your research first!
      There are many good studies available on the National Institute of Health database (PubMed)…

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