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The FDA requires drug makers to strengthen warning labels for NSAIDs

The Food and Drug Administration (FDA) announced new data showing that nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increase in the risk of heart attack and stroke. Serious side effects and increased risk of heart attack and stroke can occur as early as the first few weeks of treatment.

The FDA will require makers of this class of drugs to strengthen and update prescription labels to state they cause an increased risk of heart attack or stroke. Previously, in 2005, the FDA required a boxed warning be listed on NSAIDs stating they may cause risk.

Over-the-counter (OTC) drugs including generic ibuprofen, naproxen (Aleve), diclofenac, and meloxicam will be required to make similar changes to their labels in the upcoming months. OTC drugs have a different regulatory procedure than prescription drugs. Tylenol is an acetaminophen and does not fall into the NSAIDs class.

Prescription NSAIDs are used in treating symptoms of rheumatoid arthritis such as pain, swelling, stiffness, and minor inflammation. (It is important to keep in mind that NSAIDs have no effect on the long-term damage to joints that can result from chronic inflammation associated with RA.) NSAIDs are also used to help manage symptoms of other conditions such as multiple sclerosis, osteoarthritis, gout and other rheumatological and painful conditions. OTC drugs are used for temporary pain relief and reducing fever and inflammation.

The FDA recommends for patients who have high blood pressure or heart disease to consult their doctor before using an NSAID.1,2,3 While most people do not use NSAIDs for migraine, we thought this information important enough to share with the community, especially for those who do use NSAIDs.

As always, do not stop, start, or change any treatment without first discussing with your healthcare provider.

For more information, visit the FDA consumer update.

  1. Burton T. FDA Strengthens Warnings on Class of Popular Painkillers. The Wall Street Journal. Published July 9, 2015. Accessed July 10, 2015.
  2. FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs. FDA. Published July 9, 2015. Accessed July 10, 2015.
  3. Fox M. FDA Strengthens Heart Safety Warnings on Painkillers. CNBC. Published July 9, 2015. Accessed July 10, 2015.


  • Carla Kienast
    4 years ago

    My husband, who has had a triple bypass, is prohibited from taking any NSAIDs or even using Voltaren, which is an NSAID in gel form. Interestingly, when my liver enzymes were recently elevated, I was also warned against taking any NSAIDs because they can also affect liver function. They’re great, but like with any medication, must be taken with care.

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