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FDA Orders Stronger Warnings for Motrin, Advil, and Aleve


Non-steroidal anti-inflammatory drugs (NSAIDs) like Motrin, Advil, and Aleve can increase the chance of heart attack or stroke as early of the first few weeks of use, according to the U.S. Food and Drug Administration. As a result, the FDA announced last week that it is strengthening its existing warnings regarding the over-the-counter (OTC) medications.

Non-steroidal Anti-inflammatory Drugs

Over-the-counter NSAIDs are used to temporarily reduce fever and to treat minor aches and pains including:ibuprofen-nsaids-pain-reliever-300x234

  • Toothaches
  • Headaches
  • Backaches
  • Muscular aches
  • Tendonitis
  • Strains
  • Sprains
  • Menstrual cramps

The labels for both prescription and over-the-counter NSAIDs already have information on heart attack and stroke risk, but in the coming months, the FDA plans to require manufacturers of both prescription and OTC NSAIDs to update their labels with more specific information about increased risks.


NSAIDs can cause high blood pressure, which in turn increases the risk of heart attack and stroke, and NSAIDs also have the ability to reduce the effects of blood pressure medication, further increasing the risk. They also cause the body to retain fluid, which can aggravate existing symptoms of heart failure.

Consumers of particular risk include those who have cardiovascular disease, or have recently had a heart attack or coronary bypass surgery, but according to the studies, everyone who takes NSAIDs is at risk. Because numerous prescriptions and OTC medications contain non-steroidal anti-inflammatories, the FDA is advising consumers to avoid taking multiple pain relievers with the same active ingredient.

FDA Warnings

The FDA first issued warnings the prescription NSAIDs in 2005, but decided updated warnings were necessary because more recent data indicates that there is a risk of heart attack and/or stroke occurring within the first few weeks of over-the-counter NSAID use, and the dangerous side effects of the drugs can continue to grow the longer they are used.

The FDA is now adding information on the drug label for those who have already had a heart attack to inform this vulnerable population that they are at increased risk of having another heart attack or suffering death due to heart-attack related caused if they are treated with NSAIDs.


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  1. norma ackerman says:
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    so, tylenol is risky. And Advil is risky. That about covers all of OTC meds. Any ideas on what is not risky to take for chronic pain sufferers?

  2. shar bc says:
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    had 1st migrain-sinus related yrs ago. nothing helped. not even rx or mega doses of otc products. but free trial of aleve stopped it. what do i use now?

  3. Christi says:
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    Seems Bayer is the only choice now being that its great for pain and is chosen to help prevent a heart attack

  4. Christi says:
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    of course, how many people can’t take aspirin? that number is higher than the number of heart attacks caused, statistically

  5. Von says:
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    The FDA just reversed itself on using “baby aspirin” to prevent heart attacks and strokes, finding that it really doesn’t reduce deaths, but does expose the patient to significant risks.