New FDA warning: Over-the-counter pain meds cause increased risk of heart attack & stroke

Wed, 15 Jul 2015 00:12:40 +0000


In 2011, more than 100 million Americans suffered from chronic pain. That’s 31.5% of U.S.’s total population, or nearly 1 out of every 3 Americans.

Do you regularly take such over-the-counter (OTC) pain medication such as Advil and Aleve?

If so, you should know that the Food and Drug Administration (FDA) has issued a new explicit warning that those non-prescription meds carry an increased risk of heart attack and stroke.


Kristin Magaldi reports for Medical Daily that last Thursday, July 9, 2015, after reviewing new evidence regarding health dangers, the FDA issued stronger warnings about the risks of painkillers on labels, specifically over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (most commonly sold as Advil) and naproxen (sold as Aleve).

Those drugs already contain warnings that say they “may cause” an increased risk of heart attack and stroke, but the FDA is mandating new labels that will make the link explicit, stating that they “cause an increased risk” of heart attack and stroke.

Countless studies from the past have proven that painkillers come with a series of health problems, e.g.:

  • A 2013 study examined 600 trials and found that high doses of NSAIDs increase the risk of heart attacks by one-third.
    • Ibuprofen was found to more than double the likelihood of a major coronary event.
    • All types of NSAIDs saw a two- to four-fold increased risk of gastrointestinal problems.
  • A 2014 study found that deaths associated with strokes were 19% higher in patients who had been taking NSAIDs.

The FDA found that the risk of heart problems is present indiscriminate of the duration of taking the drugs or previous health issues. “There is no period of use shown to be without risk,” said Dr. Judy Racoosin, director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products in a statement.

Previous studies have proven that the risk increases when NSAIDs are used in higher doses. Also, the FDA states that those who have underlying heart disease are at an even greater risk of complications. That being said, health hazards exist for everyone. “Today we know that the risk of heart attack and stroke may occur early in treatment, even in the first weeks,” the FDA says.

The FDA also plans to put additional warnings for those who have preexisting heart problems, and have experienced a heart attack in the past. “This vulnerable population is at an increased risk of having another heart attack or dying of heart attack-related causes if they’re treated with NSAIDs, according to studies,” the FDA said.

In order to minimize chances of experiencing heart complications when taking these painkillers, the FDA recommends that you should take the drug at the lowest dose possible, over the shortest span of time you can. Also, it is advised that you consult a doctor to see if you have preexisting high blood pressure or symptoms of possible heart disease.


  1. Schmidt M, Sørensen H, Petersen K, et al. Preadmission use of nonaspirin nonsteroidal anti-inflammatory drugs and 30-day stroke mortality. Neurology. 2014.
  2. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomized trials. The Lancet. 2013.


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