FDA strengthens heart attack, stroke risk warnings for NSAID pain medications

NSAIDPeople regularly taking a common type of painkiller called an NSAID may be at greater risk for heart attack or stroke than previously thought.

The U.S. Food and Drug Administration (FDA) has strengthened existing warnings of potentially deadly heart attack and stroke risk for a class of pain medications known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAID labeling already warns of these side effects in the long term, but new information has revealed they can occur as early as the first few weeks after using an NSAID.

Additionally, heart attack and stroke risk may increase the longer someone takes an NSAID. People who have cardiovascular disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk for cardiovascular adverse events associated with this type of medication.

“There is no period of use shown to be without risk,” said Judy Racoosin, M.D., M.P.H., deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products, in an FDA announcement.

NSAIDs have long been relied upon for over-the-counter pain relief, and are some of the most common drugs in use today. Household names including ibuprofen (Motrin, Advil) and naproxen (Aleve) are members of this group. Prescription NSAIDs are used to treat several kinds of arthritis and other painful conditions.

Though aspirin is an NSAID, the FDA says these updated warnings do not apply to this medication.

Like many pain medications, NSAIDs are metabolized by genetically variable drug-metabolizing enzymes. The enzyme responsible for NSAID metabolism is called CYP2C9, for which as many as 35 percent of the population could have reduced activity due to genetics. Reduced CYP2C9 activity can lead to higher levels of a given NSAID in the blood, which can result in adverse effects.

The FDA will require drug manufacturers to include more specific warnings of heart attack and stroke risk on both over-the-counter and prescription NSAID packaging in the coming months.

NSAIDs are still effective pain relievers, the FDA says. Consumers can still take them, but should also be aware of the associate risks, particularly in high doses. The FDA offers this advice:

  • Read the Drug Facts label for nonprescription drugs and use the least amount of NSAID-containing medication for the shortest period of time.
  • Do not take more than one medication containing an NSAID at the same time.
  • When using prescription NSAIDs, read the drug safety information in the consumer-oriented Medication Guide attached to the filled prescription.
  • Individuals with heart disease should consult a healthcare provider before using an NSAID.
  • Anyone taking an NSAID experiencing symptoms such as chest pain, trouble breathing, sudden weakness in specific parts of the body or sudden slurred speech (all potential signs of heart problems or stroke) should stop taking the NSAID and seek medical help.
  • Acetaminophen (Tylenol) may be a better alternative for patients who do not have liver disease or chronic alcohol problems. Check with your doctor or pharmacist.

Click here to see the FDA’s full NSAIDs announcement. Additional information on NSAIDs can be found via WebMD.com.