Feds Issue Stronger Warning Against Some Kinds of Pain Relievers

For some people, it’s almost a reflex to reach for the ibuprofen when they’re hurting. But the FDA has strengthened its warning on these over-the-counter (OTC) drugs because they might increase the risk of heart attack and stroke.

Although these popular drugs currently bear packaging that says they “may cause” an increased risk of heart attack and stroke, new data showing stronger evidence of cardiac problems prompted the feds to make the warnings more forceful.

The affected medicine is in a class known as NSAIDs (nonsteroidal anti-inflammatory drugs). Brand names include Advil, Motrin IB and Aleve.

Millions of Americans rely on the OTC pain relievers for a wide variety of soft tissue complaints, such as sore muscles, tendons, ligaments and fascia, which are membranes that sheath muscle and other body parts, as well as joint stiffness. They’re also taken to reduce fever. The prescription versions generally are stronger and are prescribed to treat arthritis and other painful conditions.

As explained in the New York Times, the FDA will request that manufacturers issue new labels that say that the drugs “cause an increased risk” of serious heart failure. The agency also wants them to state that that the risk could occur early in treatment and might increase the longer the patient uses the medicine. The FDA advises people with heart problems to consult their doctor before taking these meds.

People who have heart disease, especially people who recently had a heart attack or stroke, are most at risk, according to the FDA, but the agency said that even people who had never had heart disease were at risk.

The label revision will apply to OTC and prescription forms of the medicine.

The FDA decided the current warning was not strong enough after reviewing a significant number of studies that supported the conclusion that NSAIDs caused increased risk. The studies estimated that the relative risk increased by 10% to 50% percent, depending on which drugs were involved, and at what doses.

In 2005, the FDA first warned of the risk of heart attack and stroke from taking the prescription medicines. Last year, the feds convened a panel of experts to review the studies and evidence that determined its decision this time.

If you’re hurting, before reaching for the ibuprofen, try applying ice or heat. Other options include aspirin, if you’re not at risk for bleeding, or acetaminophen if you have a healthy liver, don’t drink alcohol regularly, and take it in low doses. If you must take NSAIDs, use the smallest dose possible to alleviate your problem, take them only for a short period and check with your doctor if you have any underlying problems.

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