FDA Orders Stronger Warnings of Heart and Stroke Risks with Common Pain Relievers

FDA Orders Stronger Warnings with Common Pain Relievers

FDA Orders Stronger Warnings with Common Pain Relievers

After reviewing new safety information, the Food and Drug Administration (FDA) has requested drug makers to strengthen warnings that common painkillers like Motrin, Aleve, and Advil can increase the risk of a heart attack or stroke.

These painkillers—nonsteroidal anti-inflammatory drugs—are widely used in both prescription and over-the-counter formulas to treat pain and fever from conditions such as menstrual cramps, headaches, colds, and the flu, and in the long-term treatment of arthritis.

The FDA advises individuals taking any NSAID to be aware of symptoms that could signal a heart attack or stroke, including chest pain, shortness of breath, trouble breathing, weakness in one part or side of their body, or slurred speech. Anyone experiencing such symptoms should seek immediate medical attention. Because both prescription and OTC medicines contain NSAIDs, the FDA says consumers should be careful to avoid taking multiple medications with the same active ingredient.

Dr. Denes Korpas, a cardiologist at the Nebraska Heart Institute and Heart Hospital, said patients ask if one NSAID is “better,” than the others. While some studies suggest Aleve may be better, “the recent studies do not make a difference between those and really they are on the same level,” Dr. Korpas told Nebraska television station 1011 Now.

The FDA is requiring updates to the drug labels of all prescription NSAIDs. NSAIDs affected by the new warnings include brand name and generic drugs such as ibuprofen (Advil, Motrin), naproxen (Aleve), indomethacin (Indocin, Tivorbex), and prescription arthritis drugs such as Celebrex (celecoxib). The Drug Facts labels for over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk, but the FDA will request updates to strengthen the OTC non-aspirin NSAID Drug Facts labels.

The Boxed Warning and Warnings and Precautions sections of the prescription NSAID labels first described the heart attack and stroke risks in 2005. Since then, the FDA has received new safety information on both prescription and OTC NSAIDs, including observational studies, a combined analysis of clinical trials, and scientific publications. All of this information was discussed at a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee in February 2014.

According to the FDA statement, the risk of heart attack or stroke can occur as early as the first weeks of using an NSAID and the risk may increase with longer use. The risk appears greater at higher doses. Though the risk may not be the same for all NSAIDs, the FDA said at this time it does not have enough information to determine whether the risk of a particular NSAID is higher or lower. Patients who take NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who did not take NSAIDs after their first heart attack. There is an increased risk of heart failure with NSAID use, the FDA said.









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