A decade’s worth of research on nonsteroidal anti-inflammatory drugs, or NSAIDs, has prompted the Food and Drug Administration to demand stiffer warnings on the labels of such prescription medications as celecoxib (marketed commercially as Celebrex) and diclofenac (Voltaren) about the increased risk of heart attacks and strokes in those taking the drugs.
Prescription NSAID labels now will alert consumers that the higher risk of stroke or heart attack is evident in the first weeks a patient starts taking such drugs, that the risk appears to escalate at higher doses and with longer use, and that even people with no other cardiovascular risk factors are more likely to suffer heart attack or stroke when taking the medications.
The warnings will also note for the first time that using NSAIDs increases a person’s likelihood of suffering heart failure and that in their first year after a heart attack, patients treated with such medications were more likely to die than heart attack victims who did not take them.
The FDA said that for now, only prescription NSAIDs would be required to add the warnings. But the agency said it would soon ask the manufacturers of over-the-counter NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve) also to update their labels to reflect the stiffer warnings.
Those warnings come a decade after the FDA issued a public health advisory on the use of rofecoxib, better known as Vioxx, after it was found that those taking the medication had higher rates of heart attack and stroke. The pharmaceutical giant Merck subsequently pulled Vioxx from the market.
Several months later, the agency directed that all NSAIDs should carry a boxed warning on their labels alerting consumers to a “potential increased risk of serious adverse (cardiovascular) events.” The FDA also asked Pfizer, manufacturer of a widely prescribed NSAID called Bextra to pull its product off the market.
The new language comes in the wake of renewed scrutiny by the agency of a class of drugs taken by millions of Americans for occasional aches and pains, and widely used to treat chronic conditions such as arthritis.
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