Nonsteroidal anti-inflammatory drugs such as Celebrex, Advil, Aleve and Motrin IB have long had warnings on their labels about them possibly increasing the risk of heart attacks and strokes, but after follow-up studies from the Food and Drug Administration, the latest FDA painkillers regulations state that this is not a possibility but rather a fact.
NSAIDs included in the new FDA painkillers regulations include ibuprofen (such as Advil), naproxen (Aleve) and even prescription drugs such as COX-2 inhibitors, including brand name Celebrex, while Tylenol (acetaminophen) isn't included in the category, nor is aspirin; in any case, the new regulation applies to both prescription and over-the-counter drugs.
According to NBC News, the new FDA painkillers regulations call out for NSAID levels to be changed from the wording "may cause" problems such as heart attack and strokes to "cause," after the administration found serious side effects associated with these drugs, with increased risk even after only using the medication for a few weeks.
The Wall Street Journal reports that the FDA painkillers regulations have officially called for prescription drugs' labels to be changed, and they'll be starting a similar process with their over-the-counter (OCT) versions, although the change of these drugs' labels is done in a different way.
"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 NSAIDs," reads the recent statement regarding FDA's painkillers regulations. "FDA is adding information in the drug label for people who already have had a heart attack. 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."
While the labeling change takes place following the new FDA painkillers regulations, the agency asks consumers to study drugs they're taking beforehand, to try to avoid further issues with high risks.
