FDA: Calls for More Warnings on NSAIDS – Ibuprofen, Naproxen – Increase Risk of Stroke and Heart Attack

You develop a terrible headache and you pop an Advil. Nothing safer, right? Think again. NSAIDs may not be as harmless as they seem, leading the US Food and Drug Administration to call for strengthening warning on labels on commonly used painkillers such as naproxen and ibuprofen. The new warnings highlight how these medications have the potential to increase risks for heart attack and stroke. “Everyone may be at risk, even people without an underlying risk for cardiovascular disease,” explains Dr. Judy Racoosin, who is the deputy director of the F.D.A.’s Division of Anesthesia, Analgesia and Addiction Products.

Furthermore, FDA spokesman Eric Pahon notes, “They used to say they might cause risk of heart attack or stroke. Now we are saying they do cause increased risk of heart attack and stroke.” Further, FDA director of the division of nonprescription drug products, Dr. Karen Mahoney, says, “Be careful not to take more than one product that contains an NSAID at a time,” in the agency’s announcement.

She also emphasized the need for patients to analyze all the active ingredients in any drug facts label before popping them in order to make sure they do not contain an NSAID.

Nonsteroidal anti-inflammatory drugs (usually abbreviated to NSAIDs), are a class of drugs that provides analgesic (pain-killing) and antipyretic (fever-reducing) effects, and, in higher doses, even anti-inflammatory effects.As analgesics, NSAIDs are unusual in the sense that they are non-narcotic and thus can easily be prescribed as non-addictive alternative to narcotics. Also, to be noted, is that Paracetamol (acetaminophen) is generally not considered an NSAID because it has only little anti-inflammatory activity. It treats pain mainly by blocking COX-2 mostly in the central nervous system, but not much in the rest of the body – while most NSAIDs work by blocking the COX-1 pathway and also the COX-2 pathway.

What’s frightening is how readily available these medications are over the counter – including ibuprofen (ie Motrin, Advil) and naproxen (Aleve). Some NSAID medications can also show up in other medicines, particularly multi-symptom cold treatments.

In addition – to be noted by heart patients – the FDA did not include Aspirin into the list of drugs with warning labels.

“These medicines have a long history of safety and efficacy when used as directed,” advises the Consumer Healthcare Products Association, an agency which represents nonprescription drug makers. The group did, however, say that it would cooperate with the FDA’s request for the label updates.


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