The new warnings highlight how these medications have the potential to increase risks for heart attack and stroke.
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What’s frightening is how readily available these medications are over the counter – including ibuprofen (ie Motrin, Advil) and naproxen (Aleve). For a very long time now, it has required a warning on the class of drugs which said that they “may cause” an enhanced risk.
The labeling transform is the most current step in the FDA’s ongoing security assessment of the drugs, which stretches back to 2004. Meanwhile, the prescription drugs belong to the cluster that treat different types of arthritis and several other painful conditions.
The FDA wants to issue a big reminder that, from the first weeks you begin using an NSAID, there’s an increased chance of heart attack and stroke. In 2004, Merck & Co Inc. pulled out Vioxx off of the market because it has been tied to heart attack and stroke. The FDA made sure to point out that everyone could be at risk.
There are also likely risks for everyone, whether you’re already prone to other cardiovascular events or not.
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. Consumers can still take them but should be aware of this increased risk of heart attack or stroke, especially at higher doses.
It was believed that all NSAIDs had a similar risk, but recent evidence calls that into question.
“Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken”, said the FDA in the safety alert.
These medicines have a long history of safety and efficacy when used as directed.
Those drugs now warn patients to take the lowest dose possible for as short a period as possible.
When using prescription NSAIDs, read the consumer-friendly Medication Guide attached to your filled prescription, which provides important safety information. “If you take low-dose aspirin for protection against heart attack and stroke, you should know that some NSAIDs, including ibuprofen and naproxen, can interfere with that protective effect”. The updated information with medication containing NSAID will be more specific in its risks of heart attacks and strokes.
Stop taking NSAIDs and seek medical help if you experience symptoms that might signal heart problems or stroke, such as chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech.
The risk seems to be higher at higher doses.
That inconclusive advice came after the FDA advisory panels considered the findings of three published studies – all meta-analyses – that found patients taking naproxen had fewer heart attacks and strokes than those taking ibuprofen or celecoxib. “If you smoke, work on quitting”.
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This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
