FDA strengthens warning that NSAIDs increase heart attack and stroke risk - Harvard Health Blog - Harvard Health Publications

It remains the case that Naproxen (Aleve) is probably safer than the other NSAIDS. That evidence, of course, was the basis for the plaintiffs verdicts against Merck in the Vioxx cases. - gwc

FDA strengthens warning that NSAIDs increase heart attack and stroke risk - Harvard Health Blog - Harvard Health Publications

POSTED JULY 13, 2015, 4:16 PM

Gregory Curfman, MD, Editor in Chief, Harvard Health Publications

Back in 2005, the FDA warned that taking nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen increased the risk of having a heart attack or stroke. Last week it took the unusual step of further strengthening this warning. This was done on the advice of an expert panel that reviewed new information about NSAIDs and their risks. Because NSAIDs are widely used, it’s important to be aware of downsides of taking an NSAID and to take steps to limit the risk.

Many people take NSAIDs to relieve mild to moderate pain. These medications may be particularly effective in conditions in which pain results primarily from inflammation, such as arthritis or athletic injury. Examples of commonly used over-the-counter NSAIDs include ibuprofen (Motrin, Advil) and naproxen (Aleve); celecoxib (Celebrex), diclofenac (Cataflam, Voltaren) are prescription NSAIDs. Aspirin is also an NSAID, but it does not pose a risk of heart attack or stroke and is not covered by this new warning.

For more than 15 years, experts have known that NSAIDs increase the risk of heart attack and stroke. They may also elevate blood pressure and cause heart failure. The risk of heart attack and stroke achieved special notoriety with rofecoxib (Vioxx), a type of NSAID called a COX-2 inhibitor. It caused as many as 140,000 heart attacks in the U.S. during the five years it was on the market (Vioxx was removed from the market in 2004). The regrettable experience with Vioxx raised awareness about the cardiovascular risk of NSAIDs, and led to further studies showing that the risk is not limited to Vioxx but is associated with all NSAIDs.

The new warnings from the FDA point out:

• Heart attack and stroke risk increase even with short-term use, and the risk may begin within a few weeks of starting to take an NSAID.
• The risk increases with higher doses of NSAIDs taken for longer periods of time.
• The risk is greatest for people who already have heart disease, though even people without heart disease may be at risk.
• Previous studies have suggested that naproxen may be safer than other types of NSDAIDs, but the new evidence reviewed by the expert panel isn’t solid enough to determine that for certain.