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FDA Warns NSAID Painkillers Cause Heart Attack, Stroke

July 10, 2015 — The labels on some of the most popular painkillers are being updated to emphasize the increased risk of heart attack and stroke, according to an annoucement from the FDA.

The warnings will be updated on non-steroidal anti-inflammatory drugs (NSAIDs), which are used to treat pain, inflammation, fever, and diseases like arthritis. Some of the most popular NSAIDs are ibuprofen (Advil, Motrin), naproxen (Aleve), and celecoxib (Celebrex).

The labels on these drugs have included warnings about heart attack and stroke since the FDA pulled Vioxx off the market in 2005 over concerns about cardiovascular side effects. However, the label will be changed from “may cause” to “cause” heart problems.

A number of recent studies have suggested the risk is higher than expected. Heart attacks and strokes can occur after just a few weeks of taking NSAIDs. The risks increase substantially the longer a patient takes NSAIDs, especially at high doses. The risk increases even further for patients with a history of heart problems, but everyone on NSAIDs is at risk.

NSAIDs have been linked to heart problems, such as:

  • High blood pressure
  • Heart failure
  • Heart attack
  • Stroke

These are not the only serious side effects linked to NSAIDs in recent studies. Last year, one study found that the painkillers can lead to gastrointestinal bleeding. Another study published in Rheumatology found an 80% increased rate of venous thromboembolism (blood clots) among certain patients on NSAIDs.

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