FDA Strengthens Heart Attack Warnings on NSAID Painkillers

July 10, 2015 — The FDA is strengthening warnings about the risk of heart attack and stroke from painkillers in the non-steroidal anti-inflammatory drug (NSAID) class.

NSAIDs include ibuprofen (Advil, Motrin), naproxen (Aleve), and celecoxib (Celebrex). They are used to treat pain, inflammation, and fever.

Labels on NSAIDs have carried warnings about heart attack and stroke since 2005, when the agency pulled Vioxx off the market due to cardiovascular concerns. The wording on the label will be changed from “may cause” to “cause” heart problems.

According to the FDA, the increased risk of heart attack or stroke can occur in the first few weeks of taking an NSAID, and increase the longer the drug is taken — especially at higher doses. People with a history of heart problems have the greatest risk, but even people without risk-factors can develop heart problems from NSAIDs.

Heart problems linked to NSAIDs include:

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

Heart problems are not the only life-threatening side effects linked to NSAIDs. In September 2014, a study published in Rheumatology found that patients on NSAIDs were 80% more likely to develop venous thromboembolism than non-users. Other studies have found higher rates of gastrointestinal bleeding.

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