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The U.S. Food and Drug Administration (FDA) issued a warning to users of the over-the-counter pain reliever Naproxen on Monday, after federal researchers found an increased risk of heart attacks and strokes among users. According to reports from CNN.com and Medscape Medical News on December 21, 2004, Naproxen is the latest in a group of nonsteroidal anti-inflammatory drugs (NSAIDs) linked to cardiovascular issues.

This warning followed a study sponsored by the National Institute on Aging, which tested whether Celebrex or Naproxen could reduce the risk of Alzheimer’s disease. The study was halted after researchers observed a 50% higher incidence of heart attacks and strokes among participants taking Naproxen.

In light of these findings, the FDA advised users to contact their doctors and avoid using Naproxen for longer than 10 days. Helmut Schdefers, a spokesman for Bayer Healthcare AG, agreed with the FDA’s recommendation, saying, “We are in agreement with FDA regulators that people taking Aleve should consult their doctors and avoid taking the drug for more than 10 days.” Schdefers also highlighted concerns over Aleve, noting that it is an over-the-counter drug.

David Graham, an FDA drug safety researcher and whistleblower, told CNN, “Over-the-counter drugs are supposed to be the safest.” He further questioned the FDA’s response, stating, “I think this asks the larger question, ‘Why has the FDA not done the job it needs to do to protect America from unsafe drugs?’” Graham, who worked at the FDA for 20 years, expressed concerns that “safety has been at the back of the bus, if it’s on the bus at all.”