Naproxen Associated with Cardiovascular Disease, FDA Issues Warning The United States Food and Drug Administration (FDA) has issued an alert to people that use the over-the-counter pain reliever Naproxen Monday just after federal researchers discovered a greater number of heart attacks and strokes among consumers. As outlined by stories in the December 21, 2004 CNN.com and the Medscape Medical news of the same date, Naproxen may be the most recent of the nonsteroidal anti-inflammatory drugs (NSAIDs) that have now been connected to a rise in cardiovascular problems.
This particular warning came following a investigation sponsored by the National Institute on Aging testing whether Celebrex or Naproxen could lessen the danger of Alzheimer's disease was halted when researchers noted a 50% greater incidence in heart attacks and strokes among participants who were taking Naproxen.
Because of this the FDA now urged consumers to get hold of their particular doctors and to avoid taking the medication for longer than 10 days. Helmut Schdefers, a spokesman for Bayer Healthcare AG, stated, "We have been in agreement with FDA regulators that people taking Aleve should consult their doctors and avoid taking the drug for more than 10 days. Aleve is particularly disturbing because it's an over-the-counter drug."
David Graham, FDA drug safety researcher and whistleblower, told CNN, "Over-the-counter drugs are supposed to be the ones that are the absolutely safest." Graham then questioned the FDA by saying, "I think this asks the larger question, 'Why has FDA not done the job it needs to do to protect America from unsafe drugs?' " Graham stated in his 20 years at the FDA, "safety has been at the back of the bus, if it's on the bus at all."