SILVER SPRING, Md., July 10 (UPI) — The Food and Drug Administration is strengthening warnings on prescription and over-the-counter nonsteroidal anti-inflammatory drugs, or NSAIDs, to include stronger and more specific warnings about the drugs increasing risk of heart attack and stroke.
The warning applies to drugs such as Advil, Aleve, Celebrex and other versions of ibuprofen and naproxen, but not aspirin despite it also being an NSAID.
The agency began requiring boxed warnings on prescription NSAIDS in 2005 based on evidence that stronger doses of the drugs could increase heart attack and stroke risk over time. The warnings are being adjusted now because the risk has been shown to increase even within the first few weeks of treatment.
“There is no period of use shown to be without risk,” said Judy Racoosin, M.D., M.P.H., deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products, in a press release. “Everyone may be at risk — even people without an underlying risk for cardiovascular disease.”
Prescription NSAIDs are used in treatment of osteoarthritis, rheumatoid arthritis, gout and other rheumatological and painful conditions. Over-the-counter NSAIDs are used to temporarily reduce fever and to treat most minor aches and pains, from headaches and menstrual cramps to muscle aches and strains.
Although low-dose aspirin was not included among drugs whose warnings will be strengthened, the FDA said its effects that help prevent heart attack and stroke can be decreased if taken with other NSAIDs such as ibuprofen and naproxen.
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