FDA Officials Urge Aleve Users To Follow Label Directions
Study On Naproxen Halted Amid Increased Heart Risks
POSTED: 8:28 am EST December 21, 2004
WASHINGTON -- The Food and Drug Administration has some new advice about a popular over-the-counter pain reliever. It comes after the National Institutes of Health halted a study that found an increase in heart attacks and strokes among participants taking naproxen, sold under the brand name Aleve.
Dr. Sandra Kweder at the FDA said patients who routinely take naproxen should follow the directions carefully, including the instruction not to take it for more than 10 days. She said patients should consult a doctor if pain continues.A statement released Monday by the FDA also advised patients not to exceed the recommended doses for naproxen -- 220 milligrams twice daily.Naproxen was approved for over-the-counter use in 1994. Kweder said the FDA doesn't expect to take any new regulatory action right away. Advertising for another popular pain reliever, Celebrex, has been halted after a study found high doses of the drug were associated with an increased heart attack risk.Although studies have linked both arthritis painkillers with an increased risk of heart attack, both are staying on the market. The acting commissioner of the Food and Drug Administration said "all regulatory options" are open, but it's too early to say what action might be taken on Celebrex and Aleve. For now, Dr. Lester Crawford told NBC on Tuesday that people taking Aleve -- an over-the-counter drug -- should strictly follow the directions on the label. People who use Celebrex should consult with their doctor about whether there's something else they might be able to take in its place. A whistleblowing FDA scientist, Dr. David Graham, also appearing on NBC, said the agency didn't conduct appropriate studies to establish that the drugs were safe. He said the agency's focus has increasingly shifted away from protecting the public. But Crawford said the FDA is "not in the pocket" of drug companies. Additional Resources:
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Surveys: Take Aleve? | Take Celebrex? Dr. Sandra Kweder at the FDA said patients who routinely take naproxen should follow the directions carefully, including the instruction not to take it for more than 10 days. She said patients should consult a doctor if pain continues.A statement released Monday by the FDA also advised patients not to exceed the recommended doses for naproxen -- 220 milligrams twice daily.Naproxen was approved for over-the-counter use in 1994. Kweder said the FDA doesn't expect to take any new regulatory action right away. Advertising for another popular pain reliever, Celebrex, has been halted after a study found high doses of the drug were associated with an increased heart attack risk.Although studies have linked both arthritis painkillers with an increased risk of heart attack, both are staying on the market. The acting commissioner of the Food and Drug Administration said "all regulatory options" are open, but it's too early to say what action might be taken on Celebrex and Aleve. For now, Dr. Lester Crawford told NBC on Tuesday that people taking Aleve -- an over-the-counter drug -- should strictly follow the directions on the label. People who use Celebrex should consult with their doctor about whether there's something else they might be able to take in its place. A whistleblowing FDA scientist, Dr. David Graham, also appearing on NBC, said the agency didn't conduct appropriate studies to establish that the drugs were safe. He said the agency's focus has increasingly shifted away from protecting the public. But Crawford said the FDA is "not in the pocket" of drug companies. Additional Resources:
Previous Stories:
- December 20, 2004: Heart Risks Also Seen In Naproxen, Health Agency Says
- December 20, 2004: Pfizer To Stop Advertising Celebrex Pain Reliever
- December 18, 2004: Consumer Group Calls For Celebrex Ban
- December 17, 2004: Expert: Celebrex Still OK For People Without Heart Problems
- October 7, 2004: Vioxx May Not Be Only Drug With Heart Risk
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