FDA wants sterner pain reliever warnings
(Reuters)Updated: 2006-12-20 09:06
WASHINGTON - US health officials said on Tuesday they want more visible side-effect warnings on the packages of over-the-counter pain relievers such as aspirin, ibuprofen and acetaminophen.
 Bayer Aspirin pills are seen in an undated file photo. US health officials on Tuesday proposed new warnings about liver and stomach risks on the labels of over-the-counter pain relievers such as aspirin, ibuprofen and acetaminophen. [Reuters]  |
The risks have been known for years, but the US Food and Drug Administration said new warnings could raise awareness among consumers and reduce deaths and injuries.
Tens of millions of Americans take over-the-counter drugs to relieve pain every year. FDA officials said the vast majority encounter no problems if they take recommended doses.
Experts worry, however, that people do not realize the dangers of taking too much or combining the medicines with alcohol. Or they may unknowingly use more than one product that contains the same ingredient and accidentally overdose.
"Consumers have to be more cognizant of what they're taking for pain relief," said Dr. Charles Ganley, the FDA's director of nonprescription drug products.
But consumer group Public Citizen said the FDA's action was "decades late," citing FDA panels that urged new warnings for acetaminophen in 1977 and 2002.
The FDA's Ganley said the effort took time because the agency had to complete a "laborious" process of writing new rules that would apply to all over-the-counter pain relievers.
NSAIDs, or nonsteroidal anti-inflammatory drugs, include aspirin, ibuprofen,
naproxen and ketoprofen.
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