FDA Asks Companies for Pain Reliever Warning


FDA issued a ruling that requires manufacturers of over- the-counter pain relievers to include warnings of health risks on their labels.

The recent ruling requires the makers of Tylenol, Motrin, Advil and Aleve to include more specific, standardized and prominent warnings on their products. Products, like Tylenol, which contain acetaminophen are required to include warnings of liver toxicity, particularly when used in high doses, with other acetaminophen products or with three or more drinks of alcohol a day. Products containing NSAIDs (non-steroidal anti-inflammatory drugs), such as ibuprofen, are required to carry a warning about stomach bleeding in people over 60, those who have had ulcers, take a blood thinner or more than one NSAID, those who take them with alcohol or longer than directed. NSAIDs work by blocking the production of prostaglandins, which are hormone-like substances that contribute to arthritis pain and inflammation. Prostaglandins have beneficial functions in the body, including protecting the stomach lining and helping to maintain kidney function. By blocking these actions, along with the inflammatory ones, NSAIDs can lead to an upset stomach, peptic ulcers or interfere with kidney function. New labels will likely not be required for at least another year.

Created on January 1, 2003

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