NEWS - FDA issues new warnings for painkillers

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FDA Issues New Warnings for Painkillers

Products Containing Acetaminophen, NSAIDs Must Warn of Liver Damage,

Stomach Bleeding

By Bill Hendrick

WebMD Health News

Reviewed by Louise Chang, MD

April 28, 2009 -- The FDA has implemented new rules requiring stronger

and more extensive label warnings about the risk of liver damage and

stomach bleeding for people taking common over-the-counter pain

relievers.

The FDA's Ray Holman, PhD, says the new warnings are necessary

" to raise consumer awareness about the potential for liver damage when

using acetaminophen (such as Tylenol) and the potential for stomach

bleeding when using [a nonsteroidal anti-inflammatory drug], " commonly

called an NSAID. NSAIDs include aspirin, ibuprofen, naproxen, and

ketoprofen.

Holman says within a year over-the counter- medications containing

acetaminophen or NSAIDs must carry bolder warnings about risks such as

stomach bleeding and liver damage.

" The regulations affect much of the U.S. population because

over-the-counter pain relievers and fever reducers are some of the

most commonly used drugs, " he said during a teleconference.

For products containing acetaminophen, labels must bear the

medication's name " prominently " and in highlighted text on the front,

says Holman, deputy director of the FDA's Division of Nonprescription

Regulation Development.

Plus, acetaminophen products must explain in the warnings section that

" severe liver damage may occur if you take more than the maximum

number of daily dosage units in 24 hours, if you take with other drugs

containing acetaminophen, and if you take three or more alcoholic

drinks every day while using this product. "

Because so many over-the-counter and prescription medications contain

acetaminophen, the FDA says it is also requiring this warning: " Do not

use with any other drug containing acetaminophen, prescription or

nonprescription. If you are not sure whether a drug contains

acetaminophen, ask a doctor or pharmacist. "

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Read the full article here:

http://www.webmd.com/pain-management/news/20090428/fda-issues-new-warnings-paink\

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