FDA Issues New Warnings for Painkillers
Products Containing Acetaminophen, NSAIDs Must Warn of Liver Damage, Stomach Bleeding
WebMD News Archive
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 Matthew 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."