Calls for warnings on painkillers

Concerned that consumers may not fully understand the risks associated with common painkillers, a Food and Drug Administration panel has recommended more explicit warnings on package labels of products containing aspirin, ibuprofen, and acetaminophen.

Certain groups of patients, including the elderly, need to know they risk kidney failure or stomach bleeding from a class of drugs known as nonsteroidal anti-inflammatory drugs or NSAIDs. This class includes aspirin, ibuprofen (found in Motrin and Advil), and naproxen (found in Aleve).

The panel also voted 21-1 to urge stronger warnings on labels of products containing acetaminophen, the main ingredient in more than 200 over-the-counter cold and headache remedies, including Tylenol. It also is found in prescription painkillers, including Percocet and Vicodin. The panel cited evidence that 100 Americans die and another 2ꯠ are hospitalized with liver damage caused by unintentional overdoses of acetaminophen.

The panel called for packages to state in bold type that the product contains acetaminophen and that taking more than the recommended dose could cause liver damage. Also, package warnings should caution consumers not to take more than one product containing acetaminophen at the same time.

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