FDA calls for new warnings on anti-inflammatory drug labels

BETHESDA, Md. The Food and Drug Administration on Friday issued a final rule to require important new organ-specific warnings and related labeling for over-the-counter acetaminophen and other nonsteroidal anti-inflammatory drugs, to be published in the Federal Register Jan. 26.

The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using NSAIDs and applies to both medicines marketed under monograph, as well as those approved through a new drug application.

The rule will become effective Jan. 26, 2010, including products with annual sales less than $25,000.