Pain relievers label final rule not ready
This article was originally published in The Tan Sheet
Executive Summary
FDA says it "inadvertently, mistakenly posted" a Jan. 23 pre-publication notice indicating that a final rule for OTC internal analgesic product labels would be published in the Jan. 26 Federal Register. The rule would amend labels for non-steroidal anti-inflammatory drugs and acetaminophen-containing products to include warnings of gastrointestinal and liver injuries associated with improper use (1"The Tan Sheet" Jan. 26, 2009, In Brief). FDA announced the posting error Jan. 26, but did not say when the rule will be published