MAY 01, 2007

Sen Chuck Grassley's (R, Iowa) recent letter to the FDA urged the agency to undertake an educational campaign to better inform the public about acetaminophen safety. He said he is making an appeal to the FDA because the agency waited 4 years after receiving a recommendation from one of its own advisory committees that it needed to take action to reduce accidental acetaminophen overdose.

The agency proposed a rule on December 19, 2006, to amend the labeling regulations on OTC pain relievers, particularly acetaminophen and nonsteroidal antiinflammatory drugs (NSAIDs), that would strengthen the warnings on acetaminophen products and implement other public safety measures. The new labeling will be required for both single- ingredient and multiingredient OTC drugs containing the pain relievers.

In his letter, Grassley stated, "I also recognize that the FDA's regulatory action to date involves only a proposed rule, such that no implementation of any proposed safety measures has yet occurred."

For acetaminophen, the FDA has suggested removing the warning against taking the pain reliever along with alcohol. The agency has incorporated that message into an enhanced warning cautioning patients against possible liver damage if they take more than the recommended dose in a 14-hour period or if they consume ≥3 alcoholic beverages while taking the drug.

For NSAIDs, the new warnings underscore the potential for stomach bleeding in patients who are over age 60 or who have had prior ulcers or bleeding, take a blood thinner, are taking >1 product containing an NSAID, are taking it for a longer time than directed, or are consuming moderate amounts of alcohol while taking the drug.