Pharmacy Times, Volume 0, 0

Sen Chuck Grassley's (R,Iowa) recent letter to theFDA urged the agency toundertake an educationalcampaign to better informthe public about acetaminophensafety. He said he ismaking an appeal to theFDA because the agencywaited 4 years after receivinga recommendationfrom one of its own advisorycommittees that it neededto take action to reduceaccidental acetaminophenoverdose.

The agency proposed arule on December 19, 2006,to amend the labeling regulationson OTC pain relievers,particularly acetaminophenand nonsteroidal antiinflammatorydrugs (NSAIDs),that would strengthen thewarnings on acetaminophenproducts and implementother public safetymeasures. The new labelingwill be required for both single-ingredient and multiingredientOTC drugs containingthe pain relievers.

In his letter, Grassley stated,"I also recognize thatthe FDA's regulatory actionto date involves only a proposedrule, such that noimplementation of any proposedsafety measures hasyet occurred."

For acetaminophen, theFDA has suggested removingthe warning againsttaking the pain relieveralong with alcohol. Theagency has incorporatedthat message into anenhanced warning cautioningpatients against possibleliver damage if they takemore than the recommendeddose in a 14-hour periodor if they consume ≥3 alcoholicbeverages while takingthe drug.

For NSAIDs, the newwarnings underscore thepotential for stomach bleedingin patients who are overage 60 or who have hadprior ulcers or bleeding,take a blood thinner, aretaking >1 product containingan NSAID, are taking itfor a longer time thandirected, or are consumingmoderate amounts of alcoholwhile taking the drug.