National Consumers League

Common Pain Relievers Under Scrutiny


By Rebecca Burkholder, NCL Vice President for Health Policy Americans love our pain relievers, but health advocates are increasingly concerned that they can be dangerous to our health if not taken safely. Last week a FDA Advisory Committee recommended to lower the maximum does of acetaminophen, a key ingredient in many over-the-counter (OTC) pain relievers (like Tylenol and many generic versions, like the ones sold at CVS, Target, and other pharmacies), and to ban prescription drugs that combine acetaminophen with other drugs. I attended the FDA hearing to give NCL’s view on consumer acetaminophen and hear what the experts are saying about the danger of too much acetaminophen. High doses of acetaminophen are the leading causes of liver injury in the United States. More that 400 people die and 56,000 visit the emergency room every year in the United States due to acetaminophen overdoses. Consumers don’t know that acetaminophen is an active ingredient in many OTC products, or that it is dangerous to take too much acetaminophen. In fact, almost half of all adults are not sure of the main active ingredient in the OTC pain medication they take most often, and two-thirds of consumers who use OTC acetaminophen are not concerned about overdoses, according to the preliminary results of a new NCL survey of consumer use and attitude towards pain relievers. To prevent some of these accidental overdoses, the FDA Advisory Committee is recommending that the federal health agency reduce the maximum single adult dose of OTC acetaminophen from 1,000 mg (two 500 mg strength tablets) to 650 mg (two 325 mg strength tablets). The Committee also discussed the dangers of combination prescription pain relievers that contain acetaminophen, as well as other drugs – over long periods of time, many consumers take more to relieve their pain and they mistakenly take with other medications also containing acetaminophen. The Committee voted to ban these combination prescription drugs containing acetaminophen (such as Percocet and Vicoden – two of the most popular pain relievers). The FDA is not required to follow the recommendations of the Advisory Committee, but it often does. NCL shared with the Committee the preliminary results of our recent survey on acetaminophen and emphasized the need to remind consumers that just because a drug is available at their local drug store or supermarket, does not mean it is risk-free. We also announced that we will be launching a public education campaign to help consumers understand how to use acetaminophen – with a special focus on teens and Hispanics. Next time you reach for a pill to relieve your pain – remember to take it safely.