FDA panel calls for crackdown on acetaminophen

The dangers of the painkiller acetaminophen, which include liver damage and death from overdosing, have long been a concern, and Tuesday, a Food and Drug Administration advisory committee recommended the agency take strong action to protect the public, including banning widely used prescription pain drugs, such as Percocet and Vicodin, that combine acetaminophen with a narcotic opioid.

Acetaminophen is hard to avoid because it’s in so many products, from Percocet and Vicodin to hundreds of over-the-counter medicines, such as cough syrups and the pain relievers Excedrin and Tylenol. And that makes it dangerous, because people who are taking a few of these drugs at the same time can unwittingly take too much acetaminophen, which can lead to liver damage and even death.

Among the advisory panel’s other recommendations were that the highest allowed dose of acetaminophen in over-the-counter pills be reduced from its current level of 500 mg to 325 mg and that the maximum daily dosage be dropped to less than 4,000 mg. The panel also recommended that acetaminophen products contain a black box warning about the risk of liver damage, the most serious warning the FDA bestows.

The FDA is not bound by its advisory committee’s recommendations, but it often follows their advice. While the agency is considering how it will respond, our medical advisors remind you to follow directions on acetaminophen (and all drug) labels. Don't exceed the labeled maximum dosage, avoid acetaminophen if you drink heavily or have liver disease, and don't use more than one acetaminophen product at a time.

Be aware that many combination products—especially those sold for coughs, colds, and flu—may contain acetaminophen, so be sure to always read the label.

—Steve Mitchell, associate editor, Best Buy Drugs

Read more on how to take acetaminophen, watch our video on overusing OTC painkillers (above), and if you have concerns about your medications, take a look at some questions to ask your pharmacist. You can also read our coverage of recommendations in May from an FDA working group to improve the safety of acetaminophen-containing products.