FDA wants new labels on acetaminophen

You may already be aware that the widely-used painkiller acetaminophen (Tylenol or generic) can cause liver damage that may lead to liver failure, if you take more than the recommended dose. Despite steps by the FDA from the last decade to warn consumers of the risks, recent studies indicate that overdosing leading to liver damage continues to occur. In response, the FDA working group is now recommending* several safety measures–mostly to changes on the label–that amount to prominently displaying that an over-the-counter drug contains acetaminophen and to warn people about the risk of severe liver damage. The FDA also wants manufacturers to reduce the maximum adult and child doses to avoid an overdose.

While these changes from the FDA may take months or longer to appear on your drugstore shelves, in the meantime, we think it is worth a reminder to:

• Carefully read the list of active ingredients that is on the package and label of any over-the-counter drugs you take, and be aware that acetaminophen is a common drug that appears in many combination products. Avoid doubling up on combination products as well.
• Don’t exceed the maximum dosage. Recognize that even doubling the maximum allowable dose for an adult for a few days can be toxic and even deadly.
• Avoid acetaminophen if you are a heavy drinker.

Acetaminophen is an effective drug for reducing fever and treating many types of pain—and is also widely used. In a recent Consumer Reports National Research Center survey, 73 percent of respondents stocked their medicine cabinets with the drug. And because of its popularity, we’ve have warned consumers about the harms of taking more than the recommended dose of acetaminophen, particularly in the case of combination products. And while many people consume extra acetaminophen unknowingly, others disregard the labeling. In our survey, only 69 percent of respondents said they always or nearly always carefully follow instructions on the label. And 5 percent used OTC pain relievers daily for two weeks or more without a health expert's approval, contrary to directions on the label.

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.

We'll be sure to post an update after the group's meeting in late June.

—Ginger Skinner

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.

*links to PDF

Comments

[Ben]

I think more people need to take a bigger picture approach to this latest FDA news. Who is the FDA ultimately protecting? How long do they wait, how many lives are affected before they take this kind of action on big pharma drugs? Too long. How long do they wait to come down hard on the natural health industry when a few people lose their sense of smell (for example)? Not that long. The makers of Zicam got dragged through the media a few weeks ago after 100 or so people lost their sense of smell temporarily over a ten year period, but it takes 20 years or so for the FDA to say anything about the drug that is the leading cause of liver failure in the U.S. What's the problem here? The FDA Investigates Acetaminophen Safety - Swanson Vitamins Blog

[Capri]

They need to make the regular strength APAP more readily available as it is all Extra Strength 500 mg now instead of the 325 mg dose. I can hardly find it anymore at the store.