Acetaminophen and Liver Injury

Three FDA advisory committees are meeting today to discuss possible ways to try to cut the risk of liver injury from acetaminophen in over-the-counter and prescription products.

You might not know "acetaminophen," because that's the drug's generic name. It's found in many over-the-counter products -- including Tylenol, aspirin-free Anacin, Excedrin, and numerous cold medicines. It's also found in many prescription drugs.

The FDA says acetaminophen is generally considered safe when taken according to the directions on product labels. But taking too much acetaminophen -- even a little too much taken by accident -- can lead to liver injury.

Products containing acetaminophen already note that risk. But today's FDA meeting is happening because some people still take too much acetaminophen.

Today, the three FDA advisory committees will vote on various options, ranging from additional warnings to limiting doses to banning over-the-counter acetaminophen products. The FDA isn't required to follow the advice of its advisory committees.

Makers of acetaminophen products and the Consumer Healthcare Products Association (CHPA), a trade group for the over-the-counter drug industry, have stressed the safety of acetaminophen when used properly and argued for keeping the products on the market, according to media reports.

As the FDA advisory committees weigh their options, here are steps the FDA wants people to take when using acetaminophen to reduce the chance of liver injury:

• Follow dosing directions and never take more than the recommended dose of acetaminophen.
• Do not mix acetaminophen-containing products. For instance, acetaminophen could be in a headache medicine and in a cold medicine; if you take both, you may wind up getting too much acetaminophen.
• Talk to your doctor about acetaminophen if you drink alcohol or have liver disease.
• Be aware that acetaminophen comes in many forms, including drops, syrups, capsules, and pills.
• Check drug labels to see if it contains acetaminophen. If you're taking a nonprescription (over-the-counter) product, check the "Active Ingredients" section of the "Drug Facts" label.
• Know that acetaminophen may be abbreviated as "APAP" on prescription drug labels.
• Don't take acetaminophen for more days than directed.

The FDA notes that acetaminophen can be given to infants, children, and teens, but the FDA reminds parents and caregivers to take these steps, posted on the FDA's web site, for safety's sake:

• Check the active ingredients list on drug labels. Your child should never take more than one medicine containing acetaminophen, whether it's an over-the-counter drug or a prescription drug.
• Read and follow all the directions given by your child's doctor and on product labels.
• Choose the right medicine based on the child's weight and age. Check the "Directions" section of the "Drug Facts" label on over-the-counter products to see if the medicine is right for your child, how much medicine to give, how many hours to wait before giving another dose, and when to stop giving acetaminophen and ask a doctor for help.
• Use measuring tools that come with the medicine. Don't use a spoon that's meant to be used for cooking or eating. If you don't have the measuring tool that came with the medicine, ask your pharmacist for one.
• Keep a record of what doses you gave the child and when.
• Keep all medicines where they can't be seen or reached by children -- a locked box, cabinet, or closet is best.

If you or someone else takes too much acetaminophen, the FDA recommends calling 911 or Poison Control (800-222-1222) right away to find out what to do. Liver injury symptoms may not appear for hours or even days -- and by then, the damage may be severe and could lead to death.

Of course, any medication should be taken as directed. That includes other types of pain relievers besides acetaminophen. For more FDA tips on pain medicines, read A Guide to Safe Use of Pain Medicine.

And tell us, how careful are you when you take acetaminophen? How strictly do you follow the directions on the label -- even when you're, say, hung over or feeling sick?