FDA Scrutinizes Acetaminophen's Liver Risk

Concerns over unintentional overdose hazards may change the drug's labeling.

ByABC News
June 29, 2009, 8:48 AM

June 29, 2009— -- Acetaminophen is the most commonly used painkiller in the country and the U.S. Food and Drug Administration will scrutinize its safety record today in the shadow of concerns that people taking too much of it are damaging their livers.

Research has shown that hundreds of Americans each year experience acute liver failure as a result of taking acetaminophen -- widely known under the brand name Tylenol -- and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.

Although researchers have found that the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines as a somewhat hidden ingredient means patients don't realize they are taking several drugs that all contain acetaminophen.

Moreover, combining the medication with alcoholic beverages increases the risk of liver damage.

These concerns and more will be the subject of discussion today and Tuesday at the Center for Drug Evaluation and Research Joint Meeting of the Drug Safety and Risk Management Advisory Committee, the FDA's Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee.

No matter the outcome of the meeting, however, consumers will still be able to get acetaminophen. Twenty-nine billion extended units (tablets/capsules/milliliters) of prescription and over-the-counter, acetaminophen-containing products were sold through retail and non-retail pharmacies in 2005, according to the FDA.

"It's important to say that they're not considering taking acetaminophen off the shelves," ABC News Medical Contributor Dr. Marie Savard said on "Good Morning America" this morning. "When taken in the proper dosage, this is a safe drug that's been used for more than a half century. The problem is that people often take more than the maximum dosage and that can cause serious liver damage and sometimes even death."

One of the items on the FDA's agenda, Savard said, is looking into eliminating combination drugs that contain acetaminophen to curb the incidence of accidental overdose. The agency will also be exploring the possibility of better labeling of these drugs -- including strong warnings about the risks of liver damage -- and it's considering reducing the maximum daily dosage levels for over-the-counter acetaminophen to no more than 3,250 milligrams from the current max of 4,000 milligrams per day.