Acetaminophen can cause liver damage

With the risk of liver damage from acetaminophen overdoses, an advisory committee to the FDA is recommending stronger warning labels for the medication and changes in dosage limits.

Acetaminophen-related liver injury was the “leading cause of acute liver failure,” according to the committee report, from the years 1998 through 2003. Severe cases of acetaminophen-toxicity can cause death.

It doesn’t take much to cause a lot of damage, says the report.

“Taking just small amounts of acetaminophen over the recommended total daily dose (four grams per day) may lead to liver injury,” stated the report. “Currently recommended doses and tablet strengths of acetaminophen leave little room for error and the onset of liver injury can be hard to recognize.”

Research showed that many people take more than the recommended amounts and others unknowingly take multiple products containing acetaminophen at the same time.

“There is extensive evidence that hepatoxicity (liver toxicity) caused by acetaminophen use may result from lack of consumer awareness that acetaminophen can cause severe liver injury,” states the report. Finding ways to educate the public about the problem has been difficult, they stated.

Attempts by the Food and Drug Administration to educate the public about the medication’s potential problems have been on-going since the 1990s when research showed it was a major cause of liver failure. Those attempts have been fraught with problems, from budgetary restraints to reluctance by stores to post FDA-issued warnings.

Compounding the problem of public education about acetaminophen’s risks is diagnosis of liver toxicity. The onset of symptoms from liver injury can take days to be present, even in severe cases. Because they can be non-specific and mimic flu-like symptoms, they can also be hard to identify.

Tylenol is the most widely-known over-the-counter brand of acetaminophen, while prescription products include Vicodin and Percocet.

The committee recommends limiting the adult daily dose to no more than 3,250 milligrams. Lower dosages will be recommended for those who consume three or more alcoholic drinks per day. Tablet strengths are also urged to be lowered on immediate-release formulas.

A joint meeting of three different FDA advisory committees to discuss recommended changes is to be held June 29 to 30 in Adelphi, Maryland.

(By Sheilah Downey, and edited by Heather Kelley)