FDA Recommends Acetaminophen Warnings to Lower Liver Injury Risk

When a headache rears its head, the first thing many people reach for is acetaminophen.

A second thought might be warranted.

The Food and Drug Administration is recommending stronger warnings and dose limitations on the painkiller to decrease risk for liver injury, according to a report released Wednesday. Acetaminophen, a pain and fever reducer, is sold as Tylenol and in other medications.

Unintentional overdose of acetominophen has been known to cause liver injury since the late 1990s, according to the report. Despite the agency's efforts to educate consumers, the drug remains a leading cause of acute liver failure in the U.S. The report also noted acetaminophen overdose as being linked to 458 deaths and 26,000 hospitalizations each year.

The hope is that stronger warnings will help curb these overdose numbers.

"It is important...to initiate measures that could to the extent possible decrease the number of unintentional overdose cases," the report said.

One cause of overdose is the use of multiple drugs that may contain acetaminophen.

"Consumers may not be aware that acetaminophen is present in many over-the-counter combination products, so they may unknowingly exceed the recommended acetaminophen dose if they take more than one acetaminophen product without knowing that both contain acetaminophen," the report said.

Members of the FDA drug safety, anesthetic and life-support drugs, and nonprescription drug advisory panels will meet June 29-30 to discuss recommendations for acetaminophen products.

The working group listed seven recommendations for over-the-counter (OTC) products containing acetominophen:

1. Education: Increase FDA efforts to educate consumers and health care professionals about acetaminophen hepatotoxicity.

2. Enhanced labeling: Listing acetaminophen prominently on the display panel and including various warnings.

3. A change in the maximum adult daily dose: Reduce the recommended adult maximum daily dose from 4 grams per day to 3250 milligrams.

4. A change in tablet strength and recommended single adult dose: Reduce tablet strength for immediate-release formulations to 325 mg and limit the single adult dose to 650 mg.

5. A change in the permitted liquid formulations: limit pediatric liquid acetaminophen medicines to one concentration and require that a measuring device be included in each package.

6. Elimination of OTC combination products: eliminate acetaminophen from all OTC combination medications.

7. Additional research: Identify currently existing research or consider conducting further research to address important issues that do not appear to have been adequately addressed.

These recommendations will be discussed at the meeting in Adelphi, Maryland at the end of June.

Source: FDA report