Tylenol Overdose Risk Results in Lowering Maximum Dose

Johnson & Johnson’s McNeil Consumer Healthcare division has announced that it is lowering the maximum recommended dosage on Tylenol and other products containing acetaminophen, in an attempt to reduce the risk of acetaminophen overdoses that could result in liver damage. 

The new Extra Strength Tylenol recommended maximum daily dosage will drop from 4,000 mg per day to 3,000 mg per day, dropping the maximum recommended dose from eight pills to six pills.

In a press release issued Thursday announcing the changes, McNeil also said it will change the labels on all of its other acetaminophen-containing products to help reduce the risk of Tylenol liver damage.

The label changes will show up on packaging this fall and next year.

The decision comes as the FDA has struggled to determine what to do about the growing problem of acetaminophen overdoses and liver damage due to the ubiquitous presence of the drug in a variety of painkillers and cold medicines. In January, the FDA announced new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet. But over-the-counter painkillers and drugs with acetaminophen went unaffected. 

Acetaminophen is the main ingredient in Tylenol and used in many cold medicines, but it is also often combined with powerful painkillers. Drugs affected by the limits put into effect in January included Vicodin (acetaminophen and hydrocodone), Percocet (acetaminophen and oxycodone), and Tylenol with Codeine (acetaminophen and codeine).

According to the FDA, most of the reports of sever liver injury involved cases where consumers took more than the prescribed dose within a 24-hour period, took more than one product containing acetaminophen at the same time or drank alcohol while taking acetaminophen.

A year ago, an FDA advisory panel said users of medications that combine acetaminophen with narcotics increase the danger of liver damage and overdose because patients who take the drugs for long periods often need higher and higher doses to achieve the same effect. This means that their livers are receiving higher and higher doses of acetaminophen.

More than 400 people per year die, and 42,000 are hospitalized, from overdoses due to drugs that use acetaminophen.