FDA Panel Urges Cuts in Acetaminophen Dosage

"You can go to any large box store and purchase 1,000 tab bottles of extra-strength acetaminophen; that is enough to kill 25 people," Squires said. "While education is needed, education alone often does not change behavior. When dealing with potentially lethal consequences of poor behavior, it make sense to have some limits on availability."

Acetaminophen Will Still Be Available, Useful

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" on Monday 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."

The FDA has struggled with the issue of acetaminophen's safety since at least 1977, when an agency committee suggested that labels for pain relievers contain a warning that they can damage a patient's liver.

McNeil Consumer Healthcare, a Johnson & Johnson subsidiary and the manufacturer of Tylenol, said in a statement last month that it fears recommendations made by the FDA could have the effect of steering consumers away from an appropriate and safe drug.

"While we share the FDA's mutual goal of preventing and decreasing the misuse and overdose of acetaminophen, we have concerns that some of the FDA recommendations could discourage appropriate use and are not necessary to addressing the root causes of acetaminophen overdose," the statement read.

And the Consumer Healthcare Products Association, a non-profit association representing the makers of over-the-counter medicines and nutritional supplements, cited FDA data showing that more than 80 percent of fatalities associated with over-the-counter and prescription acetaminophen products involve intentional overdoses -- in other words, suicide attempts.

Still, the hazards of acetaminophen overdose have worried many people for years.

In 2002, Dr. Peter Lurie of the consumer advocacy group Public Citizen appeared before the FDA's Nonprescription Drugs Advisory Committee to relay concerns about unintentional overdoses associated with acetaminophen. In November 2005, a study in the journal Hepatology found that the majority of acute liver failure cases in the United States were due to acetaminophen poisoning. And more recent research has suggested that these cases may be on the rise.

Panel Votes to Lower Acetaminophen Dosage

In addition to the acetaminophen vote, the panel delivered the following votes this morning:

Question 1: Do you recommend that the maximum total daily dose (4 grams/day) of acetaminophen in nonprescription single ingredient and combination products be lowered?

Vote: 21 yes (11 saying this was a high priority); 16 no

Question 2: Do you recommend that the maximum nonprescription single adult dose be limited to 650 mg?

Vote: 24 yes (12 saying this was a high priority); 13 no

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