FDA Proposal Would Limit Acetaminophen Doses

July 10, 2009

A proposal that would limit the maximum over-the-counter dose of Tylenol and ban the narcotic painkillers Vicodin and Percocet is currently under consideration by the Food and Drug Administration.

A proposal that would limit the maximum over-the-counter dose of Tylenol and ban the narcotic painkillers Vicodin and Percocet is currently under consideration by the Food and Drug Administration (FDA).

The announcement of the proposal on June 30th by the FDA was initiated by concerns about acetaminophen overdoses, the leading cause of liver failure. More than 50,000 people overdose and at least 200 people die each year in the US.

The FDA’s proposal would make the current single maximum Tylenol dose of 1,000 milligrams available to patients by prescription only, and the new maximum single dose would be lowered to 650 milligrams. The current daily limit on Tylenol is 4 grams, or about 12 regular-strength Tylenol pills, which would also be lowered, though a specific amount was not provided.

In addition to the dosage changes for Tylenol and the bans on Vicodin and Percocet, the FDA proposal also calls for a pamphlet to be sold with propoxyphene that details the risk involved in taking the drug.

According to the AP report, liver problems associated with use of Tylenol and other forms of acetaminophen occur suddenly. Symptoms usually occur within three days of taking extra doses, said Dr. William M. Lee, a liver disease specialist at the University of Texas Southwestern Medical Center () in Dallas, and even a few extra pills taken over the course of several days can lead to problems.

The proposal led several physicians to speak out against the suggested restrictions. Dr. Gil Fanciullo, of the American Pain Society (http://www.ampainsoc.org/), said that the restrictions may lead to the under-treatment of pain, as well as the prescribing of stronger narcotics to patients. In addition, Fanciullo said that the restriction would seriously limit the options that patients with severe pain have.

"If these drugs were not available to our patients, there would be a stampede toward the doctor to try to figure out an alternative treatment for them because they're such widely used drugs," said Fanciullo, who is also a pain management specialist at Dartmouth-Hitchcock Medical Center (http://www.dhmc.org/) in Lebanon, NH.

For more information on the FDA proposal and acetaminophen, click here.