FDA Panel Supports Lower Acetaminophen Dose But Spares Combo Products

In what could be a major blow to manufacturers, acetaminophen sold in 500 mg tablets will come off the OTC market if FDA follows a joint advisory committee's recommendations, but the industry may be spared the additional pain of losing combination products that include acetaminophen and other ingredients.

In what could be a major blow to manufacturers, acetaminophen sold in 500 mg tablets, such as Tylenol Extra Strength, will come off the OTC market if FDA follows a joint advisory committee's recommendations.

In voting June 30 on a number of potential regulatory and risk-mitigating actions, panelists with expertise in nonprescription and anesthetic drugs and drug safety and risk management also overwhelmingly supported limiting liquid acetaminophen products to a single concentration, with only one member opposing and 19 ranking it a high priority.

However, the industry may be spared the additional pain of losing combination products that include acetaminophen and other ingredients, such as many cold and flu products.

The panel voted 24 to 13 to lower the maximum adult single dose of acetaminophen from 1,000 mg (two 500 mg tablets) to 650 mg, essentially favoring eliminating 500 mg tablets from the OTC market. Half of the yea voters favored ranking the action as a high priority, which FDA said the panel members could indicate in their votes.

They voted 26 to 11 to make the 1,000 mg dose available by prescription.

In its briefing documents, FDA said 500 mg products made up 92 percent of U.S. sales of single-ingredient acetaminophen in 2005, citing IMS Health data.

Additionally, in a related vote, 21 panelists supported lowering the daily maximum dose from 4 g, versus 16 against. Eleven yeas ranked this measure a high priority.

A split vote not to remove OTC combination products from the market may spare the industry the pain of losing combination products, which made up roughly 80 percent of the $2.6 billion of acetaminophen sales in 2008, including many cold and flu products.

However, the panel's 24-to-13 vote and its deliberations reflected "uncertainty" about whether OTC combinations should remain on the shelf, said Sandra Kweder, deputy director of FDA's Office of New Drugs.

Some panelists also opined during the meeting that specific combinations should be looked at more carefully.

However, the panel voted 20 to 17 to eliminate Rx acetaminophen combination products - such as Vicodin and Percocet - to reduce hepatotoxicity risk. Of the 20 who voted for the change, 10 ranked it a high priority.

The panelists did not endorse limiting package sizes, with 20 no votes and 17 in favor. Generally panelists were not convinced that similar limits imposed in the U.K. were effective in reducing unintended overdoses.

In discussion after the vote, a number of panelists said the vote on package sizes should not be interpreted as support for high-volume containers, such as 1,000-tablet offerings.

Following the meeting, Consumer Healthcare Products Association President Linda Suydam said the trade group was "disappointed" in the vote to lower the maximum daily dose and single dose of acetaminophen.

She said there was "a notable lack of data referenced by the committee to support these recommendations and overwhelmingly strong data affirming the efficacy and safety of acetaminophen in its current dosage forms."

-Christopher Walker ([email protected]) and Elizabeth Crawford ([email protected])

[Editor's note: This story appears courtesy of the editorial staff of ¹ 'The Tan Sheet,' your source for coverage of nonprescription pharmaceuticals and nutritionals. For a sample copy, call customer service at 800-332-2181.]