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.
Voting today 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 Tan Sheet" detailed manufacturers' objections to FDA's proposals concerning acetaminophen safety here.
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 (two 500 mg pills) 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.
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.
Additionally, in what could be a significant saving grace for industry, the panel voted 24 to 13 not to eliminate combination products that contain acetaminophen from the OTC market. Some panelists expressed opinions that specific combinations should be looked at more carefully.
However, the panel voted 20 to 17 to eliminate Rx acetaminophen combination products 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 in the U.K. were effective in reducing unintended overdoses.
In discussion after the vote, a number of panelists said the vote should not be interpreted as support for high-volume containers, such as 1,000-tablet offerings.
(For more news from "The Tan Sheet" click here for a free trial or kick off your subscription today.)
-- Christopher Walker (c.walker@elsevier.com)
