Advocates Ask FDA To Tighten Rules For Acetaminophen Labeling, Marketing
This article was originally published in The Tan Sheet
Executive Summary
Advocates for tighter labeling rules for non-aspirin OTC acetaminophen products point to the approaching holiday season and the attendant increase in alcohol use as they ask FDA to act on their petition for regulatory action
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Advocates for tighter labeling rules for non-aspirin OTC acetaminophen products point to the approaching holiday season and the attendant increase in alcohol use as they ask FDA to act on their petition for regulatory action. "With the amount of alcohol we consume in this country, mixing [acetaminophen-based OTCs] with alcohol is a disaster waiting to happen," says Frederick Mayer, RPh, a San Rafael, Calif. pharmacist and president of the Pharmacists Planning Service. Mayer and other advocates and researchers filed a citizens petition asking FDA to mandate that all non-aspirin containing OTC medicines with acetaminophen be "clearly labeled 'Contains acetaminophen. Do not take with any other acetaminophen.'" Mayer and his associates in the petition - including transplant surgeons who frequently treat patients with liver damage from excessive acetaminophen use - also ask FDA to limit packages of acetaminophen products, recommending no more than 32-count packages for 500 mg tablets or capsules and requiring blister packs. FDA also should require acetaminophen packages to include a guide detailing recommended dosages and possible adverse drug events of acetaminophen products, "including increased risks with chronic alcohol consumption," the petition says. "We want it behind the counter like [OTC pseudoephedrine products]," Mayer said. Research cited in the petition shows the leading cause of liver damage is over-use of McNeil's Tylenol acetaminophen analgesic. A JAMA study linking acetaminophen intake at OTC doses to increased liver toxicity prompted the American Liver Foundation to warn consumers not to exceed intake of 3 grams of the drug a day for any prolonged period of time (1 (Also see "American Liver Foundation Issues Warning On Acetaminophen Intake Levels" - Pink Sheet, 24 Jul, 2006.), p. 7). Mayer says he and his associates do not expect FDA to adopt new rules for acetaminophen labeling this year, but expect the agency to act on their petition. "They must educate the public, which they're not doing," he said. - Malcolm Spicer |