PPSI to FDA: Regulate Acetaminophen Labeling

By Levy, Sandra | Drug Topics, November 2, 2006 | Go to article overview

PPSI to FDA: Regulate Acetaminophen Labeling


Levy, Sandra, Drug Topics


Pharmacists Planning Service Inc. (PPSI) has submitted a citizen's petition to the Food & Drug Administration to regulate the labeling and packaging of acetaminophen/APAP-containing products so that the label states, "Contains acetaminophen. Do not take with any other acetaminophen/ APAP." PPSI is also asking that no more than 50 tablets be sold in a bottle and that the FDA mandate a MedGuide.

"Most people don't know Tylenol is acetaminophen, and they certainly don't know that APAP (the abbreviation for acetaminophen) is in Vicodin and other products," explained Fred Mayer, R.Ph., president of PPSI. Pointing out that in England acetaminophen can only be sold behind the pharmacy counter, Mayer said the maximum the pharmacist can sell is up to 32 tablets. "We're asking for up to 50 as the maximum quantity that can be sold."

Maurizio Bonacini, M.D., transplant hepatologist at the California Pacific Medical Center, San Francisco, who signed the petition, told Drug Topics, "There are data showing that acetaminophen is the No. 1 cause of liver failure."

Bonacini referred to a study published in the July 5 issue of the Journal of the American Medical Association (JAMA) that showed an association between the dosage of 4 gm a day of acetaminophen and elevated alanine aminotransferase (ALT) levels.

What does the pharmacy community think about this petition? Matthew Seamon, Pharm.D., assistant professor at Nova Southeastern University College of Pharmacy, Ft. Lauderdale, Fla., thinks consumers should be made more aware of the risks of taking cough and cold medications at the same time as pain medications that contain acetaminophen.

Seamon said he would not like to see pregnant women's access to acetaminophen limited, because they might take a nonsteroidal anti-inflammatory drug (NSAID) instead. "That is probably less safe for a pregnant woman," he asserted.

Janet Engle, Pharm.D., associate dean for academic affairs and clinical professor of pharmacy practice at the University of Illinois at Chicago College of Pharmacy, pointed out that acetaminophen dosing information for children under the age of two is needed. …

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