Tylenol Dose Lowering: A Long Time Coming?

In February of 2008, the Acetaminophen Hepatotoxicity Working Group put together a 250 + page document containing valuable recommendations for the FDA to limit the number of cases of acetaminophen toxicity ^[1]. The document, Recommendations for FDA Interventions to Decrease the Occurrence of Acetaminophen Hepatotoxicity, included an in-depth discussion on multiple ways the FDA can accomplish this including; enhance patient education, improve labeling, limit the maximum adult daily dose, limit tablet strength, limit options in pediatric formulas, eliminate combination products, and identify any further research needs ^[1].

The misunderstanding and misuse of over the counter (OTC) medications contributes to Tylenol being the top cause of liver failure. In 2003, 49% of acute liver failure (ALF) cases were acetaminophen-associated ^[2]. It is difficult for consumers to simply follow the instructions on the label due to the availability of over 600 OTC and prescription medications containing the active ingredient, acetaminophen ^[3].

A press release from McNeil Consumer Healthcare stated that in order to encourage appropriate use of acetaminophen and avoid overdose they are lowering the maximum daily dose of single ingredient Extra Strength Tylenol products. The new recommendation of 3000 mg per day or 6 tablets is a 25% decrease from the original 4000 mg, 8 tablets maximum per day. New dosing instructions will appear on labels this fall ^[4].

McNeil is also heightening awareness regarding label changes by including bottle cap messages which will remind patients to always read and follow label instructions ^[4]. Why have the makers of Tylenol only lowered the maximum daily dose of one product? It seems as this is just the beginning. McNeil will be lowering the maximum dosage of Regular Strength Tylenol and other adult acetaminophen containing products starting in 2012 ^[4].

To aid in public awareness the makers of Tylenol have created an interactive website which helps patients identify medications that have acetaminophen in them. This website is titled: get relief responsibly (www.tylenol.com/getreliefresponsibly) ^[5].

1. The Acetaminophen Hepatotoxicity Working Group. "Recommendations for FDA Interventions to Decrease the Occurrence of Acetaminophen Hepatotoxicity." Letter to Janet Woodcock, M.D. 26 Feb. 2008. FDA. US Department of Health and Human Services. Web. 12 Aug. 2011. <http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164898.pdf>.
2. Lee, W. M. "Minophen and the U.S. Acute Liver Failure Study Group: Lowering the Risks of Hepatic Failure." Hepatology 40.1 (2004): 6-9. PubMed. Web. 19 Aug. 2011. <http://www.ncbi.nlm.nih.gov/pubmed?term=Lee%2C%20W.%20M.%20(2004)%2C%20Acetaminophen%20and%20the%20U.S.%20acute%20liver%20failure%20study%20group%3A%20Lowering%20the%20risks%20of%20hepatic%20failure.%20Hepatology%2C%2040%3A%206%E2%80%939.%20doi%3A%2010.100>.
3. "Acetaminophen: MedlinePlus Drug Information." National Library of Medicine - National Institutes of Health. National Institute of Health, 16 Mar. 2011. Web. 19 Aug. 2011. <http://www.nlm.nih.gov/medlineplus/druginfo/meds/a681004.html>.
4. Johnson & Johnson. McNeil Consumer Healthcare Division. McNeil Consumer Healthcare Announces Plans For New Dosing Instructions For Tylenol® Products. 28 July 2011. Web. 19 Aug. 2011. <http://www.jnj.com/connect/news/all/Mcneil-Consumer-Healthcare-Announces-Plans-For-New-Dosing-Instructions-For-Tylenol-Products>.
5. Get Relief Responsibly™ Sponsored by TYLENOL® - Medicines That Contain Acetaminophen." TYLENOL® - The Official Website for All TYLENOL® Products. Web. 19 Aug. 2011. <http://www.tylenol.com/getreliefresponsibly/index.jhtml?id=tylenol/getreliefresponsibly/contain_aceta.inc>.