Safe Use of Acetaminophen - Letter to Pharmacies

November 2009

Dear Pharmacist:

This letter is intended to once again raise your awareness about the important role you can play in prevention of acetaminophen-induced hepatotoxicty. The United States Food and Drug Administration Advisory Committee recently released a recommendation regarding maximum dosage and safe use of both over-the-counter (OTC) and prescription medications containing acetaminophen. The FDA and New York State Department of Health (DOH) believe pharmacists are vital in helping prevent these types of occurrences. Pharmacists provide important information to consumers regarding the appropriate use of prescription and over-the-counter (OTC) drug products. The Department in collaboration with the Pharmacist Society of the State of New York and New York State Council of Health-System Pharmacists is enlisting pharmacist to educate their consumers on this important issue.

The danger of hepatotoxicty in association with acetaminophen use has been well recognized. Acetaminophen-induced hepatotoxicty is caused by a toxic metabolite or the parent compound and can lead to liver failure, which may result in liver transplant or death. Reasons for unintentional overdoses appear to include many factors, such as the lack of consumer understanding of potential adverse effects due to taking two different products containing acetaminophen simultaneously; failure of consumers to recognize potential harm from exceeding recommended dose; the variety of products (both OTC and prescription) which contain acetaminophen; failure of consumer to recognize the active ingredient in various OTC and prescription drug products; and prescription labels which may not clearly identify acetaminophen as one of the active ingredients or the maximum daily acetaminophen dose limit. A recent review of the New York State Department of Health's controlled substance prescription data files highlighted that about 4,000 patients had been prescribed acetaminophen/hydrocodone medications that equal or exceed acetaminophen daily doses of four (4) Grams, the daily maximum dose.

For more information, FDA scientific papers, reference materials, or product literature go to:

To order any of the reference materials, please download and complete from the web page and submit as directed.

Thank you for your continued efforts concerning this medication patient safety issue.

Sincerely,

John Morley, M.D.,
Medical Director,
Office of Health Systems Management

Jennifer Treacy, RPh.
Acting Deputy Director
Division. of Quality and Patient Safety