Acetaminophen and Acetaminophen Combination Products  7/2/2009

      A panel from the FDA has recently issued a statement that may result in the ban of combination products that contain Acetaminophen, better known as Tylenol. These commonly prescribed drugs also known by the trade names, Vicodin, Lortab, Percocet and Tylox.

The following is from the FDA briefing:

      Acetaminophen is one of the most commonly used drugs in the United States for treating pain and fever—in 2005, consumers purchased more than 28 billion doses of products containing acetaminophen, and the hydrocodone–acetaminophen combination product has been the most frequently prescribed drug since 1997. However, exceeding the maximum recommended dose of acetaminophen (4 grams per day) can cause serious liver injury—even death. Despite a number of efforts since the early 1990s to reduce the incidence of acetaminophen-related liver injury, the extent of liver failure cases reported in the medical literature indicates that liver injury from acetaminophen overdose remains a serious public health problem. This problem will be discussed at a joint meeting of the Drug Safety and Risk Management Advisory Committee, the Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee on June 29 and 30, 2009.

Liver Injury, Population Overall
       From 1998 to 2003, acetaminophen was the leading cause of acute liver failure in the United States, with 48% of acetaminophen-related cases (131 of 275) associated with accidental overdose.*
       A 2007 CDC population-based report estimates that, nationally, there are 1600 cases of ALF each year (all causes). Acetaminophen-related ALF was the most common etiology.**

* Larson AM, Polson J, Fontana RJ, Davern TJ, Lalani E, Lee WM et al. Acute Liver Failure Study Group (ALFSG). Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology, 2005 Dec;

   •    Summarizing data from five different surveillance systems, there were an estimated 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths related to acetaminophen-associated overdoses per year during the 1990-1998 period. ***

       It has been the policy of our clinic to monitor these doses carefully and to address the guidelines of 4 grams per day with each patient, suggesting alternatives when necessary. While we understand the concern for acetaminophen we also understand that the use of a short acting opioid combination product such as hydrocodone, properly prescribed and taken by informed patients, is an important tool in the management of both acute and chronic pain. The numbers in the advisory board suggest a problem, but given the liver injury numbers related to total doses purchased, (from the above briefing) we would hope that a more cautious approach to the problem, short of banning a valuable medication will be undertaken.
       We believe that total ban of these substances will likely lead to alternatives that may carry additional risks to patients. We will continue monitoring these events closely and will advise our patients appropriately as more details emerge.
       At this time we recommend following the existing guidelines of 4000 mg, using the lowest dose possible and considering alternatives when approaching 3000 mg. /day. A blood test, checking liver function can be performed and will be discussed at follow-up visit.
      In conclusion, the toxicity of acetaminophen has been recognized for many years. We have long discussed this toxicity and potential risk with our patients. The risk vs. benefit of the use of all medications must be carefully weighed by physicians and patients. We can not predict what the final outcome of the FDA advisory committee will be regarding these common medications. Be assured that SJ Pain Management Associates will monitor these FDA statements carefully and provide direction and alternatives for our patients if current medications are banned.

Richard L. Morgan MD
Vincent Johnson DO
Wayne Brown MD

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