Public education on acetaminophen dangers vitally important

WASHINGTON — While progress has been made in helping people recognize the potential dangers associated with acetaminophen use and its connection to acute liver failure, the idea of doctors regularly touting use of an over-the-counter treatment that was once termed a “suicide agent” in the United Kingdom remains problematic, a speaker said here.

“It’s now, ‘Tylenol: No. 1 doctor recommended,’ ” William M. Lee, MD, of the division of digestive and liver diseases at the University of Texas Southwestern Medical Center and the division of gastroenterology, hepatology and nutrition at Ohio State University, said at The Liver Meeting while showing a photo of an advertisement he saw for Tylenol and not the implication of relative safety.

William M. Lee

“Let’s think about that … what else was doctor recommended?” he asked, forwarding his presentation to a slide of decades-old advertisements of doctors espousing the use of cigarettes with headlines such as “More doctors smoke Camels than any other cigarette” and “20,679 physicians say Luckies are less irritating.”

In delivering the Hyman J. Zimmerman Hepatotoxicity State-of-the-Art Lecture entitled “Acetaminophen and the Liver: Poison or Panacea,” Lee noted considerable progress has been made, but more must be done to reduce the annual number of acute liver failure episodes and deaths related to the drug.

In recent years, the clinical syndrome related to acetaminophen overdose has been characterized, Lee noted. And soon prognostic tests and an assay to detect unrecognized cases may be available, he said.

Despite these and other advancements, however, there has been no decline in cases observed, suggesting the importance of better understanding of acetaminophen and the potential need for further restrictions.

“I think we made some strides; I think the FDA is on board, but it’s awfully slow,” Lee said.

Among potential efforts being considered are stronger limits on daily dosing; reducing the number of pills per package and/or changing packaging to blister packs to help users better understand dosing; stronger side effect warnings, similar to those for prescription products; suggestions to begin dosing with one tablet instead of two; unbundling of opioids; limiting dosing to 325 mg; and more.

Disclosure: Lee is a consultant with Eli Lilly and Novartis, receives grant/research support from Gilead, Roche, Vertex, BI, Anadys, BMS and Merck and receives speaking/teaching funds from Merck.