Limiting Acetaminophen Dose in Combo Medications Beneficial

MONDAY, March 13, 2023 (HealthDay News) -- Limiting acetaminophen dosage in prescription acetaminophen and opioid products is associated with a reduction in the annual rate of hospitalizations, according to a study published in the March 7 issue of the Journal of the American Medical Association.

Babak J. Orandi, M.D., Ph.D., from the University of Alabama at Birmingham Heersink School of Medicine, and colleagues examined the odds of hospitalization and proportion of acute liver failure (ALF) cases with acetaminophen and opioid toxicity prior to and after the U.S. Food and Drug Administration mandate to limit acetaminophen to 325 mg/tablet in combination acetaminophen and opioid medications, announced January 2011, with manufacturer compliance required by March 2014.

The researchers found that the predicted incidence of hospitalization was 12.2 cases per 100,000 hospitalizations one day prior to the FDA announcement and decreased to 4.4/100,000 hospitalizations by Q4 2019. The odds of hospitalizations with acetaminophen and opioid toxicity increased 11 percent/year before the announcement and decreased 11 percent/year after the announcement (odds ratio, 1.11 and 0.89, respectively). The predicted percentage of ALF cases involving acetaminophen and opioid toxicity was 27.4 percent one day prior to the FDA announcement and decreased to 5.3 percent by Q3 2019.

"The FDA mandate limiting acetaminophen dosage to 325 mg/tablet in combination acetaminophen and opioid medications was associated with a significant and persistent decline in the yearly rate of hospitalizations and proportion per year of ALF cases involving acetaminophen and opioid toxicity," the authors write.

Several authors disclosed financial ties to the pharmaceutical industry.

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