FDA-Mandated Tweak to Acetaminophen May Have Saved Lives

9 Mar 2023 • As per a report published in JAMA, the FDA's 2011 mandate limiting acetaminophen dosage to 325 mg/tablet in prescription acetaminophen and opioid products was associated with a statistically significant decrease in the yearly rate of hospitalisations and proportion per year of Acute Liver Failure cases involving acetaminophen and opioid toxicity.

Ever since the FDA announced the regulatory change regarding combining acetaminophen and an opioid into one pill, which slashed the limits on acetaminophen from up to 750 milligrams (mg) to up to 325 mg, there has been an 11% to 16% annual drop in the number of hospitalisations and acute liver failure cases involving the combo.

The investigators stacked pre-FDA mandate liver failure and hospitalisation risk up against post-mandate risk. They noticed was a dramatic drop in risk, coinciding with the FDA’s 2011 mandate. What did they observe?

  • NIS data revealed that while roughly 12 out of 100,000 hospitalisations involved combo drug toxicity just before the FDA move, that figure dropped to just above 4 in 100,000 by 2019.
  • And while the risk for being hospitalised with combo drug toxicity had been increasing 11% a year up to the time of the FDA’s new limit, that figure actually flipped to an 11% drop per year after the limit was announced.
  • Acute Liver Failure Study Group (ALFSG) figures revealed a similar dynamic: 27% of acute liver failure cases were attributed to the drug combo at the time of the FDA move, but that figure dropped to 5% by 2019

Source: US News | Read full story

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