Study: FDA tweak to combo painkillers may have saved lives
Acetaminophen, a popular over-the-counter medication for millions struggling with pain and fever, can also be found in prescription painkillers that combine acetaminophen and an opioid into one pill.
The problem? The U.S. Food and Drug Administration has long known that high dosages of acetaminophen — which goes by the brand name Tylenol — can harm the liver. So in 2011, the FDA set new safety limits on exactly how much acetaminophen could be packed into any prescription painkiller.
Now, a new study shows the move likely saved lives.
Ever since the FDA announced the regulatory change, which slashed the limits on acetaminophen from up to 750 mg to up to 325 mg, there has been an 11% to 16% annual drop in the number of hospitalizations and acute liver failure cases involving the combo painkiller. One such combo is Vicodin, which contains hydrocodone and acetaminophen.
“This suggests that the mandate was likely the largest driver in the decreases in acute liver failure cases and hospitalizations in combination acetaminophen-opioid products,” said study author Dr. Jayme Locke, director of the University of Alabama at Birmingham’s Comprehensive Transplant Institute.
The report was published this month in the Journal of the American Medical Association. Locke and her colleagues stressed that their investigation does not definitively prove that the FDA mandate directly caused acetaminophen-opioid drug complications to plummet.
According to the study authors, the intended purpose of combining acetaminophen with an opioid was to enable doctors to expose patients to lower doses of each of the two drugs. Given the burgeoning opioid addiction crisis, that approach made sense.
But researchers started to warn that at such high doses acetaminophen was proving toxic to the liver.