FDA calls for cuts in Acetaminophen in painkillers

By Dr. Ananya Mandal, MDJan 13 2011

The US FDA has asked for a limit on the amount of acetaminophen in prescription pain medicines in an effort to reduce the risk of liver damage. The announcement yesterday asked manufacturers to limit combination drugs such as the opioids Percocet and Vicodin to 325 milligrams of acetaminophen per pill and asked them to carry a “black box” warning about potential liver failure. At present these combinations carry up to 750 milligrams of acetaminophen.

Sandra Kweder, a deputy director at FDA’s Center for Drug Evaluation and Research said, “Patients taking these prescription products often do not know they are taking acetaminophen at all… They don't realize that they’re overdosing.”

Manufacturers affected by this announcement include, Johnson & Johnson, Abbott Laboratories Endo Pharmaceuticals Holding Inc Watson Pharmaceuticals Incorporated and Boehringer Ingelheim’s Roxane Laboratories unit, among others. FDA said it was asking affected companies to comply but stopped short of ordering the actions. Changes would be phased in over three years.

Acetaminophen is often sold as a generic painkiller and Johnson & Johnson’s Tylenol. It is also one of the most commonly used U.S. drugs. It has been known to cause liver damage if patients overdose. Such overdoses cause nearly 460 deaths a year plus tens of thousands of emergency room visits and hospitalizations, FDA reported. It added that nearly 200 million prescriptions a year are written for such combination versions with high acetaminophen. Kweder added that the, “the amount of acetaminophen has gradually crept up over the years,” and that the dose reduction is not expected to affect patients’ pain relief. Kweder said over-the-counter versions can still contain “maximum strength” 500 milligram versions of the drug.

Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group while appreciating the move added that FDA should also deal with concern surrounding OTC acetaminophen medicines. About 80 percent of the acetaminophen market is non-prescription products, while about 20 percent includes prescription combination products, according to the FDA.