An FDA advisory panel that was convened to review ways to reduce the risk of liver damage and death from acetaminophen, has recommended that a ban be issued on the use of popular medications like Vicondin and Percocet, which combine acetaminophen with other painkillers.
A Vicodin and Percocet recall would have to be approved by FDA, but the agency usually follows the recommendations of their advisory panels.
FDA research has shown that acetaminophen, the active ingredient in Tylenol, is the leading cause of liver failure in the United States. The advisory panel said users of medications that combine acetaminophen with narcotics increase the danger of acetaminophen liver damage and overdose because patients who take the drugs for long periods often need higher and higher doses to achieve the same effect. This means that their livers are receiving higher and higher doses of acetaminophen.
Following a meeting that began Tuesday to examine 11 different drugs that contain acetaminophen, the panel narrowly voted 20-17 in favor of the recall for Vicodin, Percocet and five other prescription painkillers that combine narcotics with acetaminophen. If the drugs are kept on the market, the panel voted 36-1 that they should carry a “black box” warning, which is the strongest warning that can be placed on a prescription medication.
Vicodin and generics that use the same active ingredients are prescribed more than 100 million times a year in the United States. However, safety issues are a serious concern, as more than 400 people per year die, and 42,000 are hospitalized, from overdoses due to drugs that use acetaminophen.
Panelists who disagreed with the recommended Percocet and Vicodin recalls said that withdrawing the popular medications would create an additional burden on people who deal with severe and chronic pain. Industry critics of the decision also say that the restrictions would lead to more health problems as people were suddenly forced to switch to different, less proven, pain medications.
In a separate vote, the panel voted 24-13 to restrict the maximum allowed dose of acetaminophen allowed in over-the-counter medications like Tylenol and NyQuil. The recommended restriction would limit the OTC painkillers to 325 milligrams per dose, down from 500, due to concerns about acetaminophen liver side effects. The panel also recommended that the maximum daily dosage be lowered to less than 4,000 milligrams.