A federal advisory panel has recommended that the U.S. Food and Drug Administration (FDA) ban the painkillers Percocet and Vicodin because of their damaging effects on the liver, the New York Times reported on July 1.
The two popular painkillers combine acetaminophen with a narcotic. High doses of acetaminophen are believed to cause liver damage. The panel noted that, over time, people who take Percocet or Vicodin need to take higher and higher doses of the drugs to receive the same effect.
At least seven other prescription drugs that combined acetaminophen with narcotics also would be banned if the FDA follows the panel's recommendations.
The FDA asked the advisory panel to meet to address problems arising from the high demand for acetaminophen, which can be found in over-the-counter medicines such as Tylenol and Excedrin. In 2005, Americans bought 28 billion doses of products containing acetaminophen.
Although the medicine treats headaches and relieves fevers, liver damage can be caused in some people even when taking the recommended doses. More than 400 Americans die and 42,000 are hospitalized each year because of acetaminophen overdoses.
The committee also recommended that the FDA reduce the highest allowed dose of the ingredient in over-the-counter products such as Tylenol from 500 milligrams to 325 milligrams and to reduce the maximum daily dosage to no more than 4,000 milligrams.
Johnson & Johnson, the makers of Tylenol, said it “strongly disagrees” with the panel's recommendations. They said restricting the drugs would “lead to more serious adverse events as consumers shift to other over-the-counter products,” such as aspirin and Advil.
“The FDA will make a final determination and Abbott will follow the agency's guidance,” said Laureen Cassidy, an Abbott Laboratories' spokesperson. Abbott is the maker of Vicodin.
The panel also recommended limiting over-the-counter children's medicines containing acetaminophen to a single formulation to prevent doctors and parents from confusing the liquid and solid concentrations.