FDA panel recommends ban on Percocet and Vicodin

On June 30, 2009, a panel created by the Food and Drug Administration recommended that the agency ban Percocet (a combination of acetaminophen and oxycodone) and Vicodin (acetaminophen and hydrocodone).  The panel also voted almost unanimously to limit children's medicines containing acetaminophen to a single formulation in order to avoid confusion among doctors and patients over appropriate dosing.  The panel acted out of concern over the effects of these medications on the liver. 

High doses of acetaminophen are known to cause liver damage.  When used in a long-term pain medication that may require increased dosages for effective pain control, there is concern that liver-damaging levels of acetaminophen will be prescribed without adequate consideration of the potential for injury, due to the combined formulation.

Vicodin and its generic equivalents are prescribed more than 100 million times per year in the U.S. and consumers purchased 28 billion doses of acetaminophen in 2005.  More than 400 people die and 42,000 people are hospitalized each year from acetaminophen overdoses.  While combined formularies such as Vicodin and Percocet are more convenient for physicians, the FDA panel concluded that for the sake of safety, doctors and patients should prescribe and consume the medications  separately.