Jul 9, 2009

Acetaminophen, a common prescription and over the counter pain management drug, has recently undergone a significant review by the Food and Drug Administration (FDA). On June 29 and 30, 2009, the FDA held an advisory committee meeting to discuss the problem of liver injury due to acetaminophen use. Acetaminophen is the leading cause of liver injury in the United States.

While the FDA is not bound by the recommendations of its advisory committees, it often follows their recommendations.  The recommendations of the acetaminophen advisory committee were significant and included:

  • Removing prescription drugs from the market if they combine acetaminophen with other painkillers;
  • Putting a black box warning, the most significant warning that the FDA can put on a drug, on prescription drugs that combine acetaminophen and other painkillers if the FDA does not remove the drugs from the market;
  • Lowering the maximum daily dose of nonprescription acetaminophen;
  • Lowering the maximum single dose of nonprescription acetaminophen; and
  • Allowing certain over the counter medications that combine acetaminophen with other medications for cold and flu symptoms to remain on the market.

Acetaminophen has been legally available in the United States for about fifty years and is in common household drugs such as Tylenol.  The recommendations of the FDA’s advisory committee are significant and may have a fundamental impact on the way people in the U.S. use painkillers in the years to come.