Vicodin and Percocet to Be Pulled Off the Market?

Medical Author: Melissa Conrad Stöppler, MD
Medical Editor: William C. Shiel, Jr., MD, FACP, FACR

On June 30, 2009, an advisory committee to the U.S. Food and Drug Administration recommended that the FDA restrict the use of acetaminophen, the widely-used pain medication found in products such as Tylenol and Excedrin. Acetaminophen is also referred to as paracetamol in other countries and is a component of in many prescription drugs as well as over-the-counter remedies. The reason for the crackdown is the potential for liver damage that can occur when too much of the medication is taken. Acetaminophen overdoses account for around 56,000 emergency room visits per year in the U.S. and resulted in 356 deaths in 2006.

Taken in recommended doses, acetaminophen is a safe and effective pain-killing (analgesic) and fever-reducing (anti-pyretic) agent. The use of acetaminophen instead of aspirin to treat fevers and other conditions in the pediatric population has greatly reduced the occurrence of Reye's syndrome, an often fatal form of liver failure.

For the average healthy adult, the recommended maximum dose of acetaminophen over a 24 hour period has been considered to be four grams (4000 mg). Each extra-strength Tylenol pill currently contains 500 mg, and each regular strength pill contains 325 mg. Taking about twice the recommended dose can result in liver damage in a healthy person.