FDA Alert: Liver Damage from High-Dose Acetaminophen

January 15, 2014 — The U.S. Food and Drug Administration (FDA) is warning that some prescription painkillers still contain more than 325-mg of acetaminophen, despite FDA action in January 2011 to take such doses off the market.

More than half of manufacturers have complied by the January 14 deadline, and the FDA will soon withdraw approval for prescription drugs containing more than 325-mg of acetaminophen.

The problem is that many consumers are unaware that acetaminophen is an ingredient in hundreds of over-the-counter and prescription painkillers, making it easy to accidentally take too much. Accidental overdoses of prescription painkillers account for nearly half of all acetaminophen-related liver injuries.

According to the FDA:

“There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.”

Severe liver injury from acetaminophen can occur in patients who:

• Take more than the prescribed dose of acetaminophen in one day.
• Take more than one medicine containing acetaminophen at the same time.
• Drank alcohol while taking acetaminophen.

Vicodin, the most-prescribed drug since 1997, is a painkiller combines acetaminophen with an opioid painkiller. Acetaminophen is also an ingredient in many over-the-counter medicines for pain, fever, cough, cold, and flu.