Worries about Acetaminophen Results in new FDA Dictates

When taken as directed on the bottle, acetaminophen, which is the primary ingredient in Tylenol, has long been a safe and reliable pain medication. However, you may be surprised to learn that large amounts of acetaminophen are found in certain prescription pain drugs, such as Vicodin, Percocet, Lortab, Fioricet, and Roxicet, among others. A problem arises when physicians and consumers are not aware of the amount of acetaminophen that’s added to these prescription pain relievers, because accidental overdoses can occur. In fact, it takes only 4,000 mg of acetaminophen ingested in a single day to cause liver damage.

Overdoses of acetaminophen were responsible for 56,000 hospital visits, 26,000 hospital admissions and nearly 500 deaths last year. It may surprise you to know that acetaminophen-caused liver damage is the #1 cause of acute liver failure here in the US.  It’s fairly easy to take too much, particularly when a patient is unaware that he or she is ingesting large amounts of acetaminophen in prescription drugs.

To address these problems, the FDA has dictated the following changes over the next 3 years:

  • Prescription pain drugs can contain no more than 325 milligrams of acetaminophen per pill or spoonful. Currently, some of these drugs contain as much as 750 milligrams of acetaminophen.
  • Prescription pain drugs will carry the FDA’s strongest “black box” warning label. That label will warn of the risk of serious liver injury.

These dictates apply only to prescription drugs.

“When taken as directed, acetaminophen is a very safe product. Our goal is to make it even safer,” Sandra Kweder, deputy director of the FDA’s office of new drugs, said at a news teleconference.

My advice to my readers is to be aware of the presence of acetaminophen in any drugs you take, whether prescription drugs OTC (over-the-counter). If you aren’t sure whether a medication also contains acetaminophen, ask your pharmacist to read the container and tell you. It’s not always easy to identify it, believe it or not.

To your health & beauty,

Dr. Laurence Weider