FDA Issues New Rules for Prescription Drugs w/Acetaminophen

The FDA has long been concerned about the amount of unidentified acetaminophen in prescription drugs such as Vicodin, Percocet, Lortab, Fioricet, and Roxicet. According to the FDA reports, acetaminophen, the active ingredient in Tylenol, is often found in large amounts in these, and other, prescription pain meds. Although when taken in normal doses Tylenol is very safe but when added to prescription pain pills, consumers can ingest large amounts of acetaminophen, which can lead to emergency room visits, hospitalizations, liver damage and even death. Statistics show that last year over 56,000 hospital ER visits, 26,000 hospital admissions and 458 deaths occurred due to acetaminophen overdose. In fact, it’s the leading cause of acute liver failure here in the US, because it’s so easy to take too much of it.

Within the next three years, the FDA has dictated that:

  • 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.

Obviously, these changes 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.

Our advice is to be aware of the acetaminophen in any prescription drug you take, as well as OTC (over-the-counter) medications, as 4,000 mg has been shown to cause liver damage. If you don’t know if there’s acetaminophen in a pain, cold or other preparation, whether OTC or by prescription, ask the pharmacist to explain it to you. Better safe than sorry!

To your health & beauty,

Vip Dev, MD

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