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FDA Alert: Liver Damage from High-Dose Acetaminophen


January 15, 2014 — In a new Safety Alert, the U.S. Food and Drug Administration (FDA) announced that half of prescription-painkiller manufacturers have missed a January 14 deadline to restrict doses of acetaminophen to 325-mg per pill or capsule, as the FDA ordered in January 2011.

In the near future, the FDA will withdraw approval for prescription painkillers that contain more than 325-mg of acetaminophen.

The FDA believes that limiting doses of acetaminophen will reduce the risk of accidental overdoses, which can cause severe liver damage, liver failure, or death. In addition, there is no evidence that taking more than 325-mg of acetaminophen provides any benefit that outweighs the risk of liver damage.

According to the FDA, more than half of all acetaminophen-related liver injuries were caused by accidental overdoses involving prescription painkillers. Vicodin, the most-prescribed painkiller since 1997, contains a combination of acetaminophen and an opioid.

Acetaminophen is also an ingredient in hundreds of over-the-counter medicines used to treat the most common ailments — cough, cold, fever, flu, and moderate pain. The problem is that many people are unaware that acetaminophen is an ingredient in these products, making it easy to accidentally overdose.

Life-threatening liver failure can occur in patients who overdose on acetaminophen by:

  • Taking more than the prescribed amount of acetaminophen in a 24-hour period.
  • Taking multiple acetaminophen-containing medicines simultaneously.
  • Drinking alcohol while taking acetaminophen.


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