FDA Warns of Liver Damage From High Doses of Acetaminophen

Posted on January 16, 2014

The FDA warns high doses of acetaminophen over time can lead to liver damage. They are recommending doctors stop prescribing products that contain more than 325mg of acetaminophen per tablet.

FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. 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.
The FDA also says it will address OTC acetaminophen products in an upcoming regulatory action.

CNN's Elizabeth Cohen says "high doses over time" is the issue. She says you don't want to take more than 4,000 milligrams per day. Take a look:


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