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The U.S. Food and Drug Administration (FDA) has recommended that doctors stop prescribing and dispensing prescription drugs that contain more that 325 mg of acetaminophen per tablet or capsule to reduce the risk of severe liver injury.
The action targets prescription pain relievers that contain both acetaminophen and another ingredient, typically an opioid such as codeine (Tylenol with Codeine), oxycodone (Percocet) and hydrocodone (Vicodin). These drugs are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain or pain following dental procedures.
Over-the-counter (OTC) acetaminophen products are not affected by the recommendation. The FDA plans to address OTC acetaminophen products in another regulatory action.
In a statement, the FDA said:
Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death.
Cases of severe liver damage with acetaminophen have occurred in patients who:
- took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period
- took more than one acetaminophen-containing product at the same time
- drank alcohol while taking acetaminophen products.
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.