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Home >  E-Weekly >  January 21, 2014

Limit Acetaminophen Amounts, Says FDA

Published: January 20, 2014

The prescriptions for post-op pain medications that you send your patients home with should not contain more than 325mg of acetaminophen per dosage unit, according to the U.S. Food and Drug Administration.

There is no evidence that administering more than 325mg of acetaminophen per tablet or capsule delivers benefits that are worth the risk of severe liver injury, says the agency. It adds that limiting acetaminophen dosage will reduce the risk of liver injury among patients who accidentally overdose on the drug.

"When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product," warns the agency's statement.

The FDA's recommendation follows a request it made to drug manufacturers 3 years ago to limit the amount of acetaminophen in their combined-drug products to 325mg by January 14, 2014. While some have complied, other products remain available, for which the agency says it plans to revoke its market approval. It also plans to deal with over-the-counter cough and cold products containing acetaminophen in the future.

David Bernard

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