FDA: Stop prescribing combo drugs with high-dose acetaminophen


The Food and Drug Administration is turning to doctors, dentists, and pharmacists to accomplish what some drug manufacturers won’t help it do.

In 2011, the agency recommended manufacturers cease marketing of acetaminophen/opioid combination products with more than 325 mg of acetaminophen per dose, in an effort to reduce the risk of severe liver injury. Not all manufacturers complied.

Now, the agency on Jan. 14 issued a MedWatch recommendation that health care providers refrain from prescribing combinations with larger acetaminophen doses. The recommendation goes further, urging pharmacists to contact prescribers when they receive a prescription for a combination product with more than 325 mg of acetaminophen per dose to discuss a substitute product with a lower acetaminophen dose.

"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," the agency said, in a statement.

In the same 2011 notice, the FDA is requiring prescription acetaminophen combinations to carry a boxed warning on the potential for liver damage.

Acetaminophen-containing prescription combinations are among the most-prescribed pharmaceuticals in the United States, and include products such as Vicodin (acetaminophen/hydrocodone), Percocet (acetaminophen/oxycodone), and Tylenol with codeine.

The FDA has been examining acetaminophen since at least 2002. The recommendations of a joint meeting of several advisory committees in 2009 resulted in the 2011 policy changes and recommendations.

The agency now has sent letters to manufacturers that have not lowered the acetaminophen dose warning them that the FDA will withdraw approval of those products.

Physicians can report adverse events or side effects related to the use of acetaminophen products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online or at 800-332-1088.

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