FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings

January 18, 2011

FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule.

FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule.

FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

Acetaminophen is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin).

“It has been well documented for some time now that acetaminophen, while a widely popular and highly effective analgesic and antipyretic agent, does pose a significant risk of fulminant hepatic failure when overdosed,” said David Calabrese, RPh, MHP, Clinical Editor of Formulary, Drug Topics' sister publication.

“This action by FDA should be welcomed by our healthcare community as a positive step toward promoting improved quality of pharmaceutical care by limiting the potential for inadvertent acetaminophen liver toxicity and death,” said Calabrese, chief clinical officer, Med Metrics Health Partners, Worcester, Mass. “Our pharmacy and managed care professions should embrace these changes and do our part to help better educate the provider and patient community relative to these impending changes.”

The current maximum dose of acetaminophen is 4000 mg per 24-hour period.