US FDA limits acetaminophen in Rx combo products; requires liver toxicity warnings

In a move that was expected given a previous advisory panel recommendation, the US Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325mg in each tablet or capsule.

The 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, also called APAP, is a drug that relieves pain and fever. It is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet, from Endo Pharmaceuticals), and hydrocodone (Vicodin, from Abbott Labs). According to IMS Health, total annual US sales of the products involved in 2009 were around $6 billion.