FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings 01-13-2011
The U.S. Food and Drug Administration is asking manufacturers of prescription combination
products that contain acetaminophen to limit the amount of acetaminophen to no more than 325
milligrams (mg) 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 and can be found in both prescription and over-the-counter (OTC) products. It is combined
in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with
Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). OTC acetaminophen products are not
affected by today's action.
The elimination of higher-dose prescription combination
acetaminophen products will be phased in over three years and should not create a shortage of pain
medication. Patients and health care professionals are being notified of the new limitation on
acetaminophen content, and of the labeling change, in a drug safety communication issued by CDER.
The FDA believes that prescription combination products containing no more than 325 mg of
acetaminophen per tablet are effective for treating pain.
Acetaminophen is also widely
used as an over-the-counter pain and fever medication, and is combined with other OTC ingredients,
such as cough and cold ingredients. The actions FDA is taking for prescription acetaminophen
products do not affect OTC acetaminophen products.
For more information, please visit: