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.
information, please visit: acetaminophen