Acetaminophen-related liver failure

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On Jan. 13, 2011, FDA announced it is asking all makers of prescription products

that contain acetaminophen to limit the amount of the drug to 325 milligrams per

tablet or capsule

a.. requiring a Boxed Warning on all prescription acetaminophen products that

highlights the potential risk for severe liver injury. Boxed Warnings are FDA's

strongest warnings for prescription drug products, used for calling attention to

serious or life-threatening risks

In addition, FDA is requiring a Warning on labels of all prescription products

that contain acetaminophen that highlights the potential for allergic reactions.

These allergic reactions include swelling of the face, mouth, and throat;

difficulty breathing; itching; and rash.

Used effectively in both prescription and over-the-counter (OTC) products,

acetaminophen is among the most commonly used drugs in the United States.

Acetaminophen is used in many prescription products in combination with other

drugs, usually opioids such as codeine (Tylenol with Codeine), oxycodone

(Percocet), and hydrocodone (Vicodin). Examples of other prescription

acetaminophen combination products may be found in the List of Marketed

Acetaminophen-Containing Prescription Products, available online4. The label may

not spell out the whole word or may have an abbreviation, such as APAP, AC,

Acetaminophn, Acetaminoph, Acetaminop, Acetamin, or Acetam.

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Reports of Severe Liver Injury

FDA continues to receive reports of severe liver injury associated with the use

of products that contain acetaminophen.

Kweder, M.D., deputy director of FDA's Office of New Drugs, says the

agency's most recent action is aimed at making pain medications containing

acetaminophen safer for patients to use.

“Overdoses from prescription products containing acetaminophen account for

nearly half of all cases of acetaminophen-related liver failure in the U.S.,

many of which result in liver transplant or death, " says Kweder.

Most of the cases of severe liver injury occurred in patients who

a.. took more than the prescribed dose of an acetaminophen-containing product

in a 24-hour period

b.. took more than one acetaminophen-containing product at the same time

c.. drank alcohol while taking the drug

“There is no immediate danger to patients who take these combination pain

medications and they should continue to take them as directed by their health

care provider,” says Kweder. " The risk of liver injury primarily occurs when

patients take multiple products containing acetaminophen at one time and exceed

the current maximum dose of 4,000 milligrams within a 24-hour period.”

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm239747.htm