FDA warns acetaminophen hepatotoxicity

[WillBrink]

A warning to those who live on acetaminophen:


FDA recommends acetaminophen warnings
New report calls for dose limits to help reduce risk of liver damage
May 27, 2009

NEW YORK - A Food and Drug Administration report released Wednesday recommends stronger warnings and dose limits on drugs containing the painkiller acetaminophen, citing an increased risk of liver injury.

The recommendation covers both prescription doses and over-the-counter medication, of which Johnson & Johnson's Tylenol is the most well-known. Acetaminophen is also widely available as a generic over-the-counter drug.

"There is extensive evidence that hepatotoxicity (liver toxicity) caused by acetaminophen use may result from lack of consumer awareness that acetaminophen can cause severe liver injury," the working group report said.


The outside advisers will meet in June to discuss the report's findings. The recommendations include enhanced public information efforts, stronger labels warning of liver side effects, and dose limitations.

"Consumers may not be aware that acetaminophen is present in many over-the-counter combination products, so they may unknowingly exceed the recommended acetaminophen dose if they take more than one acetaminophen product without knowing that both contain acetaminophen," the report said.

The recommendations also call for limiting the maximum adult daily dose to no more than 3,250 milligrams, limiting tablet strength for immediate release formulations, and limiting options in liquid formulations for children.

http://www.msnbc.msn.com/id/30969044/

[DavidFourteen]

They put out a warning about this every few years. Acetaminophen is present in a BUNCH of products, and people double- or triple-dose (or more) themselves because they don't read the labels (which also typically have a warning regarding this).

[brantley65]

4 grams of APAP is considered hepatotoxic. Given the rise in pain killer combined with APAP, several pharmacists I know are having these chronic pain patients sign a disclosure that they were counseled each time about the potiential for liver damage with excess APAP. For example, with a Percocet 10 which contains 10 mgs oxycodone and 625 mg of APAP at a dosing rate of 1 to 2 Q 3 to 4 hours, a person can legal take 16 of these tabs a day. At that rate you are ingesting over 10 grams of APAP.

[WS6]

This is old news. However, it is good to see again!

Toxic levels of acetominophen are hard to achieve unless you have reduced renal perfusion or are some kind of addict or like another poster said, allergic to reading lables or think "if 1 is better, 10 is best!"