Lupus Support Group

Hello Everyone!

For the last year, I have been warning the list about the toxicity of Tylenol/acetominophen, especially since it it often combined with the pain medications many of us so dearly need to control our pain. I have warned everyone that narcotic/Tylenol combination medications are NOT GOOD for long term pain control specifically because of the risk of Tylenol toxicity. While there are many toxicities that we cannot avoid, this is one that we CAN.

Today, the FDA called for restrictions on Tylenol and Tylenol combination drugs like Percocet and Vicodin. I am posting the article below from the Los Angeles Times, July 1, 2009, concerning this issue. I realize that some of you may have thought that I was Chicken Little as I trumpeted my warnings about this, but now the FDA has come out and made a SERIOUS STATEMENT concerning Tylenol.

If you take ANYTHING WITH TYLENOL IN IT, PLEASE TAKE THE TIME TO READ THIS ARTICLE.

Tracy

http://www.latimes.com/features/he...

FDA panel calls for restrictions on Tylenol, Vicodin, Percocet
To address deadly acetaminophen overdoses, experts recommend cutting the maximum dose of Tylenol and eliminating Vicodin and Percocet. Nyquil and Theraflu can stay on the market, they say.
Associated Press
July 1, 2009

Adelphi, Md. -- Government experts called for sweeping safety restrictions Tuesday on the most widely used painkiller, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin and Percocet.

The Food and Drug Administration assembled 37 experts to recommend ways to reduce deadly overdoses with acetaminophen, the leading cause of liver failure in the U.S., which sends 56,000 people to the emergency room annually. About 200 die each year.

"We're here because there are inadvertent overdoses with this drug that are fatal, and this is the one opportunity we have to do something that will have a big impact," said Dr. Judith Kramer of Duke University Medical Center.

But over-the-counter cold medicines -- such as Nyquil and Theraflu -- that combine other drugs with acetaminophen can stay on the market, the panel said, rejecting a proposal to take them off store shelves.

The FDA is not required to follow the advice of its panels, but it usually does. The agency gave no indication of when it would act.

In a series of votes Tuesday, the panel recommended 21 to 16 to lower the maximum dose of over-the-counter acetaminophen from 4 grams, or eight pills of a medication such as Extra Strength Tylenol. They did not specify how much it should be lowered.

The panel also endorsed limiting the maximum single dose of the drug to 650 milligrams. That would be down from the 1,000-milligram dose, or two tablets of Extra Strength Tylenol.

A majority of panelists also said the 1,000-milligram dose should only be available by prescription.

The industry group that represents Johnson & Johnson, Wyeth and other companies defended the current dosing that appears on over-the-counter products.

"I think it's a very useful dose and one that is needed for treating chronic pain, such as people with chronic osteoarthritis," said Linda Suydam, president of the Consumer Healthcare Products Assn.

The experts narrowly ruled that prescription drugs that combine acetaminophen with other painkilling ingredients should be eliminated. They cited FDA data indicating that 60% of acetaminophen-related deaths were related to prescription products.

But some on the panel opposed a sweeping withdrawal of products that are widely used to control severe, chronic pain.

"To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake," said Dr. Robert Kerns of Yale University.

If the drugs stay on the market, they should carry a black box warning, the most serious safety label available, the panel decided.

Percocet, Vicodin and similar treatments combine acetaminophen with more powerful pain relieving narcotics, such as oxycodone.
Posted on 07/01/09, 01:07 pm