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FDA Panel Recommends Ban On Vicodin, Percocet

Posted by Chrissie Cole
Wednesday, July 01, 2009 12:14 PM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Acetaminophen, Tylenol, Percocet, Liver Damage, Painkillers

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IMAGE SOURCE: Wikimedia Commons / Vicodin

An FDA advisory panel voted 20-17 yesterday in favor of banning Vicodin and Percocet, two of the most popular prescription painkillers, as well as seven other acetaminophen/narcotic combinations and their generic equivalents due to toxic effects on the liver.

The narcotic portion of the drugs is not what has experts worried as you might think. It’s the acetaminophen aka Tylenol, which can be toxic to the liver.

The panel also voted that Tylenol should be given in smaller doses and the Extra Strength Tylenol should be sold by prescription only to reduce the dangers of serious liver injury.

The committee voted 24 to 13 to reduce the highest allowed dose of acetaminophen in over-the-counter pills such as Tylenol from 400 milligrams to 325. And members voted 21 to 16 to reduce the maximum daily dose to less than 4,000 milligrams.

But voted 20 to 17 against limiting the number of pills contained in each bottle, with members saying such a limit would probably have little effect and could hurt rural and poor patients.

While the agency is not required to follow recommendations made by the advisory panel, it usually does.

Acetaminophen, an aspirin alternative, has been in use for five decades to reduce pain and fever and has been the leading cause of liver injury for more than a decade, the FDA said.

Vicodin, sold by Abbott Laboratories and its generic copycats are the most popular drugs in the U.S., accounting for more than 100 million filled prescriptions last year, according to the New York Times.

Acetaminophen has been linked to 56,000 emergency room visits, as well as 26,000 hospitalizations and 458 deaths in the 1990s, according to the FDA.

Doctors are accustomed to handing out scripts for these drugs post-surgery, post-trauma and so on. Not to mention everyday use of acetaminophen-containing meds for headaches, fevers, colds and other ailments.

Most panel members agreed that consumers need to be better educated about the risks associated with popular medicines.

Pain-management experts note, that the narcotic portions of these painkillers and the acetaminophen can be prescribed separately. The decision now rests with the FDA. #


7 Comments

Anonymous User
Posted by carly
Wednesday, July 01, 2009 2:36 PM EST

Where has the FDA been all these years? aren't they supposed to be protecting us not the pharmaceuticals? There is a related post at LINK

Anonymous User
Posted by Jessica
Wednesday, July 01, 2009 6:19 PM EST

This is horrible. Some of us who have chronic disease and are in a lot of pain everyday need this meds to have some kind of quality of life.

Anonymous User
Posted by mary
Wednesday, July 01, 2009 9:58 PM EST

More government intervention in peoples lives. Where does that leave those in chronic pain?And how about those who cannot take the drug aspirin because of stomach trouble,aspirin is combined with narcotics to offer the other choice of pain reliever? Why cannot people be responsible for their own lives!

Anonymous User
Posted by Maureen
Thursday, July 02, 2009 2:47 PM EST

I think it is a bad idea to have combination drugs. However I don't think you can totally ban these drugs. I recently had kidney surgery and the pain was so intense after and for almost a week after that the hospital and doctor had to give me something. I actually vomited from the intensity of the pain. I can't take too many pain killers due to the delicate state of my stomach. However I know from past proceedures that I can take percocet. They waited as long as they could however they had to give me something strong they decided to give me 2 percocet. This lighted up the pain.

Anonymous User
Posted by Pithy
Sunday, July 19, 2009 5:00 AM EST

The FDA Meeting Issue Background Document is at:
LINK

Options 1(a) and 1(b) propose limitation of acetaminophen to 325mg per dose for OTC sales (and possible inclusion of all prescription formulations).

Option 5(b) proposes eliminating all prescription medications complexed with acetaminophen.

What is not (directly) stated by the FDA is the single most significant factor at play. Hydrocodone (Vicodin, Lortab) complexed with acetaminophen is a Schedule III medication. Hydrocodone (alone) is under Schedule II. And there currently is NO SUCH PRODUCT manufactured!

Thus, the FDA [if they choose to vote for Option 5(b)] will (effectively) "re-schedule" hydrocodone from Schedule III to the *much* more restrictive Schedule II (written prescriptions only, maximum 30-day supply, etc.).

Addressing the current non-existence of any hydrocodone (only) product, the FDA Background Document (lazily) states:
“For development of hydrocodone single-agent formulations, implementation would include:"
... "Submission of NDAs and ANDAs for single-ingredient hydrocodone products, which may also require clinical studies for demonstration of efficacy.”

A reported 460,000 prescriptions for hydrocodone with acetaminophen are written and filled every business day in the United States. (Despite) the fact that the public comment window has passed, all affected patients, physicians, and institutions would be wise to protest - loudly.

Anonymous User
Posted by Karlee
Friday, July 31, 2009 10:51 PM EST

this is pathetic and wrong!!

i have had 2 knee surgeries and have no idea WHAT i would have done without my pain medication. I tried taking tylenol and over the counter pain killers but the only thing that took the pain away was my vicodin.

there are way too many reasons to say that it is necessary we still have the ability to get ahold of these prescriptions.

Posted by Chrissie Cole
Saturday, August 01, 2009 12:58 AM EST

Thanks for all the comments, I understand and appreciate them.

My mom suffers from a chronic disorder and she takes Vicodin. If not for that some days she wouldn't be able to make it to work and that's really not an option for her right now.

Comments for this article are closed.

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