Bye-bye Vicodin and Percocet?

[cryptique]

link

 

FDA panel votes to eliminate Vicodin, Percocet

 

Deadly overdoses of acetaminophen, narcotics are cited in recommendation

 

The Associated Press

 

updated 3:31 p.m. ET, Tues., June 30, 2009

 

ADELPHI, Md. - Government experts say prescription drugs like Vicodin and Percocet that combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses.

 

A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.

 

The FDA has assembled a group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the U.S.

 

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA.

 

Panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products. Acetaminophen is also found in popular over-the-counter medications like Tylenol and Excedrin.

 

“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.

 

Many opposed to recommendation

 

But many panelists opposed a sweeping withdraw of products that are so 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.

 

In a separate vote, the panel voted overwhelmingly, 36-1, that if the drugs stay on the market they should carry a black box warning, the most serious safety label available.

 

The FDA is not required to follow the advice of its panels, though it usually does.

 

Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to FDA data. Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both painkillers also are available in cheaper generic versions.

 

The FDA convened the two-day meeting to ask experts to discuss and vote on a slew of proposals to reduce overdoses with acetaminophen. The drug has been on the market for about 50 years and many patients find it easier on the stomach than ibuprofen and aspirin, which can cause ulcers.

 

Panel voted to lower maximum acetaminophen dose

 

Earlier in the day, panelists took aim at safety problems with Tylenol and dozens of other over-the-counter painkillers. In a series of votes, the panel endorsed lowering the maximum dose of those products.

 

FDA’s experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol.

 

The group was not asked to recommend an alternative maximum daily dose.

 

The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Johnson & Johnson’s Extra Strength Tylenol is 1,000 milligrams, or two tablets.

 

In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription.

 

However, panelists rejected a proposal to pull certain cold and cough medicines off the market because of their role in overdosing.

 

The drugs in question, such as Procter & Gamble’s NyQuil or Novartis’ Theraflu, combine acetaminophen with other ingredients that treat cough and runny nose.

 

The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.

 

But panelists cited FDA data that said the medications play a minor role in acetaminophen overdoses, with only 10 percent of acetaminophen-related deaths involving a cold and cough product.

 

“I don’t think we should be advocating a solution to a problem that really is not there,” said Dr. Osemwota Omoigui, of the Los Angeles pain clinic.

 

The panel voted 24-13 to keep the products on the market.

[Guest Speed Racer]

But couldn't they just repackage them as narcotic + buprofen? Kind of like when Coke switched to HFCS? I'm going to go out on a limb and say that if these are pulled, there will likely be a new narcotic/painkiller combo to (ab)use in short order.

[yermom]

I hear there's this thing out there commonly called "weed" that helps a lot of people with pain. I'm no doctor, but as far as I know it's easy on the liver. They should look into letting people use this "weed" stuff.

[bjorn_skurj]

I hear there's this thing out there commonly called "weed" that helps a lot of people with pain. I'm no doctor, but as far as I know it's easy on the liver. They should look into letting people use this "weed" stuff.

 

Your lips to IHVH's ears.

[bjorn_skurj]

And hydrocodone and oxycodone will still be available, I would imagine - they just don't want to combine it with Tylenol anymore. And they are leaving the magic sleep potion known as NyQuil alone.

[the_fliz1]

And hydrocodone and oxycodone will still be available, I would imagine - they just don't want to combine it with Tylenol anymore. And they are leaving the magic sleep potion known as NyQuil alone.

 

I have issues taking painkillers. I get really nauseous on Oxycodone and most other things I get prescribed. The only thing I am able to take that does any good is Vicoden. Everytime I have ever gotten prescribed Vicoden, the pharmacist gives me hydrocodone. I just always assumed that it was the generic version of Vicoden. Am I wrong?

[bjorn_skurj]

I have issues taking painkillers. I get really nauseous on Oxycodone and most other things I get prescribed. The only thing I am able to take that does any good is Vicoden. Everytime I have ever gotten prescribed Vicoden, the pharmacist gives me hydrocodone. I just always assumed that it was the generic version of Vicoden. Am I wrong?

No. Pharmacists can't just change your prescription. Unless the "dispense as written" box is scribbled in in their secret M.D. language, you will get the generic version because it is cheaper.

[austrya]

Hydrocodone is the synthetic form of codeine. It's the stuff in Lortab and Vicodin. Tylenol 3 w/ codeine is the same as vicodin except the codeine is the real stuff.

[Guest Speed Racer]

I'm sure some company overseas will still make it, and dealers here will sell it.

 

But they're not going to stop making the narcotic, they're just going to pull the acetominaphen and eventually replace it with another painkiller. This won't keep addicts from obtaining oxycontin, valium, or any number of other prescription drugs that don't have acetominaphen in them. If anything, this will push drugmakers to develop a painkiller that's a bit easier on the liver - inadvertantly reducing the long-term consequences for addicts. Not that addicts give a flying fuck what a pill is doing to their body, of course.

 

All weed ever did for me was slow me down and kind of dull pain - not in a pain-killing way, just in a "I can't feel my toes" sort of way. Maybe it's a dumb question (coming from someone who has never taken any of the medications we're discussing as-prescribed), but can you use weed therapeutically and still be functional?

[austrya]

I've never tried weed, but I know I can't take vicodin and still function. That stuff knocks me on my butt.

[Atticus]

Not that addicts give a flying fuck what a pill is doing to their body, of course.

 

some of them actually care quite a bit.

[Guest Speed Racer]

some of them actually care quite a bit.

 

That was a blanket statement, to be sure, but I think it would be accurate to say that regardless of one's emotional capacity to worry (and very truly care) about the physical consequences of drug abuse, the very nature of addiction means that the impulse to use always* trumps the consequences.

 

* until, one can hope, recovery.

[ih8music]

All I know is that if it weren't for vicodin, I would have had a really rough time recovering from my heel/ankle surgery a few years ago. I was held at the hospital for longer than expected because I couldn't manage my pain - nothing (morphine, etc) was working until they tried vicodin on me. I was still in a lot of pain, but it was reduced to a tolerable enough level that I was allowed to go home.

 

I personally was able to function fairly well on it - well, except for the time that I had a glass of wine with it, thinking it'd be no big deal... that combo knocked me on my ass, bigtime!