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Aaron747
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FDA Finally Bans Painkiller After 30 Years?

Sun Nov 21, 2010 7:18 am

Apparently we have yet another example of gross incompetence by federal oversight agencies that need to do their damn job. What is the excuse this time?? The warnings started in 1978 but it wasn't until 2009 that the FDA formally asked the maker of Darvon/Darvocet to do an official study on potential risks of fatal heart arrythmias caused by the drug? Sorry, but that's just unbelievable. Watch for some massive lawsuits - thanks to the government's incompetence, taxpayers are now going to be dishing out class action settlement money to the families of people killed by this drug - especially if there are really as many reports from medical examiners as it seems.

"The FDA's deadly delay in this case starkly illustrates how one of the most important public health concepts, the precautionary principle, was embraced by the UK and Europe, but was for too long recklessly rejected by the FDA," said Dr. Sidney Wolfe, of the consumer watchdog group Public Citizen.

Wolfe estimated that at least 1,000 to 2,000 U.S. patients died from taking Darvon since the U.K. banned the product in January 2005.

Public Citizen petitioned the FDA to ban the drug in 1978 and again in 2006, pointing to its role in thousands of deaths reported by state medical examiners.


I'm all for careful scientific study, after all there's no reason to pull something off the market over ODs as just about anything will kill someone - but even two or three cases of people dying as a result of therapeutic doses should have been enough to have FDA order further study.

http://www.denverpost.com/business/ci_16657723
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N1120A
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RE: FDA Finally Bans Painkiller After 30 Years?

Sun Nov 21, 2010 5:38 pm

Quoting Aaron747 (Thread starter):
Watch for some massive lawsuits - thanks to the government's incompetence, taxpayers are now going to be dishing out class action settlement money to the families of people killed by this drug

The government is not likely to see liability here. Lilly is financially secure and will likely see the brunt of this. Remember - products liability is strict liability.
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Aaron747
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RE: FDA Finally Bans Painkiller After 30 Years?

Sun Nov 21, 2010 8:04 pm

Quoting N1120A (Reply 1):
Lilly is financially secure and will likely see the brunt of this.

The FDA received reports about fatal results from the drug and failed to order studies or otherwise take action. To succeed against Lilly, they would have to prove they suppressed data about its harmful effects - hard to do if any such action was taken 30-40 years ago.
If you need someone to blame / throw a rock in the air / you'll hit someone guilty
 
CaliAtenza
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RE: FDA Finally Bans Painkiller After 30 Years?

Sun Nov 21, 2010 10:41 pm

im not familiar with this drug, but i just looked it up and i saw that its in the opoid class. Yeah this is prolly still used in many countries outside the US where drug oversight is slim to none. You should see some of the wacky combinations they have here in India...
 
dxing
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RE: FDA Finally Bans Painkiller After 30 Years?

Mon Nov 22, 2010 1:58 am

So along with my accutane, phen phen, percoset, avandia, and bextra scrips as well as working in a shipyard, I guess I'm in for some trouble down the road?
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KevinL1011
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RE: FDA Finally Bans Painkiller After 30 Years?

Mon Nov 22, 2010 2:43 am

Quoting N1120A (Reply 1):
Lilly is financially secure and will likely see the brunt of this. Remember - products liability is strict liability.

Wouldn't any medical professional (MD/ RX) who prescribed or provided the drug to a patient be named in a lawsuit as well?
I can't wait for the TV commercials from Attorneys asking "If you or a loved one has been prescribed Darvon or Darvocet and have experienced cardio arrhythmia, liver disease or death, call this toll free number NOW! You may be entitled to compensation.".

Quoting dxing (Reply 4):
I guess I'm in for some trouble down the road?

Not to mention exposure to 50K watts of RF!

[Edited 2010-11-21 19:38:28]
474218, Carl, You will be missed.
 
N1120A
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RE: FDA Finally Bans Painkiller After 30 Years?

Tue Nov 23, 2010 3:53 am

Quoting Aaron747 (Reply 2):

The FDA received reports about fatal results from the drug and failed to order studies or otherwise take action.

Again, that isn't the course in these kind of actions.

Quoting Aaron747 (Reply 2):
To succeed against Lilly, they would have to prove they suppressed data about its harmful effects

Not really. Just that they marketed it as safe, which they did.

Quoting dxing (Reply 4):
accutane
Quoting KevinL1011 (Reply 5):
Wouldn't any medical professional (MD/ RX) who prescribed or provided the drug to a patient be named in a lawsuit as well?

No. Not unless they had specific knowledge. Besides, it makes more sense to go after the maker of the flawed product.
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johnboy
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RE: FDA Finally Bans Painkiller After 30 Years?

Tue Nov 23, 2010 5:59 am

I haven't handed out a Darvocet for at least 10 years now.
I had no idea they were still being prescribed!
 
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DocLightning
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RE: FDA Finally Bans Painkiller After 30 Years?

Tue Nov 23, 2010 9:54 pm

Quoting johnboy (Reply 7):
I haven't handed out a Darvocet for at least 10 years now.
I had no idea they were still being prescribed!

Ditto. Admittedly, I almost never prescribe narcotics in general pediatric practice.
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N1120A
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RE: FDA Finally Bans Painkiller After 30 Years?

Thu Nov 25, 2010 9:39 am

I took Darvocet just a couple times in combating pain from having my wisdom teeth removed. I was originally prescribed Vicodin, but the heavier narcotic effect of the Vicodin just was something I had no interest in, so I was switched to the milder Darvocet. It worked and didn't make me nearly as stoned, but its been known to be pretty so so for a while now.
Mangeons les French fries, mais surtout pratiquons avec fierte le French kiss
 
dxing
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RE: FDA Finally Bans Painkiller After 30 Years?

Thu Nov 25, 2010 2:16 pm

Quoting N1120A (Reply 9):
I took Darvocet just a couple times in combating pain from having my wisdom teeth removed.

That explains a lot...thanks for sharing.         
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mdsh00
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RE: FDA Finally Bans Painkiller After 30 Years?

Thu Nov 25, 2010 4:26 pm

Who the hell even gives out darvocet anymore? These days it's usually Tylenol #3 (my preferred starting point), percocet, Oxycontin, and Percocet...
"Look Lois, the two symbols of the Republican Party: an elephant, and a big fat white guy who is threatened by change."
 
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flyingclrs727
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RE: FDA Finally Bans Painkiller After 30 Years?

Fri Nov 26, 2010 7:02 am

Quoting N1120A (Reply 9):
I took Darvocet just a couple times in combating pain from having my wisdom teeth removed. I was originally prescribed Vicodin, but the heavier narcotic effect of the Vicodin just was something I had no interest in, so I was switched to the milder Darvocet. It worked and didn't make me nearly as stoned, but its been known to be pretty so so for a while now.

I was prescribed Darvocet in 2001 by my physician while I was waiting for an appointment with a neurosurgeon. I was in so much pain that I could feel the effects of the Darvocet start to wear off after 4 hours which was a big problem, because his instructions said not to take more than 4 per day. My neurosurgeon switched me to Vicodin which was much more effective, and at least I was able to have pain relief so long as I didn't have to stand up or walk. I didn't feel high when I took Vicodin, but it did make me moody. Fortunately I got fast tracked into an appointment to have a myelogram the day after I had my first appointment with my neurosurgeon. This was fortunate, because when he called me with the results of the myelogram and CAT scan, he said I needed to make an appointment for the earliest available surgical slot on his schedule and that my disc was completely surrounding my spinal nerve and I was in danger of permanent nerve damage. I was able to cope with the pain in the 10 days between my first appointment and surgery taking 4-5 Vicodins a day even though my prescription said I could take up to 6. I was able to cut off all narcotics just a week after my surgery.
 
N1120A
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RE: FDA Finally Bans Painkiller After 30 Years?

Fri Nov 26, 2010 3:48 pm

Quoting dxing (Reply 10):

That explains a lot...thanks for sharing.

Well, it beats the full frontal lobotomy you apparently got  
Quoting mdsh00 (Reply 11):

I thought Oxycontin was only rarely prescribed anymore.
Mangeons les French fries, mais surtout pratiquons avec fierte le French kiss

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