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FDA sued over failure to ban painkiller
A consumer group has sued the FDA over its failure to remove a prescription painkiller from the market, arguing that it's too dangerous to stay on the market. The group, Public Citizen, had petitioned the FDA two years ago for it to ban the drug, propoxyphene, sold under such names as Darvon and Darvocet as well as many generic formulations. To date, the FDA hasn't responded to the group's request.
Now, Public Citizen has filed suit in U.S. District Court in Washington, arguing that the agency had violated the law by not ruling on its petition within the required six-month period. In its materials, the group argues that the propoxyphene is no more effective than other safer painkillers, noting that since 1981, there had been 2,000 accidental deaths associated with it. It also notes that even when used properly, propoxyphene is addictive and can cause serious cardiac side effects.
If the FDA did ban propoxyphene, it would be following in the steps of British health authorities, who ordered the drug to be withdrawn from use in 2005, citing accidental deaths and suicides. Still, right now it remains one of the most widely prescribed generic drugs in the U.S.
To learn more about the case:
- read this Associated Press article
- read the Public Citizen press release
Related Articles:
Public Citizen joins FDA review
Report faults FDA's post-marketing vigilance
FDA rejects Public Citizen's demand to pull Meridia
Comments
By Richard J. Yanno | Posted 1:40pm | February 2, 2009
To: Food and Drug Administration-
The Public Citizen who joined your medical advisory panel are a bunch of morons!
How can they even think that Darvon is a problem!
They are the same idiots that are allowing Roxicodone and Fentanyl Patches to destroy our society! These are the most addicting drugs I have ever seen! They have destroyed families and caused so many deaths. They have brought out addicts and drug dealers to rob drug stores. We have never had this problem before. I'm 54 years old so I have been around awhile.
I have been prescribed Darvon and Darvocet since I was 15 years old(knee injury). I since have had other physical injuries and am 100% disabled. I have learned to tolerate pain but when it gets real bad, I need my darvon/darvocet. They work on the pain, not a high to make you forget the pain like other prescription pain killers. And they are on the lower end of prescription pain killers.
As for the Roxi and Fentanyl Patches, I am qualified to testify of their deadliness. My fiancé who lived with me for 9 years and died December 16th, 2008 was prescribed both of these monstrous drug addicting substances. The drug companies are the drug dealers which you allow to bring pain and torment to our families and friends. You have allowed them to make our loved ones addicts. You have allowed them to have these drugs placed in their possession for them to control their dispersal. Anyone on these drugs are addicts! You don't ever allow an addict to dispense any Roxi or Fentanyl Patches. you never should have allowed any dispensing of these drugs. If someone is in that much pain, they should be in a hospital and any dispensing would be done in a controlled environment.
All patients who are on Roxi and Fentanyl Patches should be entered into Drug Rehabs to work on eliminating their addictions to them and both Roxi and Fentanyl Patches must be taken off the market and out of our society! This is the RESPONSIBLE thing to do.
We are still waiting for the toxicology reports from the autopsy. It looks like my fiancé succumbed from these legalized poisons you have let loose in our society. It's pure madness what you allowed the drug companies to do and it must be stopped. There comes a time when you must admit your wrongs for the good of the whole. Now is the time.
It's also time to put responsible members into the medical advisory panel and eliminate the morons!
Leave the Darvon/Darvocet prescriptions alone. They are one of the safest pain killers I have ever taken!
By M.Retallick | Posted 12:35pm | February 6, 2009
Concerning R.Yanno comments. I agree totally with him. I am 67 years old and have taken Darvocet for 10 years. I have never had a problem with it. It helps my severe pain. When I have a time where my pain is less I may go weeks without it, therefore I am not addicted. My Doctor said I didn't get addicted because I take it as prescribed. It helps me when I have severe pain more than any other drug ever has. Three of my previous pain relievers sent me to the Hospital, by affecting my liver.I feel Darvocet is safe when taken as diredted. Please don't remove it, it gives me a chance to have a normal life.
By Meg | Posted 8:53pm | April 10, 2009
I suffer from a chronic disease called intersticial cystitis. Darvocett is the only painkiller I can take that doesn't make me sick. I think with all medication, you must exercise moderation. i don't like to take narcotics to begin with, but when I'm feeling pain the Darvocett is the only thing that works for me. I don't know what else i could take that wouldn't make me sick. I certainly tried quite a few before being helped with the darvocett.
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