Pain Relief: FDA Panel Urges Ban on Darvon, Related Drugs

Acting on a petition from the public interest group Public Citizen, a Food & Drug Administration (FDA) advisory panel last Friday voted narrowly to recommend that a widely used opioid pain medication be removed from the market. The drug is prophoxyphene, which has been in the pharmacopeia for more than a half century, and is most widely prescribed under the brand names Darvon and Darvocet.

https://stopthedrugwar.org/files/darvon65mg.jpg
65 mg Darvon pills (usdoj.gov)
Prescribed for the relief of mild to moderate pain, prophoxyphene is used in dozens of generic pain medications, too. According to a briefing paper prepared by Xanodyne Pharmaceuticals, the manufacturer of Darvon and Darvocet, some 26 million prescriptions for the pain-fighting pair were written in 2005.

The FDA approved new Darvon formulations as recently as 2003 and a generic phophoxyphen pain medication in 2005. The drug has also passed a number of FDA reviews in the past half-century, including one occasioned by another Public Citizen petition in 1978. The FDA can ban a drug if it is proven unsafe or ineffective when taken as directed.

The agency collected reports of more than 1,400 deaths in people who had taken the drug since 1957, though experts stressed the figure does not prove the drug was the cause of death in all cases. Nor does it seem an exceptionally large figure for an opioid drug prescribed millions of times a year for more than 50 years.

The panel also relied on a Florida Medical Examiner Commission report on 2007 drug-related deaths that showed 87 deaths linked to prophoxyphene.

"If that's not a risk, I don't know what is," said Dr. Sidney Wolfe, head doctor for Public Citizen.

There may be a risk, but it's relative. That same report listed 476 deaths caused by alcohol poisoning, 743 from tranquilizer overdoses, and 843 from cocaine. Among opiate-caused deaths, methadone led with 785, then Oxycontin with 705, hydrocodone with 264, morphine with 255, Fentanyl with 117, and heroin with 93 -- all greater than the number of deaths attributed to Darvon and its generic equivalents. Even the tranquilizer Meprobamate killed more people with 88 deaths listed. (Cannabis was listed as the cause of death in zero deaths.)

Still, despite weak evidence to justify removing Darvon and its brothers from the pharmacopeia, the FDA advisory panel voted to recommend that 14-12 last Friday. A final decision will come in a few weeks.

"It's not a very clear-cut picture," Sharon Hertz, MD, deputy director of the agency's analgesia drugs division, said at a press briefing after the decision. "It's not straightforward that it should or shouldn't come off the market."

Some panel members saw little benefit in keeping Darvon on the market. "I would say, little 'b', big 'r' for this drug. That's little benefit and lots of risk. And that's unsettling," said Ruth Day, PhD, who voted to remove the drug.

It "looks like it offers placebo benefits with opioid risks," saids Sean Hennessey, PhD, a panel member and epidemiologist from the University of Pennsylvania.

But other panel members warned that banning prophoxyphene could leave pain patients in the lurch. It could also drive them to other pain, more potent pain medications, like Oxycontin, they warned.

"Every drug you're talking about that's going to deal with pain has difficulty," said Mary Tinetti, MD, a professor of medicine at Yale University. "There is the possibility that the drugs that would take its place would cause at least as much harm in some people."

Xanodyne hopes it can keep the drug on the market. "I'm hoping to do everything we can to keep this product available to the 22 million people who need it," the company's vice president for clinical development and medical affairs, James Jones, told WebMD.

Permission to Reprint: This article is licensed under a modified Creative Commons Attribution license.
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Darvon, Darvocet,

Darvon, Darvocet, DIstalgesic- the worst drugs ever

We have studied the painkilling substance Propoxyphene – Darvon, Darvocet, Distalgesic and Co-Proxamol – since 1994 and we think these drugs are the worst drugs ever. If you want to know more about what we think, please go to YouTube ;

http://se.youtube.com/watch?v=vw5O4tgErsg

Drs Ulf and Birgitta Jonasson, Sweden

More context needed

The argument seems to be that prophoxyphene combined with other common drugs becomes far more toxic than other opiates, and that the attributed deaths may be severely under-reported due to "the lack of disclosure of the generic firms ... if the US had the same system as the UK for taking blood samples and running tox screens on all unexpected deaths we would find the death rate from Darvon much higher than is presently reported." - from the comments of the YouTube vid above.

I can't jump on the side of a pharmaceutical company without seeing a clearer picture. The drug at least needs a period of closer scrutiny in the U.S. If the drug is truly weak with large risks for *regular* use, I can see the issue.

why

so why is it that all these legal drugs have killed so many people and yet they remain legal when there is a herb like marijuana witch has never killed anyone and never will but yet its still illegal and has be since 1937 why is that???????

Whats the real story here?

Are they taking this drug off the market to give more profits to big pharma companies that are selling drugs still protected by patent?

Darvon is no longer protected by patent, which means the profit margins are slim.

Great!

With the war on pain doctors continuing, people will have just one more medication they cannot be prescribed. They can't get the opiates for their pain because the DEA has decided, it is bad for doctors to treat chronic pain that way. They have put doctors in prison for it, you know! Because, the DEA has all the brains to be able to tell you, they know more than your doctor! Sad thing is, there are too many laymen who think they are smarter than doctors, too! All I can do is hope, there really is a God! And, that they will suffer from chronic pain, one day, that no one will treat, out of fear of the repercussions from the authorities!

That is even a bigger reason to push for medical cannabis! There are many anecdotal claims that it helps the chronic pain patients decrease opiate need! Anecdotal, because the research has been prevented by the DEA! I guess they have no compassion for people in pain! They attack the problem from all sides!

U of CA study: opioids + cannabis = 30% increase in pain relief!

Here's a study showing 30% increase in pain relief for HIV neuropathy pain:
http://www.nature.com/npp/journal/v34/n3/full/npp2008120a.html

While I don't have HIV, I do have HepC neuropathy and I know that I've seen immediate & complete pain relief from indicia/sativa vapor.

Due to finances and legal concerns, though, I don't use cannabis, but rely on opioids. Oxycodone is a nightmare; my doc prescribes it but I won't take it again. Now using Hydrocodone, but if cannabis were legal & available, it would allow enough pain relief to be productive ... keep working, feel good & think straight. People don't understand how hard it is to just do simple things when in constant central nervous system pain. If I took enough hydrocodone to not be in pain, I'd be brain-fried and addicted. Not so with cannabis. 2 puffs, pain gone, and productive for 3 - 4 hours...not stoned or zonked out, just OK and normal. When I told VA docs my cannabis story, they wrote me up as drug addict and recommended treatment for marijuana abuse. Then prescribed oxycodone. WTF???!!!!

Pain

I pray that everyone who works at the DEA will end up with horrific chronic pain so they can finally see what it is and that it is all too real. And I hope like most of us, they will have a hell of a time finding any doctor to help them. Thanks to them even the Cleveland Clinic won't prescribe oxy at their PAIN Management Clinic!
These people are like terrorists and I am so sick of them hassling the most helpless people in our society; people in chronic pain.
They love to go after pain docs because it is involves little risk and is easy pickings. Then, it looks like they are actually accomplishing something.
And why is medical cannabis such a problem for people? Alcohol has caused way more suffering than marijauna ever has. How many people have had their lives destroyed due to drunk drivers? And families due to alcoholism and the violence that usually comes with it?
I cannot wait for all the people out there who don't have pain to get some and see how they like it.

Good Article

Great article. Only problem was that the drug warriors will point out that it was carried out by the Center for Cannabis Research, claiming it would be biased. Although it was a randomized double blind study, they will still attempt to derail any claim of benefit, I am sure. I know, by personal experience, that it relieves neuropathic pain, even in the absence of opiate therapy! But. that is only anecdotal. There are too many doctors, either in jail, right now, or careers ruined by the war on drugs, and its backwards thinking, when it comes to compassionate therapy for chronic intractable pain! Believe me, I know! And VA docs are probably the worst at treating intractable pain! Even though, they have had information that tells them that true pain patients rarely get addicted!

Guideline for Prescribing Opioid Pain Drugs Published

The Journal of Pain (Vol. 10, Issue 2, February 2009, pp. 113-220) has just published a series of articles dealing with opioid treatment guidelines which may help frame the debate on the drug/pain issue.

Journal of Pain

Almost all, of the articles, called for further research in the "perspective" section. I cannot access the journal, other than reading the abstracts. Guidelines are supposed to be used as such---guides to treatment. So much of the time, organizations, like the DEA, try to make it "standard of care" and pervert the entire scientific process. Patients are not 100% capable of being treated within most guidelines. Although, many can be, effectively, treated that way. Since 95% of physicians will not treat chronic pain with opiates, the 5% that do are outliers. And we know what that will get you, if you have to deal with the DEA! Sort of ends up getting run like a democracy. Not any fun when you are the, minority, sheep amongst the, majority, wolves! You will be devoured! I like a Constitutional Republic better!

Thanks for the reference, Giordano

Opiod pain medication

I am the life partner of a chronic pain patient who uses narcotics to get something approaching a life. Imagine feeling hot coals under you skin, razors slicing you if you shower, molten hot metal in your limbs every minute of every day. Welcome to CRPS(RSD) Cannabis does not help her much, so those who think it is a all purpose replacement for opiods are WRONG. Some freak that she needs these drugs to function. I guess a diabetic is a hopeless insulin junkie. Wean them off it now!! Those patients who need opiods have no rights that need be respected by anyone. I think Darvon isn't that great a drug but if it helps some people it should not be banned. Life is dangerous. If someone needs Oxycontin to have even a couple hours of activity a day what is so wrong with that? I am so sick of those who see opium based medication as the evil molecule. The DEA needs to get out of the medicine business and let people get the meds they need. If a few abuse it so what. If some die (usually form mixing with alcohol) so what. People die. Our obsession with preserving life at all costs makes the quality go to shit.

and the beat goes on...and on....

Loved your comment. The corporate DEA needs to be gone, yesterday. Chronic pain is the end of life as you knew it , if you are a person who suffers NEEDLESSLY due to the clones of sheep the DEA has managed to produce, encompassing huge 5of Licensed physicians

Koodos to your voice being read (at least by myself : ] )

It's just another day in the police state called america

Pay to Play

Chronic Pain & the DEA

I am, like you, in CHRONIC, EXCRUCIATING pain.  I've had 28 years of back pain and was told for 10 of those years (by doctors) that if was "ALL IN MY HEAD". Being that these were not interns or, I hope idiots, OF COURSE THE PAIN IS IN MY HEAD...SINCE THAT IS WHERE a persons pain center is!  Six months ago I was diagnosed with bilateral peripheral myopathy.  This attacks me in the middle of the night. Just sleeping nicely (which in itself is a miracle) and all of a sudden I wake up feeling like somebody took my hands and feet, poured gasoline on them and lit them up. The pain is SO BAD I've actually considered suicide as a viable option, but I'm Catholic and don't want to burn for eternity. My point is that was my diagnosis, but there are literally hundreds of kinds of peripheral myopathy, but my neurologist never told me that or what kind I have so that I could be treated properly.  12 Years I had my cholesterol tested, not  knowing ANYTHING about what those  numbers meant.  I was told that my total cholesterol was 200 and that my triglycerides were 300, but never told me that was high and the way he said it he made it sound like I shouldn't worry about it, so I didn't.  I just had it checked again when I started having chest pains and my total cholesterol is 298 and my triglycerides 355.  My doctor immediately sent me to a cardiologist who did the test again, also did a EKG, stress test, and an angiogram. He put me on a heart healthy diet, told me to quit smoking (which I really knew I would have to do no matter how the tests came out), told my to exercise, and put me on plavix and a statin drug.  But to make a long story longer I fully understand what you are saying about the DEA, before I moved to Arizona, I had 2 ruptured discs, had 3 back surgeries, sciatic nerve damage and was in constant pain and all I could get was Ultram. Once I moved to Arizona, I found a doctor who was compassionate enough to give me medication that actually works.  That may be a good answer for you.  Good climate, Good doctor (at least mine).  Give it a thought,.

Couldn't have said it better

Couldn't have said it better myself! The fact that the highest level of addiction, in real pain patients, is 3% (lowest .008%) that means 97% (or more) of the rest of us are left to suffer because of the insanity! I hope that doctors are given back their rights to practice compassionate medicine, and not the corporate kind, driven by the bottom line, and greed! But, with the "change" coming I only predict a worse environment, in which to practice medicine!

The DEA also manipulates medical board actions in some states, so the real number of physicians affected is likely much higher than what their statistics would show. They would not want themselves to be viewed negatively, by the public. Well, you know, they are government representatives!

I know about on of those deaths in my past practice. The guy took his first pill of a new medications, and he ended up in the regional hospital's ER. They put him in the hospital a couple of days, until he got over it, then sent him home. He took another pill and ended up DOA at our local ER. Guess whose fault the ER doc told the medical board it was! Not the guys, at the regional hospital and ER, who treated a patient for a drug reaction, did not call his local doctor, and sent the patient home to take the exact medicine that they should have known, would kill him! The doctor who had no idea any of this had happened, was the one that was blamed! Politics in medicine can be real ugly, too.

This man died not from a pain medication. He died because he was allowed to take that deadly medication a second time! But, statistics show it as an "overdose" death. Tell me ! How does one die of an overdose from one pill?! (not a chewed or crushed Oxycontin)

That, actually, was another case that happened in the nursing home, where the nurse bragged, that she finally got the crushed Oxycontin down the patient's throat! That malpractice suit, against the nursing home, was laughed out of the lawyer's office! She just died of old age and dehydration caused by organic brain syndrome and obtundation! HELLO! She was obtunded because they gave her an overdose of oxycodone, when they intentionally crushed the damned pill!. I have to stop typing. I am getting too angry and my BP is going up. I think I will have a stroke now!

Creating a Market for pain medications on the streets

It sickens me to know that doctors go through 4 to 6 years of medical school ,only to be told they cant prescribe certain medications.
Or they are scared to death of prescribing opioiods to the people who need them the most, all people in chronic pain.

When Pain Specialist can no longer prescribe opioiods ,then there is a need for them ,therefore causing them to be sold illegally.
When there is a need for a drug and it can not be prescribed then the drug dealers see a need for it and next thing you know the streets are the next place to go to find pain relief.Don't the DEA know their causing this to happen by harassing our doctors that treat pain.

If they would just leave our doctors alone and let them do their job at helping those that suffer in chronic pain there would be less need for pain medications on the streets.Is that so hard to figure out.
When will our government wise up and leave our doctors alone.
People who suffer every day in pain will find relief one way or another,no one wants to suffer,but what's happening now is the DEA is creating a market for illegal drugs by withholding them from the people who need them the most.,people who suffer every day in Chronic pain.

DARVON

Darvon is a notoriously ineffective painkiller. In an hour-long conversation with a DEA pharmacologist, I learned that shortly after Darvon went on the market, in the late 50s I believe, it was found to cause seizures and fatal heart arrhythmia when taken in excess of a very low dose (six 65mg pills taken at once). It should, she said, have been taken off the market immediately, but instead was moved a step up and changed from Rx to a Class 4 or 5 narcotic.

The reason? Elli Lilly, which held the patent. Who was one of Lilly's biggest shareholders at the time?
George Herbert Walker Bush.

And that information direct from the DEA.

You can't tell me that politics doesn't influence your health.

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