FDA Pulls Darvon and Darvocet From the Market

By Karen Lee Richards, Health Guide Wednesday, November 24, 2010
Last Friday the FDA announced that Xanodyne Pharmaceuticals had agreed to withdraw propoxyphene – better known by the brand names Darvon and Darvocet – from the U.S. market due to new data showing that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. ...
Fibromyalgia Flares & Stress Factors such as Overcoming Feelings of Loss
Lene Andersen, Health Guide
11/24/10 8:01pm

I felt a long rant building, but then decided not to. It just makes me too tired.

 

You're absolutely right - withdrawing medication that has worked well for people for FIFTY YEARS based on the results of a study with 18 participants it is not only ridiculous, but also scientifically unsound. The appropriate decision is to initiate more studies with a statistically significant sample size and in the meantime, urge caution in prescribing the drugs. it's the War on Drugs again becoming the War on Pain Patients.

 

And if you'll excuse me, I'll go bang my head against the wall.

11/24/10 9:11pm

I'm right there with you, Lene. (sigh)

 

Dana

11/24/10 10:48pm

"Fear and follow-the-leader" it has been many years that I heard that it was coming, maybe then they did not have enough guts to do it but now with the fear of "drugs" ... My poor mom had terrible pain for years she finally got darvon and had a little relief because she was "undermedicamented". her mysterious disease was hard to believe then. Now I know she has fibromyalgia and co. as my gr-mother before and me thereafter . It was called the family muscle arthritis in a lack of a better name. You are right it has been on the market for over 50 years so many migraine sufferers were helped by it. I did take darvocet with good results then. I am so afraid that this other one out of the way is opening the way to banned other ones, mind you some are more dangerous as Karen mentioned it.  

11/25/10 5:30pm

I found it very interesting and unsettling that the FDA recalled this drug with so little research. As a nurse practitioner working in the field of cardiology for the last 11 years, I have not seen one person with the mentioned deadly side effects. I have however seen this drug work for many people, including myself.

As a prescriber and as a patient, I would like to see the FDA spend more time researching drugs they recall instead of jumping to conclusions with a small group of "researched" people.

 

V, Health Guide
11/26/10 8:00am

I'll just say this makes no sense to me, but then I am a pretty logical person, and the FDA doesn't seem too logical lately. I wonder if anyone on the FDA board that decided these drugs should be withdrawn from the market suffers from any chronic pain...

11/26/10 10:52pm

Maybe not but they perhasp  know someone who know someone who abused darvon and others,   that's the only solution for them  to fix the problem, we don't count for these people. I had someone telling me that if there is so much drug in the street it because of people who get them by Rx........Better, because of old retired ple who sell them @#$%^& to pay tthemselves a trip in the sunny places.

Ignorance and lack of empathy.   

V, Health Guide
11/27/10 7:50am

Oh, my!  I would not know how to respond to that kind of comment. Did you bother to answer that person, or just walk away?  Probably wouldn't do any good to address the issue. Hard to change a persons mind who has no idea of what is like to live in chronic pain.   That is one of the most ignorant, harsh statements I have ever heard/read.   I am still shaking my head.  Sealed   Peace, V

11/28/10 8:14pm

I have been taking Darvocet for 10 years. It is the only medication that worked well enough to take the edge off my pain without knocking me out, or severe allergic reaction.

 

I learned about the recall a few days ago when I went to pick up my refill. I was taking 6 tablets a day, no they cut me off completely. The on-call Dr. put me on Ultram which does nothing for the pain or the withdrawal symptoms. I am sick, and desperate. How can the FDA justify just yanking it off the market without Physicians being notified and given time to aid patients through withdrawal or slowly take them off as they put them on another medication. I can not function and am hating life right now.

Karen Lee Richards, Health Guide
11/28/10 8:31pm

I couldn't agree with you more.  It is cruel to just cut patients off suddenly with a medication that can cause withdrawal.  Actually, the FDA recommended that patients stop taking Darvon immediately, which I personally think is ridiculous.  People have been taking it for 53 years.  I wouldn't think at least a few more weeks to stop gradually and avoid withdrawal would be reasonable. 

 

Dr. John Claude Krusz, our medical advisor here on ChronicPainConnection, has had good success using Zanaflex to help his patients who are going through withdrawal.  You might talk with your doctor about the possibility of prescribing Zanaflex for you until you get through the withdrawal period. 

 

I'm so sorry you're having to go through this.  I hope you and your doctor are able to find another option to help ease your pain.

11/28/10 10:42pm

I'm also going through withdrawal...how long does it take to get through it? Ultram does nothing for me and I'm allergic to oxycodone, hydrocodone and morphine...really doesnt leave any options...very frustrating. If anyone knows of an alternative I would love to know!

Karen Lee Richards, Health Guide
11/28/10 11:25pm

I've been searching for an answer to how long Darvon withdrawal symptoms last.  No one seems to have a definitive answer because it apparently varies from person to person based on many factors such as dosage, how long you've taken it, your metabolism, etc.  They do say the most severe withdrawal symptoms occur during the first several days after discontinuing use.  I'm sorry I couldn't find anything more helpful.

 

As for other medications you might be able to take... have you tried codeine?  If that doesn't help or you can't take it, the only other thing I can think of is to talk with your doctor about methadone.  Darvon and methadone are "chemical cousins" so if Darvon worked for you, maybe methadone would, too. 

 

Good luck!  I hope you find something that will help soon.

11/29/10 9:10am

Thank you Karen. I'm going to the dr today and wondered about codeine and methadone. Also in doing some research I came across a drug called Levorphanol that seems to be a synthetic medicine maybe not something I would react to with the hydrocodone, oxycodone and morphine allergies. Anyone familiar with it?

Anonymous
Rebel with a Cause
11/30/10 9:53am

Well, now what do I do for pain??  I am allergic to all other pain medications and Darvocet is the only one I can take.  I suffer from Fibromyalgia, Depression, Peripheral Neuropathy, Migraines, Neck and Shoulder Pain and this is the only medication I can take and it's the only medication that works for me.  When I recently suffered a broken foot, that was all I could take for the extreme pain.

 

Now what do I do???  Why didn't the FDA do a test on me where heart problems run in my family???  I don't have any heart problems and I have been on this medication for years.

 

 Rebel with a Cause

11/30/10 7:21pm

I used to use Darvocet effectively to help relieve my Fibromyalgia pain at night. I had to stop using it and all other narcotic pain medications because I developed serious allergies to them. this study appears to be woefully lacking in scientific rigor. 18 subjects? that is not enough subjects to verify any data! What I don't understand is why more information on this board does not deal with the medications like zomig, Maxalt and Imitrex which very successfully abort a migraine fairly quickly and with no side effects. Why be miserable when there is an instant abortifacient out there which will relieve your pain possibly 15 to 30 minutes. You do your readers a disservice.

11/30/10 10:08pm

There is a board for migraine you will find on Health central .

http://www.healthcentral.com/migraine/find-drug.html?ic=4018

12/ 1/10 3:05pm

i know maxalt works very well  but do you know how much it costs!!!  i think i got 9 tablets for about $260.00 verses $13.00 for 90 darvocet. 

 

12/ 1/10 11:55pm

Imitrex has a generic now so it is very cheap. I am fortunate that I have insurance and I only have to pay a copay but even the copay is not cheap. I prefer Maxalt and Zomig  but I am using generic Imitrex because it is cheap.

12/ 1/10 12:56pm

what are the chances this drug might be back on the market.  

Karen Lee Richards, Health Guide
12/ 1/10 2:28pm

I'm afraid there is very little chance Darvon/Darvocet will ever be back on the market.  Technically, there are many other pain relief options available, so the FDA doesn't see a need for it. Their decision seems to be supported by many physicians according to this MedPage Today article:  Clinicians Say They Won't Miss Darvon

 

Unfortunately, for some patients, the other options don't seem to work as well. 

12/ 2/10 12:48pm

I agree with you completely. My wife has severe osteoarthritis im most of her joints, and two Darvocet-N 100 a day has been the only thing that gives her any relief. She has tried all the NSAID's, and currently on diclofenac, but only gets relief with Darvocet-N 100 added to it. . She has taken this since it first came out and has not had a problem with it. She takes many other medications that are detoxified in the liver, so she has lab tests routinely to check for any problems. I have been a registered Pharmacist since 1956, and have also dispensed a lot of propyxophene products. A study of 18 people is not a study at all. You're right that the FDA requires many more in the studikes to approve a product, taken over many years. Any problems with these products has been overuse or misuse  and probably invcolves cases where many other medications, including illegal ones are being taken along with them. In our case, We don't know where to turn for her for relief now because whe has tried most regimens. I am retired, but am receiving questions from friends who will also be affected by this withdrawl the same as my wife. They've taken a very valuable product from many patients because of the carelessness of a few.

 

12/ 2/10 3:49pm

I too am very upset with Darvocet being pulled.  It is the only pain medication I can take, other than Ultram which does nothing.  I used it through three cervical spinal fusions from 2002-2006.  Now I just recently had two lumbar surgeries a week apart and was given Darvocet N 100 again, because I told them it works for me and that I have severe reactions to Percocet and Vicodin.  I used the last of my Darvocet last week and am in noticeably more pain now that I don't have it to take.  I too was told to use Ultram....it again is doing nothing!!!!

 

WHAT ARE ALL US SUFFERERS TO DO!!!!!?????FrownCry

12/ 3/10 12:33pm

this websites that say they sell generic darvocet are they for real.   

 

 

12/ 3/10 12:56pm

also i just wanted to know if anyone from the famous FDA reads any of these comments considering so many people are so concerned.  not that they probably really care about us.  if we read any medications side effects we would be scared to take anything.  i dont want to take any thing stronger.  is there anything we could do  or anyone can do..  HELP

12/ 3/10 3:04pm

Which website are you referring to? I called a compounding pharmacy and they said they could no longer make anything like darvocet. The kicker of it is...there is alot of darvocet just sitting on pharmacists shelves and in the hospitals. I have so many allergies and am now taking tylenol 3..doesnt do much and it makes me itch..fun stuff. wish the FDA knew how hard this is for us! Im considering Levorphanol because its made different but the manufacturer runs out at times. It is a medicine that can be compounded though. Wish I knew if anyone has tried it?

12/10/10 10:06am

It was time to refil my prescription and when I called the pharmacy the day after Thanksgiving, I was told the FDA had taken it off the market. What am I supposed to do now? I have severe fibromyalgia, lypo-lymphedema, arthritis and a host of other health problems. In the last 8 yrs, I have gone through 3 rheumatologists, and a pain clinic where the dr. is guilty of medicare fraud and will be caught soon, I have no doubt, and now Im back where I started with my internist. I have been weaning off the drug and each day the pain is becoming unbearable. I understand why they took it off the market. I too have had heart palpatations since I started taking darvocet and even went into congestive heart failure 2 years ago. I simply need someone to tell us what to substitute.

2/ 4/11 3:03pm

I don't believe there is anything comparable to Darvocet/Darvon.  I have taken it for 3 decades and it is the ONLY thing that works.  I didn't take it everyday, only when really necessary.  I have known so many people that have used it with no problems.  Over the years the Dr. has given me other things to try and nothing (not even the stronger drugs), works!  I will never believe that it is anything but greed.  There are all these new drugs (which by the way many of them have a possible side affect of DEATH), that are very expensive and that's where the problem lies.  I don't have insurance and a bottle of 100 Darvocet cost $82.00, which is even much less than even some of the over the counter drugs. THERE IS NO MONEY TO BE MADE OFF DARVOCET and they had to open up the market for some of the more expensive drugs that are being pushed by the drug companies. I'm really tired of the government deciding what is best for me. My Dr. gave me a new prescription today and told me to try them, it's called Nucynta.  I won't be getting it filled though because I just found out that it cost over well  over $300.00!!  Thank you FDA for doing that extensive study with 18 people.....I'm sure they are a great representation of the thousands of people that have taken this drug with great results for over 50 years! 

3/ 1/11 10:08am

I have taken Darvon for years and found it to be great product that stops the pain other drugs won't touch (Ultram) without giving a euphoric or stoned feeling of the stronger opiats. I AM SO SICK of this damned government butting into EVERY aspect of our lives!  First it was the switch to dig TV (which I can't recieve well). Then it was Incandecesnt light bulbs (Which I use extensively to heat pet houses and water pipes in winter) ( the flourecents are loaded with Mercury). NOW it's my pain medication AND what I grow inmy garden!  Has anyone tried to buy "strike anywhere" matches lately? (yea... them too). The list grows daily. Time for revolution.

4/ 5/11 7:43pm

This is an outrage! I am not able to take anything containing codeine - since it builds up in my system and makes me toxic. Tramadol affects me exactly the same way. The violent vomiting and catatonic state it puts me in just adds to my pain and leaves me unable to even call out for help.

 

I have a chronic pain condition and the only thing that works for me is darvocet. I have taken it - carefully so that I will not become addicted or immune to it - for 16 years. It is unacceptable that the FDA can just pull the rug out from under patients like myself with no solid evidence. Right now, I am going thru a flair up and cannot get any relief from NSAIDS. This is preventing me from being able to work.

Anonymous
Mike N
7/17/11 10:20am

How odd that all of these studies stem from "ABUSE" of the drugs, and not adheering to the prescribed dose.  Hell, a cheesburger will cause cardiac damage if you abuse them.... with fries... lol

 

I've lived with cronic pain (RA, Back, Migraine, etc) for years, and through all the different pain medications I've been perscribed, Darvocet has been a lifesaver for me as well.  Even though I was allowed to take up to 3 a day, I rarely took more than 1 a week.  I only took one when the pain was too much to bear.  Pain is just a fact of life, and nothing I've taken since even comes close to the effective qualities in Darvocet.

 

Once again, my quality of life is religated to the trash heep due to a few mis-use loosers and politicians who feel a drastic need to prove their worth by controling what i can and can't do with MY body.  I'm sure that the politicians health insurance, (which allows them to get perscriptions from Canadin pharmacies) would allow those who write the laws, to continuously cercomnavigate the decisions that they've made on our behalf, to get the medication that they know works for them....

 

Mike N.

Austin TX

07162011

Anonymous
CherylAnne
1/ 4/12 1:17am

I have taken darvocet for many years for various pain conditions with no side effects whatsoever. It has been the only narcotic pain killer that I can take due to my overly sensitive system to drugs. I was recently injured in a fall, breaking 2 ribs and injuring my back. Darvocet has been the only thing that has given me any relief from the rib and upper back pain that I suffer from. Now, I am squandering my last few pills and wondering what I will do when those last few pills are gone. Why didn't they just black box it so we could take it at our own risk? That removes their liability and still gives us our much needed pain relief. In my opinion, the drug companies just want to push the "new generation" pain killers at us to put more money in their own pockets. Thanks, FDA, for putting so many of us back in agonizing pain based on a study of 18 people,..thanks alot !!

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By Karen Lee Richards, Health Guide— Last Modified: 01/04/12, First Published: 11/24/10