Substitute For Darvocet (Page 2)

Updated

My Dad is taking Tramadol in place of Darvocet. He took Darvocet for 20 years no side effects, now he is taking Tramadol and is good for pain but his blood pressure is going high and he has arrythmia and terrible depression. I think this pill has problem working with Paxil, Atenolol, Norvasc and Digoxin and should not be given together or adjusted. Why are doctors not aware of this and what else could he or should he be taking? Confused and upset! I f Darvocet cause heart attacks then why could he take it for 20 years without problems and now with Tramadol the safe one he's having all these troubles.

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21

I agree. I have rx's not good for stomach but still prescribed. Darvocet worked great without issues. In pain every day need something better than trampoline. Probably a money thing.

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22

McNeil must own the FDA, banning darvon/darvocet/sk65 whatever, which gave me quality of life and not one single side effect....ver, but acetaminophen which is the #1 cause of acute liver failure in this country, is not only legal...its in everything! no wonder there were all the tylenol murders in the....what was it? the 70's....anyway tylenol NEEDS to be banned, stop buying it, but it has become such a trusted family liver toxin people wont listen, like the fda, they are responsible for so much death, but money is the factor isn't it. How hard would i be, for an experienced chemist to just make it, to hell w/ fda, its gotta be available somewhere in the world. THNX 4 THE Poison fda, u took darvon off the market cuz it worked, and had aged in the face of all the nightmare toxins (new kids on the block and billions of $$$) were not all stupid americans, TAKE OUR COUNTRY BACK!!! BAN THE FDA!!!!

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23

I still have a half a bottle of darvocet I itch on all other pain pills but darvocet and I severe back pain so when I'm at my worst I take it they need to bring it back had darvocet in my 20s I'm 58 now don't have any heart problems all pills have causes of this and that I need my darvocet and when I'm out I'll have to and my life I'm that bad

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24

I'm giving up a LOT of very precios time I have left to do just that...BUT I CANNOT GET ANY ORGANIZED Solidarity behind me!!!!

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25

well dammit that didn't work out right and I misspelled precious, bad day....bad millinium...anywy, I am a staunch supporter of propoxyphene, whether it be darvon darvocet (anyone know what the n stood for? My mother took this medication for 50 damn years, i took it for 20, while I was on it and it alone...my life flourished, I never developed a tolerance, nvr increased my dosage, darvon did something in my brain that made something that wasn't working...work, it was a miracle drug for me and they...outlaw it, PERFECT!!! nvr mind the liver toxin that is in nearly every damn thing there is,(acetaminophen) Ever hear of levo dromoran? same story, but the FDA allows a drug on the market that was so dangerous, the manufacturer took it off b4 the FDA noticed a thing...VIOXX, that s*** nearly killed me and has destroyed my life...FDA...stick w/ food, and let the people be? we're not stupid and we're fed up, you ppl are ALL ABOUT MONEY- f*** the "war" on drugs...btw, the most costly war ever in history. Stick w/ methadone and leave our dr.s alone. Believe it or not, not everyone who doesn't have a choice, is a drug addict, chronic pain=drug addict=risk=licence=all my money, f*** 'em...after all if they're in that much pain they'll end it themselves and we won't be bothered..problem solved, we get 'em coming and going, lets not forget who invented opium and marijuana in the first place, it damn sure wasn't you.

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26

The FDA was sucked into taking this ludicrous decision to ban propoxyphene (Darvon) on the seriously flawed report by UK's MHRA!

MHRA DEFINITELY NOT FIT FOR PURPOSE

Decisions taken by MHRA regarding Co-proxamol could only be described as farcical if the results for patients hadn’t been so horrendous!

Four years after their ban on co-proxamol they continued to search for reasons to justify their irrational reasoning for banning co-proxamol.

I have been led to believe this Xanodyne trial, commissioned by the FDA in late 2009- 2010 to ascertain the possible consequences of increasing doses of dextropropoxyphene on cardiac function. This followed the FDA’s refusal to accept the Public Plea to ban it.

They gave healthy 25 - 45yr old volunteers daily doses of 600 mg (2.31 times the max UK dose) & 900mg. (3.46 times the max UK dose). After 11 days they had to stop the trial as some of the volunteers developed serious & potentially fatal cardiac arrhythmia's.

The FDA's / Xanodyne Pharmaceuticals cardiac conduction testing was performed with extremely high daily doses of Dextropropoxyphene! While Co-proxamol, contains only 32.5mg/maximum 8 tabs/day which only amounts to 260mg/day!

The USA equivalent ‘Darvon’ has a usual dosage of one 65 mg propoxyphene hydro-chloride capsule every 4 hours 6 tablets per day. The maximum daily dose is 390mg which was still significantly higher than the UK maximum dose.

Reference: - https:/­/­www.gov.uk/­drug-safety-update/­-dextro-propoxyphene-new-studies-confirm-cardiac-risks

You can clearly see from my WordPress blog the [BBC Breakfast video Part 3] (August 2008) MHRA’s Dr. June Raine quoting “just a few tablets too many” could cause accidental death!

https:/­/­coproxamolban.wordpress.com/­2016/­02/­18/­co-proxamol/­

THIS FDA REPORT APPEARS TO BE ABSOLUTE NONSENSE, AS THE MAXIMUM UK DOSE WOULD BE 8 TABLETS PER DAY WHILE FDA’S MAXIMUM TRIAL DOSE WOULD HAVE BEEN OVER 27 TABLETS!

The MHRA (via .gov.uk) APPEAR TO HAVE BEEN SCRAPING THE BARREL IN ORDER TO JUSTIFY THE INHUMANE DECISION TAKEN BY THEM DURING 2005!

THEIR CATASTROPHIC DECISION HAS RESULTED IN WORLDWIDE MISERY! THIS MHRA INITIATIVE FIRST INFLUENCED DECISIONS TAKEN BY THE EUROPEAN MEDICINES AGENCY DURING AUGUST 2009 WHEN THEY DECIDED TO WITHDRAW CO-PROXAMOL. THIS WAS FOLLOWED BY THE US FDA WHO TOOK ACTION IN 2010. THIS RESULTED IN CANADA, SINGAPORE, TAIWAN, AND NEW ZEALAND TO FOLLOW THE SAME PATH.

Since November 2015 the NHS via local CCG’s are now determined to stamp out the 'Named Patient safeguard' guaranteed by MHRA during (2004 – 2007), whilst hoping the real reason for the price rise isn't blamed on them! This decision will result in thousands of patients living in unmedicated pain for the rest of their lives.

WHY? (A total lack of foresight)!

The ‘Australian Acute Musculoskeletal Pain Guideline’ WAS RESCINDED BY NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL IN 2013.

Australia 2013 The Administrative Appeals Tribunal (AAT) reversed the decision took in 2011 to ban the drug and CONCLUDED THAT THE QUALITY, SAFETY, AND EFFICACY OF DI-GESIC AND DOLOXENE (CO-PROXAMOL) WERE NOT UNACCEPTABLE, PROVIDED THAT ADDITIONAL CONDITIONS AND MONITORING ARRANGEMENTS WERE IMPOSED. The drug is now available for prescribing again. Reference: - http:/­/­www.medicine.ox.ac.uk/­bandolier/­b...

Reference: - http:/­/­www.nhmrc.gov.au/­_files_nhmrc/­pub...

MHRA (OR DEPARTMENT OF HEALTH) HAVE FAILED TO WORK WITH THE MANUFACTURER to ensure the unlicensed product remained available! The Department of Health has been negligent by not ensuring a consistent supply of Dextropropoxyphene in order to enable the ‘Named Patient Scheme’ to continue. Whereas Aspen Pharmacare Australia appears to have had the foresight to purchase 99% of the remaining stock during 2013 in order to supply the needs of the Australian patients for the foreseeable future!

The inept decisions taken by the MHRA in 2005 has caused worldwide disruption in the manufacture of Dextropropoxyphene which is the main cause of the spiralling costs of Co-proxamol today.

Global manufacture of dextropropoxyphene has followed a downward trend since 2003, when 349.6 tons were manufactured. (Actual cost to NHS less than £2.00 per 100 Tablets) This decline is attributed to the fact that the substance had been banned in several countries owing to concerns over serious side effects.

In May 2013, the Ministry of Health and Family Welfare of India issued a gazette notification suspending the manufacture, sale, and distribution of dextropropoxyphene and formulations containing dextropropoxyphene in the country. Manufacturing therefore declined again, to 135 tons in 2013.

Despite the suspension measure, India was the only country reporting manufacture in significant quantities in 2013. Global exports also continued to decline in 2013 and amounted to just 199 kg, almost exclusively from India, the principal exporting country of dextropropoxyphene, with 90 per cent of global exports. The only other country with some export was Cyprus, at 19 kg, or 9.9 per cent. AUSTRALIA IMPORTED ALMOST ALL (99 %) OF THE QUANTITIES AVAILABLE!

Because the deaths involving Tramadol (now a controlled drug) in 2014 were almost identical t () o those of Co-proxamol during 2007 the MHRA appears to have gained absolutely nothing regarding their objective of reducing suicide while causing worldwide misery to millions of patients!

Surely it’s now time to reconsider the fact that Co-proxamol was and is a far superior medication when compared to Tramadol and the manufacture of Dextropropoxyphene must be restarted immediately!

2007 Deaths where co-proxamol was mentioned on death certificates (UK):
242 (Classification De-licenced)

2014 Deaths where Tramadol was mentioned on death certificates (UK):
240 (Classification Controlled)

There is no doubt that more patients would have benefited if Co-proxamol had been given the same “controlled classification back in 2007 and the deaths from co-proxamol poisoning would have continued to fall!

Summary

On 15th December 2005 the MHRA stated, “I can confirm that the two most useful references which informed the Working Group on different methods of analgesia were the 'Bandolier review' and the 'Australian Acute Musculoskeletal Pain Guideline.” (Later rescinded)

Example of Bandolier: -

‘Bandolier’ tries to find examples of systematic reviews where there is a solid take-home message. After all, we are familiar with uncertainty, and systematic reviews that merely bleat, often inadequately, about inadequacies of research are rather depressing. The trouble is that people use phrases like 'evidence-based medicine', or 'meta-analysis' or 'systematic review' as some form of talisman. Attach one of these phrases to a point of view and an argument is won!

That fails to take into account the fact that reviews can be awful, and even completely wrong. Often systematic reviews try to cover too much ground, and end giving us too superficial a view of a problem. And even the best of reviews of good studies can leave us in the lurch when there are not enough good studies.

Reference: - http:/­/­www.medicine.ox.ac.uk/­bandolier/­b.

“GPs demanded a U-turn on the co-proxamol ban.” The magazine (Pulse) reported its own survey, which showed that 70 per cent of GP's and 94 per cent of Rheumatologists demanded that the MHRA revisit its decision. THEIR REQUEST WAS TOTALLY IGNORED.

My Personal Opinion “The Truth Was Out There”

Despite my best efforts there appears to have been no cohesion at all between the NHS departments, MMG’s CCG’s DOH, MHRA, ACMD, or the Home Office.

I've previously contacted these departments the APPG Secretariat and many of the organisations who originally disputed the MHRA’s decision to remove the licence for Co-proxamol at the end of 2007. My MP Paul Maynard answered my request by simply quoting the misinformation from MHRA and declined my request for a meeting at one of his surgeries. I've also submitted several ‘Freedom of Information’ requests since my prescription for co-proxamol was cancelled during November 2015.

Despite all the false information being distributed from all the Government departments I have contacted the simple truth was: - BECAUSE OF THE COMPLETE INCOMPETENCE OF THE MHRA / DEPARTMENT OF HEALTH THERE WAS INSUFFICIENT SUPPLIES OF DEXTROPROPOXYPHENE AVAILABLE (WORLDWIDE) TO CONTINUE WITH THE REGULAR PRODUCTION OF CO-PROXAMOL!

What has been the financial cost to Government for all the different organisations to dispense all this misinformation? MHRA should just admit they were totally responsible for this ‘ALMIGHTY COCK UP’ and apologise to the millions of patients they have left in complete misery and caused them serious harm!

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27

I had a neck injury from work 7 yrs. ago. Terrible pain and still have alot of trouble. I would take Darvocet only when needed and could atleast function. Dr. switched me to tramadol. Ha what a joke! It does absolutely NOTHING for my pain. It's like taking a P!acebo. I don't know what to do. It seems like the doctor's hands are tied. I need something besides this worthless Tamadol!

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28

I'm am suffering in pain. oxycodone (18x stronger than hydrocodone) wears off after 40 minutes, same for hydrocodone,: within 40 minutes my pain returns , it was never turned off. It went from a level 10 in severe pain, down to a level 2 , then back to a level 6 at 40 minutes. Its one hour later I am back to a 10 severe pain. I had dentalbone surgery. Why the h did the fda take darvocet away? I used darvocet for my impacted wisdom teeth removal 30 years ago. It would turn off the pain and let me sleep. I want to chisel and take a mallet to the a- holes that came up with this pea brained idea to remove darvocet from patient care. I want to extract all their teeth with chisels and mallets and give them no medicine . Because they need to feel as I do!

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29

Omg I feel your pain. I bet you can get Darvocet in Africa or India, or Mexico. Not here, we have very cruel government control.

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30

I used to take Darvocet all the time for my fibromyalgia and it worked like a dream! So, When I was to renew it of course it was discontinued witmy asmazment! They put me on Tramadol which worked for a while but as time it quit working and now I'm left with other pain meds that doesn't work!!!!!!

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31

I'm one of the few remaining patients fighting for the UK Government to reinstate licences for Co-proxamol (Darvoet) and recently discovered that the most likely reason for the removal of the ‘Marketing Authorizations’ was probably financial.

In a report which was conducted by the FDA between 1969 and 2005. It would appear that the FDA had completely ignored their own published information. The report clearly shows that the two drugs (Oxycodone & Tramadol) which the FDA and MHRA have continued to grant additional ‘Marketing Authorizations’ for had the most adverse event reports from patients, and the drugs had been proven to be more harmful and addictive.

As Co-proxamol had been on the market for over 50 years the income MHRA (UK) received from the remaining 17 ‘Marketing Authorization’ holders had diminished by 2005.

MHRA have issued many more ‘Marketing Authorizations’ during the period from 2005 to 2014. Once again they appear to seek increases in their income while totally ignoring patient safety & wellbeing.

MONETARY IMPACT OF CO-PROXAMOL WITHDRAWAL

My Questions for MHRA: - Co-proxamol what was the monetary loss to MHRA when these MA’s were cancelled?

MHRA response: - Zero

What was the potential monetary loss to MHRA between 2008 and 2015? (Renewals Etc.)

MHRA response: - This has been calculated to be approximately £100,000

Alternative Analgesia

How many MA’s were held for OXYCODONE drugs when the phased withdrawal for Co-proxamol was first announced in January 2005? - 13

How many MA’s were held in January 2015? - 151

What was the monetary Gain to MHRA between 2008 and 2015 resulting from any increases in the number of MA's issued? (Including Renewals Etc.). Approximately £1,550,000. This is the total received in application fees for these new marketing authorizations and does not include any subsequent licence variations or service fees.

MHRA, In reply to your comments, medicine licensing fees vary depending on the complexity of the application and in the case of these oxycodone products, the initial fees for each product varied from £2,700 to £29,000. In addition every product will have a different history of variations to the licence (most variations will also incur a fee and these also vary considerably depending on the complexity of the changes being requested) and the volume of periodic fees may also differ, depending on whether a licence remained active or was cancelled during this period. We estimated that it would take at least 15 minutes to check the records for each licence and produce an estimate which is why we exempted this information under Section 12 of the Freedom of Information Act. The figure for loss following the co-proxamol cancellations was simpler to estimate because no initial fees were involved.

*Copyright notice. The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell, or otherwise use any information provided without prior agreement from the copyright holder

Deaths in the UK from all of the alternate analgesia have increased alarmingly since the MA’s for Co-proxamol were removed!

• Deaths from Tramadol rose from 53 in 2005 to 240 in 2014
• Deaths from Oxycodone rose from 11 in 2005 to 53 in 2014
• Deaths from Codeine rose from 44 in 2005 to 136 in 2014
• Deaths from Fentanyl rose from 3 in 2005 to 40 in 2014
• Deaths from Buprenorphine rose from 5 in 2005 to 24 in 2014
• THE ONLY BENEFIT OF BANNING CO-PROXAMOL HAS BEEN THE MANY MILLIONS OF POUNDS ADDED TO THE COFFERS OF MHRA!

None of the 1.75 million patients prescribed Co-proxamol were consulted in the CSM/MHRA review!

Their reasoning for the removing of the MA’s: - 300-400 deaths per year. DEATHS FROM THE ALTERNATE DRUGS HAVE INCREASED MORE!

There have been significant financial gains for MHRA with the additional Marketing Authorisations (MA’s) being issued by them. Unfortunately this has seriously impacted on the 1.75 million patients in the UK who were receiving prescriptions prior to 2005. Their decisions have been directly responsible for the increased death rates with the alternate drugs on offer!

When the decision to remove the licence there were approximately 1.7 million patients taking Co-proxamol in the UK; the overdose death rate, even if their figures had been correct equated to just 0.02% OF PATIENTS WOULD HAVE BEEN AT RISK of death (intentional or accidental)!

The vast majority of patients had taken Co-proxamol responsibly and, in normal use, CO-PROXAMOL POSED NO THREAT TO LIFE AND HAD CONSIDERABLY FEWER SIDE EFFECTS THAN ANY OTHER PAIN KILLING DRUG.

The FDA and MHRA have deliberately removed a completely safe (when tolerated and used correctly) drug from the market while continuing to grant ‘Marketing Authorizations’ for two drugs which were known to have serious consequences for patients.

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32

Gosh, I was just checking out Darvon hoping I would b able to request it from my dr. I did not know it was taken off the market. My mom used both Darvon & darvocet for 40 some yrs for her R.A. pain, no problems at all. Darvon was the only thing that took away my neck & migraine pain. Nothing out now a days stays working & the feds have the drs. afraid to give u what u need. U R ready to bite the bullet as u just cant take it any more, no quality of life.

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33

Most of the problem is this ridiculous war on drugs, they have failed to even make a dent... in fact since "the war on drugs" started....Very illegal drug use has skyrocketed, but they will never be able to tell ppl what they should and shouldn't do when it comes to OUR lives and making OUR choices about the manner in which we live it. Darvon was an absolute miracle drug for me, I nvr had 1 single side effect, but the money men (corporate america) needed to get it out of the way somehow, b/c this stupid war on drugs was a goldmine and they knew it...Darvon was SO effective and dirt cheap, Dr's, if they were going to give you a mild narcotic (there was a split among dr's as to whether the drug was even a narcotic at all) if they had to make a choice propoxyphene was considered the safest, But w/ the "war on drugs" there was a brand new government inspired "demand" for pharmaceutical companies to come up w/pain drugs (why did it have to be pain? couldn't it have been ritalin or something) that were 100% non narcotic, and the FDA pushed Dr's to prescribe these drugs instead of those evil, downfall of America, EFFECTIVE "narcotics" Controlling drugs like darvon is them controlling YOU...darvon never ever caused me, my mother, my mothers friends, anyone I knew that took it in fact, a single side effect and I took it for over 25 years, I get put on Vioxx (thanks fda) and wound up in ccu....kidney failure/stroke/encephalitis/brain bleeds all over the place...the consensus in the hospital, Poisoning! but since they hadn't "discovered" how dangerous the drug was at the time...it was labeled a "toxic event"... and still has not healed after 15yrs (developed CRPS) So welcome to the new world...they'd rather kill you, then you "feel good/better". This is all about money and the FDA/DEA and our multi-millionaire (billionaire) federal "babysitters"....You guy's can't even stop crank...so you wanna go after people, Dr's, all the way down to nursing homes and the elderly or the victims of a painful disease, buuut we all know you all have GREAT gov't jobs, you have a budget you must spend to get "more" so you can keep your jobs and your worthless "agencies" in some kind of artificial "need" to exist. HELLO WE DO NOT NEED A BABYSITTER AND WE DON'T NEED NOR WANT YOU! Welcome to "corporate" America... Americans.

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34

I agree this was one of the best pain meds out there, I took it for 40 yrs for my pain and NEVER had side affects, never was groggy from it either. I just dont think they made enough money from it. SHAME ON THE FDA

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35

I agree - let the people speck regarding this wonderful drug. Back pain, I is a hard thing to live with and I'd you cannot take NSAIDs because of high blood pressure,
Dar on does the trick with no side effects for me also...
FDA get a clue...grow up ... as long as the drug is used appropriately if have values or pain relief.
Better than opioids, drugs overdoses and narcissism to save lives. F D A strop controlling people lives!,,,

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36

it's a money thing. darvocet is not very expensive and drug companies could not make money off of it, so they came up with a bad side effect after all the years people have taken it with no probably. I have not found a pain medicine I can take since it was taken off the market because they all cause bad headaches, especially that tramadol. I suffer pretty bad with all the spinal problems I have since they took darvocet off the market. I only took it when the pain was really, really bad and I really suffer bad some days for days at a time. I cannot take most NSAIDS because they take too much fluid out of my joints and cause really bad pain in my hips. I have had some really bad cervical pain lately & have eaten tylenol like candy and I am very surprised I have not had liver failure.

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37

There have been reports that there is a political movement to increase deaths in the category of serious pain patients to decrease medical costs across the board. There also are possible activities by this movement to increase the amount of dangerous substances in street drugs as well as add toxins to various forms of imported alcohol, bacteria to imported cannabis and tobacco. Some of these may just be pipe dreams of some strange think tanks involving extremist viewpoints, but they are scary concepts that might explain a lot. Do searches in this area and tell me if you agree that something is foul!

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38

Very interesting. Going out on a limb here - have noticed that the number of doctors being murdered by patients has skyrocketed since the war on pain killers began. Very strange times, top of list murdered are doctors treating pain and oddly enough psychiatrists.

Also have been told but is hard to prove that the reason Darvocet was actually removed was because an underground operation found a way to chemically convert it into a much more powerful drug.

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39

I took it that long too, my dr. Told me one person had one and they blamed it on that, I think its because it was cheap and worked great.

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40

See your warning about new substances in opiod street drugs, to think this may be intentional, but saw deaths in Georgia from some new opiods. Political movements need to be reasonable or we are in a real mess!

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