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Darvocet is dangerous in the U.K., but not the U.S.?

June 19, 2008 by Frank Rogers

If the British recognize that the drug propoxyphene is too dangerous to prescribe to patients, what’s keeping Americans from realizing the same thing?

The U.K. began a phased withdrawal of Darvocet, which contains propoxyphene, from the British market in 2005, after the U.K. Committee on Safety of Medicines recommended that they do so. In its report, the CSM stated that it could not “identify any patient group in whom the risk-benefit [ratio] may be positive.” The withdrawal was completed at the end of 2007.

It’s not that Americans haven’t tried to tell the government to pull propoxyphene off drug store shelves. In 2006, Public Citizen petitioned the U.S. Food and Drug Administration to withdraw all drugs containing propoxyphene, including Darvon and Darvocet, from the market because of the drug’s hazardous side effects. However, the FDA still has not granted or denied the petition. So now Public Citizen is filing a complaint in the D.C. District Court in the District of Columbia asking it to compel the FDA to make a decision.

Propoxyphene is an extremely dangerous painkiller. It is physically and psychologically addictive, is no more effective than safer alternatives and has been associated with more than 2,000 accidental deaths in America since 1981. Despite these risks, however, the drug was one of the 25 most prescribed generic drugs last year, with 22 million prescriptions filled in pharmacies in 2007.

Reports on propoxyphene dosage suggest addiction can occur at less than the maximum recommended daily dose and unequivocally confirm addiction at just twice the recommended daily dose. In addition, propoxyphene has been deemed inappropriate for the elderly because of its adverse effects on the central nervous system – such as sedation and confusion – that have been found to increase the likelihood of falls and fall-related fractures. However, studies have shown that propoxyphene use is widespread in emergency rooms, institutionalized populations and retirement communities.

Public Citizen is asking the court to find that the FDA’s delay in ruling on the 2006 petition is unlawful and to order the FDA to issue a decision on the petition. With substitutes for the drug that are equally effective and far less hazardous, the FDA has no reason not to immediately start phasing out propoxyphene from American drug stores.

Go to the Public Citizen Web site to learn more about this case. Also, Public Citizen’s WorstPills.org provides information about Darvon, Darvocet and other dangerous drugs.

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Posted in Consumer Protection, Health, Pharmaceuticals, Product Safety | 3 Comments

3 Responses

  1. on June 25, 2008 at 4:52 pm Linda Schenk

    I am allergic to all narcotics except Darvocet. I am not addicted to the drug, but it is a Godsend to control my pain. You need to leave it on the market for those of us it does benefit. Any drug can kill if abused. Leave us alone. Linda R.N.


  2. on June 30, 2008 at 11:36 am DrJ

    Dear Friend and colleague,

    I hereby send you some results from our reserach in forensic science from The Department of Forensic Medicine at the University of Uppsala in Sweden. Our scientific data are the basis of the message, but we prefer to present the whole thing in a popular science form to get our message out to the public, so called common people, that maybe have lost one loved one due to poisoning to death due to (dextro) Propoxyphene.

    I send you the script to my YouTube-video
    http://www.youtube.com/results?search_query=Jonasson+Darvon&search=Search

    and the link to Wikipedia and Dextropropoxyphene/Propoxyphene

    http://en.wikipedia.org/wiki/Dextropropoxyphene (English version)

    http://sv.wikipedia.org/wiki/Dextropropoxifen (Swedish version)

    More that 2 200 persons have watched the video,

    **************************************************

    This is a message From

    Ulf Jonasson, Doctor of Public Health on YouTube:

    “Darvon, Distalgesic, Co-Proxamol – the worst drugs ever”

    http://www.youtube.com/results?search_query=Jonasson+Darvon&search=Search

    Friends,

    I would like to tell you a story, a very sad story about a painkiller that has been around in the American society since 1957 – that is exactly 50 years. The name of the drug is DARVON or DARVON-N or DARVOCET. It is basically the same drug. In Europe the drug is called DISTALGESIC or CO-PROXAMOL. The working substance in the drug is PROPOXYPHENE or DEXTROPROPOXYPHENE as we call it in Europe.

    We think drugs – containing PROPOXYPHENE – are the worst drugs ever, among prescribed drugs. No single drug in the history has caused so many fatal deaths asthese drugs have done during the last 50 years.

    How come I can sit here and say that? Are you supposed to believe me?

    We – my wife Birgitta and myself – Ulf Jonasson, we are both doctors, PhD:s – have studied the dangers with PROPOXYPHENE since 1993, that is 13-14 years.

    We have written and published 8 scientific articles about PROPOXYPHENE. We have also written and defended two doctorial dissertations about the drug and its fatal consequences. And to get our alarming data outside the academic world, we also wrote a popular science version of our research that was published both in Swedish and in English. The English name of the book is “Fatalities due to use or misuse of painkillers “

    We think we have studied the consequences of using PROPOXYPHENE in a quite proper way, and therefore we will tell this sad story about a drug that probably have killed more people than any drug in the history.

    One of the Big Pharmas in US, Eli Lilly “invented” PROPOXYPHENE in 1953 and it took some years before it came out on the market. There was a need for a painkiller without side effects in the early 50s – and Lilly found PROPOXYPHENE. Have you heard this story before – a drug without side effects???

    The drug was called DARVON – I am sure you have heard about it – and it became immediately very popular. It was not for the pain killing effects the drug became a financial success. Later on, studies showed that the pain killing effect was not better than aspirin or acetaminophen – like Tylenol. The users felt good, because DARVON is an opiate – close to methadone, morphine and heroin – and it influence your brain, you feel good. The drug influences your Central Nervous System.

    As I told you before, we have studied PROPOXYPHENE since 1993. Our main result was that during the investigated years 1992 – 1999 – 8 years – 200 persons in Sweden, were poisoned to death every year due to PROPOXYPHENE – poisoning. 200 persons died every year because they used a very popular painkiller and we thought this was very alarming. Sweden is a quite small country, we have just about 9 million inhabitants. In United States there are soon 300 million inhabitants and we knew, thanks to international statistics, that the American people used even more PROPOXYPHENE that the Swedish people did. Is it therefore possible for us to assume that there is more that 30 times as many fatal deaths in United States as in Sweden.

    Yes, we think so.

    If we look at the consumption of PROPOXYPHENE in United States compared to Sweden, we find some very interesting figures. The average consumption of PROPOXYPHENE in Sweden – during the investigated years 1992-1999 – was 2 400kg/year. In United States you consumed an average of 99 400 kg/year. It is more than 40 times as much in US than in Sweden. Is it possible that the numbers of fataldeaths in US are 40 times more??? What do you think?

    Here are some more figures. We know that consuming 2 400 kg/year in Sweden, caused 200 fatal death every year. You can say that it became “one fatal death for consuming every 12 kilograms” in Sweden. I think you understand and accept the metaphor. How many fatal death could that be if you consumed 99 400 kilogram a year in US??

    The numbers are so high, you will not even think about them. And it gets even worse if you think back 50 years, consuming 80 – 90 – 100 000 kilograms a year in 50 years!!! In 2005 the consumption was 110 040 kg.

    I will also mention some figures about the PROPOXYPHENE-situation in United Kingdom. They have also had huge problems with fatal poisonings due to PROPOXYPHENE. In the year 2004, some 1,5 million persons got 7,5 million prescriptions on their version of PROPOXYPHENE, namely CO-PROXAMOL. These 7,5 million prescriptions became more than 900 000 000 CO-PROXAMOL pills. In the same year there were around 24 million prescriptions in United States, these 24 million prescriptions became almost 3 billion pills containing PROPOXYPHENE. This is 3 followed by nine zeros…

    The medical product authorities in UK; the MHRA, decided January the 31st, 2005 that PROPOXYPHENE – products would be phased out in the country till the end of the year. They did not succeed doing that. Why, there were so many problems to stop using the drug for the users, so many side effects, so much suffering to get rid of the drug.

    MHRA then decided the drug to be out of the market in the end of the year 2006, but they did not succeed this time either. Today – the MHRA are saying that the drug definitive will be out of the market last December this year. Will they do that??? I do hope so.

    Why do not the US authorities inform the American society about these harming drugs? We can put the answer in just two worlds, THE LAW. We have different laws in Sweden and in US. In Sweden we have one federal law for all four branches of the forensic medicine, which are medicine, chemistry, psychiatric and genetics.

    In United States you have different laws in different states. In some states you have the old English system of CORONERS – and they are more investigators than medical doctors, you also have the MEDICAL EXAMINER SYSTEM, and they are medical doctors, but usually not specialists in forensic medicine.

    And most important of all, in Sweden, the medical doctors take a blood test of all dead persons that come to the forensic medicine station. And these blood tests are all screened for every legal drug there is in Sweden, and that includes PROPOXYPHENE. Thanks to that routine we find our PROPOXYPHENE-cases, and unfortunately you do not find so many PROPOXYPHENE cases.

    In Unites States, the decision to take a blood test is on the level of every one of the 3 200 counties in the country. And by many reasons the needed blood tests are mostly not taken. I think this is a big problem for your country, you loose lots of important information in many areas of medicine, missing the prevalence of PROPOXYPHE is just one.

    I would like say a few more worlds about who are responsible for these tragedies, the many fatalities due to poisoning from PROPOXYPHENE. The manufacturers are, as I said earlier – ELI LILLY. The have earned billions of dollar during the last 47 or 48 years. Why do I not say the last 50 years?

    The reason I say 47 or 48 years is that ELI LILLY sold the rights to their brands DARVON and the others – to some less known US pharmaceutical companies. And these companies were apparently not aware of our research. If they have known about this research, they would have been stupid to get into this crazy business of a drug that kills. LILLY has known about research since 1999 – at least in Sweden. We have printed proof for that.

    LILLY is afraid of the consequences when the drug will be banned. They are afraid of how many people that will sue them because they have lost some dear ones, a father, a mother, a brother, a sister, a cousin, an aunt, an uncle or just a very closefriend – that have died after that they have used a painkiller, fore example DARVON, DARVON-N or DARVOCET.

    Do you remember VIOXX?? This drug was withdrawn from the market in 2004. The manufacturer, MERCK & Co, said that there was in increasing risk to get heart problem when using VIOXX. They talked about increasing risk,we talk about fatal deaths,
    thousands of fatal deaths – just in United States. Now MERCK & CO has to pay billions of dollars in damages.

    You can say, that ELI LILLY, almost to the last minute – earned millions of dollars every year on their PROPOXYPHENE- drugs. Both in Sweden and in UK they did thesame thing. They sold DISTALGESIC to another company in Sweden and UK. Kind of a surprise for this company MEDA – they bought a drug that was banned just after a short time.

    Money are apparently more important than human lives for ELI LILLY, It is a simple as that.

    I would like to finish this message by telling you how things could develop. After restrictions were implemented twice in Sweden, 2001 and 2005, thanks to our research – we now can say that 500 – 600 lives have been saved, just in Sweden.

    During 1992-99 some 200 persons were poisoned to death every year. The Medical Product Agency in Sweden recently informed that during the year 2005, 56 persons were poisoned to death. And we feel proud of what we have done to save lifes.

    We now feel a moral obligation to inform about the dangers with PROPOXYPHENE all over the world. And we know that, when the FDA will ban DARVON and the OTHER PROPOXYPHENE-brands, lots of lives- thousands and thousands – will be saved in Unites States. If the FDA doesn´t do that, the sad story continues.

    We thank you for watching this video.

    Good bye

    Ulf Jonasson

    ……………………………………………………………………..
    Ulf Jonasson
    Doctor of Public Health(DrPH), Journalist
    Lövdalsvägen 5, S640 20 Björkvik, Sweden
    Phone: +46(0) 155-714 55
    Cellphone: +46(0) 730 23 26 00
    http://www.folkpartiet.se/ulfjonasson
    …………………………………………….

    Also visit:
    http://www.youtube.com/results?search_query=jonasson+darvon&search_type=
    Darvon, Distalgesic, Co-Proxamol – the worst drugs ever

    http://forum.skalman.nu/viewtopic.php?f=49&t=30287&st=0&sk=t&sd=a
    Tage Erlander möter president Truman den 14 april 1952


  3. on November 9, 2008 at 2:43 am Ajlouny

    It’s alarming how in one place it’s unacceptable to prescribe the drug but here in the US it’s OK to prescribe it. If it’s dangerous, it should be taken off the shelf and considered dangerous for everyone.



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