FDA Watch: FDA Sued Over Darvon, Darvocet

Darvon and Darvocet

The FDA has been sued over it’s failure to act on a petition to ban the painkiller Dextropropoxyphene (Darvon, Darvocet). The narcotic propoxyphene is both highly addictive and notoriously weak—studies have shown ibuprofen is often more effective.

“Propoxyphene (Darvon) Has Hazardous Side Effects And Is No More Effective Than Similar Drugs.”

-Public Citizen Website

A group called Public Citizen petitioned the FDA to ban the drug over two years ago, and even though propoxyphene-based painkillers have been banned in Britain since 2005, the FDA has thus far refused to make a move. In Great Britain propoxyphene has been tied to accidental deaths and suicide, and U.S. doctors have known about the drug’s propensity for chemical dependence for years. So, you ask, why hasn’t the FDA banned it here in the states?

Because in the U.S., propoxyphene—sold under the brand names Darvon and Darvocet—is one of the most widely prescribed painkillers on the market. Americans filled 22 million prescriptions for propoxyphene-based painkillers in 2007 alone. That’s quite a few tacos for drug companies like Mylan*. Can’t get any simpler than that…

*Mylan aquired Darvon and Darvocet from Eli Lilly, the drug’s original creator and manufacturer.


Read the full text of the Public Citizen v. FDA Complaint.

Public Citizen Press Release: Public Citizen Sues FDA for Failure to Act on Dangerous Drug -06/19/2008

KLEW TV: FDA sued for failure to act on risky painkiller

Image courtesy Wikipedia


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3 Responses to “FDA Watch: FDA Sued Over Darvon, Darvocet”

  1. Dr Ulf Jonasson Says:

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



    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.

  2. Darvon Consumer Says:

    I’ve been taking Darvon 65 for over 30 years, and it is the ONLY medication that gives me relief from my daily headaches. My doctor put me in the hospital for a week once, to try alternative medicines, and NOTHING worked for me but Darvon 65. The FDA MUST NOT ban Darvon, it would affect my quality of life tremendously.

  3. robert Says:

    we just our 31 yr. old child on darvocet

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