I recently found out that Darvocet had been banned in the US. Being allergic to pain killers in the Vicodin family this severely limited my doctors choices in prescribing pain killers for me.

So I did some research into why...

Nov. 19, 2010 -- The FDA has at last banned Darvon, Darvocet, and other brand/generic drugs containing propoxyphene -- a safety-plagued painkiller from the 1950s. ... The FDA action comes nearly six years after the drug was banned in the U.K., and nearly a year and a half after the European drug agency banned it.

"Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since the time the U.K. ban was announced," Sidney Wolfe, director of Public Citizen's health research group, says in a news release.

I am skeptical that a drug that had been around that long would actually be responsible for 200-400 deaths a year with out a large outcry. Is there any data to back this up?

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    killing 200-400 people a year really isn't that many people for a drug like that, which had millions of prescriptions filled per year and likely hundreds of thousands or more taking it. – Ryathal Oct 3 '12 at 20:37
  • @Ryanthal - Evidently it was bad enough to get one of the most popular prescription painkillers removed from the market entirely. – Chad Oct 3 '12 at 21:16
  • @Chad FDA press annoucnement: fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234350.htm is has been banned in several countries I don't know what else you are looking for, also where is the notable claim stating that is not dangerous? – isJustMe Oct 3 '12 at 22:03
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    @rvs there doesn't need to be a claim that its not dangerous, its a perfectly valid question to link to someone saying its dangerous and ask is what they are saying accurate – Ryathal Oct 4 '12 at 12:11
  • @rvs - I am not saying it is not dangerous. I am skeptical of the unsourced claim that 1000-2000 people died from it in the US in the 5 years between when UK banned it and when the US Banned it. Especially when you consider that there were only 27 deaths associated with the Ford Pinto defect but the outcry was huge. – Chad Oct 4 '12 at 12:58

There is significant evidence that Propoxyphene is more dangerous than its alternatives. The study "Co-proxamol overdose is associated with a 10-fold excess mortality compared with other paracetamol combination analgesic" published in 2005 in the British Journal of Clinical Pharmacology states:

When related to prescription volume overdoses involving co-proxamol in Scotland were 10 times more likely to be fatal (24.6 (19.7, 30.4)) when compared with cocodamol (2.0 (0.88, 4.0)) or co-dydramol (2.4 (0.5, 7.2)).


The excess hazard from co-proxamol is due to inherent toxicity rather than increased use in overdose. We estimate from this study that withdrawal of co-proxamol would prevent 39 excess deaths per annum in Scotland alone.

There is also strong evidence that the withdrawal in the UK lead to a reduced number of deaths. The article "Effect of withdrawal of co-proxamol on prescribing and deaths from drug poisoning in England and Wales: time series analysis" published in 2009 in BMJ states as a result:

These changes were associated with a major reduction in deaths involving co-proxamol compared with the expected number of deaths (an estimated 295 fewer suicides and 349 fewer deaths including accidental poisonings), but no statistical evidence for an increase in deaths involving either other analgesics or other drugs.

This translates into more than a hundred deaths due to Propoxyphene per year in the UK, which is similar to the number you quoted if you take the different population sizes into account. The United States have roughly 5 times the population of the UK, which would translate into roughly 2500 deaths over 5 years.

There is also evidence that Propoxyphene is not more effective than alternatives:

On the basis of data on analgesic efficacy and acute safety in both head to head and indirect comparisons, there is little objective evidence to support prescribing a combination of paracetamol and dextropropoxyphene in preference to paracetamol alone in moderate pain such as that after surgery.

If you have a drug with a questionable safety record that seems to be of limited effectiveness, it makes a strong argument to reconsider the use of this drug entirely.

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    @Chad And I quoted some data from the UK that makes the US estimate a plausible one. – Mad Scientist Oct 4 '12 at 13:14
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    @Chad That sentence supports the claim that propoxyphene is more dangerous than the alternatives. It means that by banning the drug the deaths were actually reduced, and not just shifted to alternative drugs. – Mad Scientist Oct 4 '12 at 13:26
  • @Chad Then you should rephrase the title of your question, this answer perfectly answers what you ask on the title, if you want to dig in about the deaths then change the title. – isJustMe Oct 4 '12 at 15:11
  • @Fabian - OK I read that wrong. Ill give you a +1 for showing plausibility. – Chad Oct 4 '12 at 15:18
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    Of course while the drug increases risk for the general population, a few hundred deaths out of millions of users isn't that high an absolute risk. In the case of someone who is allergic to the otherwise safer alternatives, it would make sense to allow you to take the more dangerous drug if you were prepared to take that extra risk. – Nick Oct 4 '12 at 17:10

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