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: A Georgia Lawyer

December 7, 2010 Darvocet Legal Recall News and Updates

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Some folks are asking why did it take 30 years to pull Darvocet/Darvon off the market? As Dr. Sidney Wolfe, a drug expert at Public Citizen in Washington, D.C.,has said to many reporters: "Propoxyphene has been one of the top 50-selling drugs for at least 40 years," and its sales have generated huge profits for drug companies. Yet its dangers have been well known for most of that time.

Estimates are that several thousand people died as a result of taking the drug, countless others developed serious medical problems, and millions wasted money on an expensive painkiller that didn't work.
Over the years, many experts called for the removal of propoxyphene, but those calls were routinely ignored. Public Citizen petitioned the FDA to ban the drug in 1978 and again in 2006; finally, the group sued the FDA in 2008.

Six years ago, the drug was banned in the United Kingdom based on data that it didn't work and, at doses only slightly above those often prescribed, leads to accidental overdoses.

In 2004, British health authorities ordered a phased withdrawal of the drug, known in the U.K. as co-proxamol. It was withdrawn gradually rather than immediately because the narcotic has addictive properties and patients require adequate time to switch to other painkillers.

From the BBC in 2004: A popular painkiller is being withdrawn from the UK market over concerns about links with suicide. Co-proxamol, used by thousands for conditions such as back pain, will be phased out over the next year or two. Data showed fatal overdoses due to co-proxamol are the second most frequent means of suicide with prescribed drugs in England and Wales, accounting for up to 400 deaths each year.The risk of death associated with co-proxamol overdose seems to be higher than for either tricyclic antidepressants or paracetamol. http://news.bbc.co.uk/2/hi/health/4221829.stm

According to British health authorities, the drug was banned because ?each year there are 300- 400 fatalities following deliberate or accidental drug overdose involving propoxyphene/acetaminophen in England and Wales alone. Approximately one-fifth [60-80] of these deaths are considered to be accidental.? The British government further stated that the drug?s effectiveness ?is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.... It has not been possible to identify any patient group in whom the risk-benefit [ratio] may be positive.? http://healthfully.org/dnd/id8.html

Finally in 2008 the UK banned it outright. Interestingly, the UK's role seemed to be to reduce suicides, as opposed to concerns about heart conditions.

Read more here: http://blogs.wsj.com/health/2010/11/24/without-darvon-and-darvocet-whats-a-pain-sufferer-to-do/

Full post as published by A Georgia Lawyer on December 07, 2010 (boomark / email).