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Darvon pulled from US market

Xanodyne Pharmaceuticals has agreed to a US FDA request to withdraw its opioid pain medications Darvon and Darvocet due to a link to serious cardiac side effects

Xanodyne Pharmaceuticals has agreed to a request from the US Food and Drug Administration (FDA) that the company withdraw its opioid pain medications Darvon (propoxyphene) and Darvocet (propoxyphene and acetaminophen) from the market due to a link to serious cardiac side effects.

Generic versions of the drugs will also be pulled from the US market.  

The FDA said it based its request on new clinical data showing that propoxyphene, which was originally developed by Lilly, puts patients at risk of potentially serious or fatal heart rhythm abnormalities. The data came from a study that the FDA required Xanodyne to conduct after an advisory committee voiced concerns about the pain drugs. The clinical data were also corroborated by new epidemiological data, the agency noted. 

"These new heart data significantly alter propoxyphene's risk-benefit profile," said John Jenkins, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."

Healthcare professionals have been advised to stop prescribing the drugs, and patients who take the drugs have been advised to see their healthcare professionals to discuss switching to another therapy. 

Darvon has been marketed in the US for the treatment of mild to moderate pain for more than 50 years. In 1978, the FDA received a request from the consumer advocacy group Public Citizen to pull the drug from the market. In 2006, the group issued a citizens' petition urging a ban. However, the FDA maintained that the drug's benefits outweighed the risks. In 2008, the consumer group sued the agency for a response to the petition, leading the agency to convene an advisory committee to make a recommendation on the drug. 

Early last year, the advisory committee voted 14 to 12 to recommend that the agency require that Darvon, Darvocet, and the generics be removed from the market. The advisors cast their votes after reviewing the data submitted with the original drug applications, as well as subsequent medical literature and postmarketing safety databases.  

In response to the advisory committee's vote, the FDA decided to allow continued marketing of the drugs, but added a boxed warning about the risk of fatal overdose to the products' labelling and required Xanodyne to conduct the cardiac safety study. 

The study data show that, even when taken at recommended doses, propoxyphene can increase the risk of serious abnormal heart rhythms that can lead to sudden death. However, the FDA stressed that the effects are not cumulative and that patients who have been taking the drug for many years will see their risk reversed once they stop usage.

Responding to the news that the drugs would be removed from the market, Public Citizen issued a statement sharply criticising the FDA for taking until now to make the decision, calling the years that Darvon and Darvocet remained on the market after safety concerns began to be raised "a deadly delay".

"We will ask for and support a Congressional investigation into whom in the FDA, specifically in the Center for Drug Evaluation and Research, was responsible for the loss of so many lives in this country," Public Citizen said. 

The European Medicines Agency (EMA) recommended last year that the marketing authorisations for propoxyphene be withdrawn across the EU, and a phased withdrawal is currently ongoing. 

22nd November 2010


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