Darvon, Darvocet Withdrawal Late in Coming

The decision to finally pull Darvon and Darvocet from the market has spawned criticism of the US Food & Drug Administration (FDA) by those who say it waited too long to act on the dangerous painkillers. Darvon and Darvocet have been on the market for more than 50 years, and for much of that time have been the subject of safety concerns.

Darvon and Darvocet are both made with propoxyphene, an opiod painkiller. It was already known that propoxyphene could be highly addictive. It’s now been shown that Darvon, Darvocet and other propoxyphene products can cause dangerous, and even fatal, heart rhythm problems. Darvon and <"http://www.yourlawyer.com/topics/overview/darvocet">Darvocet side effects may include the following cardiac disorders:

• Fatal Abnormal Heart Rhythms
• Arrhythmia
• Bradycardia
• Cardiac/Respiratory Arrest
• Congestive Arrest
• Congestive Heart Failure (CHF)
• Tachycardia
• Myocardial Infarction (MI)

In 1978, the consumer group Public Citizen first petitioned US regulators to remove the drug from the market. In 2006, the same group filed yet another petition on Darvon recall to the FDA, asserting that the drugs had been associated with the deaths of at least 2,110 people between 1981 and 1999. Dr. Sidney Wolfe, the group’s director, also asserted that propoxyphene was a relatively weak painkiller and posed an unacceptable toxic risk to the millions of patients prescribed it each year. The FDA failed to act.

Others saw the danger the FDA chose to ignore. The United Kingdom banned propoxyphene in 2005 and the entire European Union followed suit in January of 2009.

In January 2009, an FDA advisory panel narrowly voted 14-12 to recommend that the FDA remove Darvon and similar products from the market. Rather than heed the advice of its advisory panel, the FDA decided to permit continued marketing of Darvocet and other propoxyphene products, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. While the new warning did not include mention of heart rhythm problems, the agency required Xanodyne Pharmaceuticals, the company that markets Darvon and Darvocet, to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

Ultimately, that study found that even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. That study finally prompted the FDA to ask Xanodyne Pharmaceuticals to remove Darvon and Darvocet from the market, and last week, it was announced that the company had agreed to do so. The FDA said it would also ask the makers of generic propoxyphene products to do the same.

On Friday, Public Citizen blasted the FDA for taking so long to protect the public from drugs like Darvon and Darvocet.

“Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since time the UK ban was announced,” the group said in a statement. “The best forensic data, the kind relied upon in those countries for the UK and European bans, come from Florida where, because of routine drug testing required by the state medical examiner as part of many autopsies, deaths are categorized as being ’caused’ by certain drugs if the levels found are to be above a certain level. From 2005 through 2009, in Florida alone, 395 deaths were “caused” by propoxyphene. If data from 2007 are representative, in that year, 78 percent of the Florida deaths caused by propoxyphene were ruled accidental.”

Public Citizen said it will call for a congressional investigation “into who in the FDA, specifically in the Center for Drug Evaluation and Research, was responsible for the loss of so many lives in this country. It is clear that long before today, many drug safety experts in the Office of Surveillance and Epidemiology had decided the drug should be removed from the market.”

For help with legal claims involving Darvon and Darvocet, please visit <"http://www.yourlawyer.com/topics/overview/darvon">www.yourlawyer.com.

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