FDA Recall of Darvocet Leads to Ban in Canada

Darvocet and Darvon are brand-name prescription drugs that both contain the painkiller known as propoxyphene, sometimes called dextropropoxyphene. These medicines had been prescribed for decades in North America. In late November 2010 the FDA requested that the drugs’ manufacturer, Xanodyne Pharmaceuticals Inc, pull all medicines containing propoxyphene from the U.S. market due to serious side effects that can include fatal heart failure. Two weeks later, on December 1, 2010, Health Canada issued a mandate that required the medicines to be withdrawn from the Canadian market, citing the risk of severe heart problems that can come from taking propoxyphene.

Montreal-based Paladin Labs Inc. issued a statement that was backed by Health Canada. It reads, in part: “Results of a new study show that, even at doses normally taken to manage pain, dextropropoxyphene can significantly increase the risk of serious abnormal heart rhythms.”

Propoxyphene is a weak opioid and functions as a painkiller used in treating such ailments as restless leg syndrome and general muscle pain. The drug had been heavily criticized ever since its approval by the FDA in 1957. The FDA rejected the first appeal for propoxyphene’s recall, which came about in 1978 after the medicine was associated with a string of suicides in the United States. The U.K. mandated a recall of propoxyphene in 2005, referring to a risk of overdose. The European Union did the same years later, banning the medicine in 2009.

It wasn’t until 2010 that the FDA finally found just cause for banning propoxyphene in America. Upon reconsideration of a 2009 study, the agency determined that propoxyphene had a demonstrable tendency to cause “significant changes to the electrical activity of the heart.” The FDA then requested that Xanodyne, which is based out of Newport, KY, remove Darvocet (which contains both propoxyphene and acetaminophen) and Darvon (propoxyphene) from U.S. shelves. On November 19, 2010, the FDA stated that Xanodyne and all other U.S.-based companies that produced generic versions of the drug had observed the recall. Two weeks later, Paladin Labs Inc., the Canadian manufacturer of propoxyphene, issued a statement declaring their intention to withdraw the drug from the Canadian market.

As printed in the Wall Street Journal, in the year 2007 alone 10 million prescriptions for Darvon and Darvocet were given. It is not known exactly how many Canadians will feel the effects of the recent Darvocet ban. Public Citizen is a public interest group based in the United States, and the same group which first requested that the FDA recall propoxyphene in 1978. The group estimates that “at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene” since 2005, when the drug was banned in the United Kingdom. Public Citizen also stated its intention to back a congressional investigation in the U.S., where a class action Xanodyne lawsuit is already making its way through the court system.

After the Canadian recall of Darvocet in late 2010, legal experts anticipate a Canadian Darvocet lawsuit will soon follow.