Severe Heart Troubles Trigger Darvocet Recall

Darvocet and Darvon, both manufactured by Xanodyne Pharmaceuticals, Inc., were, until recently, two of the most commonly prescribed drugs in the United States. In late November 2010, the FDA mandated a recall for these drugs, saying that the serious risk of developing Darvocet heart problems as a consequence outweighed any benefits.
Both medications contain propoxyphene, which has been used as a treatment for mild or moderate pain following surgery. Now Xanodyne, as well as all generic makers of the drugs, have been forced to withdraw those medicines from the market.

U.K. Recalled Same Drugs more than Six Years Ago

Darvocet, Darvon, and all other drugs containing propoxyphene were banned in the U.K. in 2004. Yet they continued to be prescribed and consumed in the United States until late last year. Darvocet is quite similar to Darvon; it differs in that includes acetaminophen, the active ingredient in Tylenol.
In February 2009, an advisory panel to the FDA recommended an immediate Darvon and Darvocet recall. The panel found that both drugs carried a substantial risk of suicide or overdose that far outbalanced any pain relief they brought about. The FDA, however, declined to recall the medications, and instead applied a “black box warning” to the drugs’ labels. These black box warnings, which advise caution and describe the dangerous side effects, are the most forceful measures the FDA can take, short of a recall.

Previous Requests to Discontinue Darvocet

Since 1978, the FDA has received two different petitions seeking the recall of Darvocet and Darvon. In late 2010, Public Citizen, a consumer rights organization, filed a lawsuit against the FDA because they believe the agency broke the law when it neglected to act on a 2006 petition. The petition in question asked that Darvocet, Darvon, and all generic forms that contain propoxyphene be removed from the market due to a tendency to become physically addictive. More than 2,000 accidental Darvocet deaths have been attributed to these medications, and it has been determined that they do not offer substantially greater pain relief than other, safer prescription painkillers.