Last week, the manufacturer of Darvon and Darvocet, Xanodyne Pharmaceuticals, agreed to withdraw these drugs from the market in response to FDA requests. The FDA has also requested that generic drug manufacturers also stop marketing propoxyphene-based pain killers like Darvon and Darvocet. These drugs were withdrawn from the U.K. market almost six years ago. About a year and a half ago, the European drug agency also placed a ban on propoxyphene-based pain killers. An estimated 10 million Americans are taking propoxyphene-based drugs.
Although propoxyphene was always associated with a number of complications, the FDA’s request was prompted by new studies revealing the drug’s serious cardiovascular side-effects. The FDA was petitioned on a number of occasions to pull propoxyphene off the market. The latest petition came from the public interest group Public Citizen in 2006. The FDA submitted the petition to an expert advisory committee that voted in favor of withdrawing the medication in 2009 (14 to 12 ).
The FDA did not request that the medication be removed from the U.S. market in 2009. Instead, it requested that the manufacturer of the drug, Xanodyne Pharmaceuticals, Inc., conduct research to study the effects of the drug on the heart. This new research revealed that people taking propoxyphene (Darvon, Darvocet and the like) can develop abnormal or fatal heart rhythm. These findings prompted the FDA to request the withdrawal of the medication. Propoxyphene is also associated with the following cardiovascular complications:
- Cardiac/respiratory arrest
- Congestive heart failure
- Myocardial infarction
Some other side effects include:
- Drug overdose/toxicity
- Drug dependence/withdrawal
- Drowsiness/ dizziness
- Difficulty breathing
- Chest tightness
- Swelling of the face, mouth, lips or tongue
The Public Citizen group has claimed that about 2000 people in the U.S. have died as a result of propoxyphene in the last six years. The good news for those taking Darvon, Darvocet or a similar drug is that the cardiovascular side effects of these drugs are not cumulative. Therefore, the risk of developing cardiovascular problems should go away once the drug is stopped.
If you are taking Darvon or Darvocet, DO NOT stop taking the drug until you talk to your doctor. Sudden interruption of the medication can lead to serious withdrawal symptoms. If you are taking propoxyphene-based medications, contact your doctor immediately so that you may be transitioned to a safer pain killer.