Propoxyphene is a d medicine that has been marketed in approved drugs such as Darvon and Darvocet since 1957. Darvon is a narcotic analgesic, used to relieve mild to moderate pain. It has shown many severe side effects in the patients taking this medicine. It has been banned in many countries earlier. Later FDA banned this drug. The FDA action came nearly six years after the drug was already banned in the U.K., and around eighteen months after the European drug agency banned it. In 1978 and again in 2006, the public interest group Public Citizen petitioned the FDA to ban the drug. The petition of 2006 forced the FDA to put the matter in front of an expert advisory committee. This committee voted 14-12 to ban the drug in July 2009.

On July 7, 2009, the Food and Drug Administration (FDA) announced actions against Propoxyphene medicine such as Darvon and Darvocet. Overdose of these medicines has resulted in death in many patients. The patients of propoxyphene have most often reported side effects such as light headedness, dizziness, sedation, nausea, and vomiting. FDA found that in recommended doses, this drug is effective but can cause severe harm with overdose. Because of the drug’s potential risks, the agency asked the manufacturers to provide more information to help physicians and patients so that they can judge better whether propoxyphene is the appropriate pain treatment.

FDA Actions

FDA has tried to control the damage caused by propoxyphene medicines such as Darvon by taking following actions-

  • FDA asked manufacturers of propoxyphene-containing products to give strong warning and highlight the label’s boxed warning so that the risk for overdose when using these products can be clearly highlighted.
  • FDA asked the manufacturers to provide a medication guide (FDA approved information for the medicine which must be provided to patients with each prescription or refill of the medicine) to stress the importance of using the pain drugs only as directed.
  • FDA also asked for a new safety study to find out more about the effects of propoxyphene on the heart at higher than recommended doses.
  • FDA decided to take help of other federal agencies, such as the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs, so that it can conduct fresh studies on the safety of products containing propoxyphene in comparison to other commonly used pain medications.
  • FDA decided to further evaluate the safety of propoxyphene and take additional regulatory action, if necessary.
  • FDA has denied the citizen petition from the public interest group Public Citizen. This petition was filed to ensure a phased withdrawal of propoxyphene.

Though expert advisory committee, which voted 14-12 to ban the drug in July 2009, FDA did not banned the drug but tried to control its harm by regulating the safety norms for this drug. FDA found it to be useful when used in a doctor’s guidance in prescribed dosages. .

Many lawsuits had been filed against the Darvon after it caused severe harm to many patients. It was said to cause heart related problems in the patients and many other side effects were also evident. All these forced FDA has forced FDA to take this action.

What should consumers do?

This action has left patients in confusion that what to do.

  • While opting for a pain killer be cautious of the side effects and risks associated with the medication, including propoxyphene. Remember most of the pain killers have side effects varying from mild to severe.
  • Consult your doctor before taking any pain treatment.
  • Its advisable not to stop Darvon all of a sudden as it can cause withdrawal symptoms. So consult a doctor before stopping it.

Present Status

Numerous lawsuits and complains of severe harms forced FDA to take harder action against this drug. In the month of November 2010, FDA confirmed the request to withdraw all products containing propoxyphene from the markets. It was forced to do so after a new study showed that the drug could cause heart rhythm abnormalities in healthy patients even at recommended doses.