FDA ORDERS PROPOXYPHENE, Dextropropoxyphene, Darvocet and others off Drug Store Shelves

SOURCE - Consumer Acumen

The FDA has asked that Dextropropoxyphene aka Propoxyphene - Trade-names for Propoxyphene include Darvocet-N and Di-Gesic Darvon with APAP for dextropropoxyphene and paracetamol and Darvon with ASA for dextropropoxyphene and asperin. According to the FDA Report, Propoxyphene "puts patients at risk of potentially serious or even fatal heart rhythms” and concluded its risks outweigh the benefits of using Propoxyphene for pain relief. Darvon is propoxyphene alone, and Darvocet combines that ingredient with acetaminophen (aka Tylenol)

Other brand names of Propoxyphene included in the recall are Darvon and Darvocet, Xanodyne Pharmaceuticals be removed from the US market. The Propoxyphene recall will also effect generic Propoxyphne manufacturers and the manufactorers of propoxyphene-containing products. The maker of the branded version of the drugs, Xanodyne, has already said it will comply with the Propoxyphene recall notice.

The FDA has told medical professionals to stop prescribing propoxyphene. Patients who are taking the stated medications should not sinply stop taking it, ut should contact their doctor soon as possible to discuss switching to another pain-management therapy. The WSJ reports that in 2007, there were 20 million prescriptions written for the two drugs.


Propoxyphene is an opioid typically used to treat mild to moderate pain. It was first approved by the FDA in 1957. It is sold by prescription under various names alone or in combination with acetaminophen. Since 1978, the FDA has received two requests to remove propoxyphene from the market.


Darvon has been controversial for years. Public Citizen started asking for its removal way back in 1978 and today said the FDA’s move came too late to save many lives. It called propoxyphene a “deadly but barely effective painkiller.” (Though the Health Blog has been prescribed Darvocet before and it certainly left us feeling no pain.)

In 2005, the UK ordered propoxyphene off the market on concerns that it was too easy to overdose on the drug. Europe’s main medical regulator recommended its removal in 2009.

About a month after the European decision, the FDA said it would require a boxed warning on Darvon and Darvocet. It ignored the advice of an outside advisory panel to pull the drugs entirely, saying they were an “acceptable” option when used at recommended doses. It said it required Xanodyne to conduct a new safety study and that those results are what led to today’s action.

In January 2009, an FDA advisory committee voted 14 to 12 against the continued marketing of propoxyphene products. At that time, the committee called for additional information about the drug's cardiac effects.


For those patients being removed from Propoxyphene, you should be aware of the possible side effects of Opioid Withdrawl. In pure form, dextropropoxyphene is commonly used to ease the withdrawal symptoms in people addicted to opioids. Being very weak in comparison to the opioids that are commonly abused, dextropropoxyphene can only act as a "partial" substitute. It does not have much effect on mental cravings; however it can be effective in alleviating physical withdrawal effects, such as muscle cramps.

Some previously reported side effects of Propoxyphene include Urinary Hesitancy, Itching, Drowsiness, Sore Throat, Impaired Alertness, Confusion, and Serious or Fatal Heart Rhythms.