The FDA has pulled Darvon and the related brand Darvocet from the marketplace. In addition, the FDA ordered generic drug makers to discontinue making drugs containing propoxyphene - the active ingredient in Darvon. Britain outlawed Darvon in 2005 and the European Union outlawed Darvon in 2009. The FDA pulled the drug based on new research showing that it leads to heart arrhythmias. Other side effects such as increased suicidal rates and accidental overdoses were instrumental in the European Union’s banning of the drug. Propoxyphene is also noted for its high death rate associated with intake. The death rate for patients taking propoxyphene is 16 deaths per 100,000 prescriptions.
The initial requests to remove propoxyphene were submitted to the FDA in 1978. The FDA took no action at that time citing that the benefits of the drug outweighed its risks. In January 2009, the FDA voted 14 to 12 in committee to discontinue propoxyphene products in the marketplace. In July 2009, the FDA changed its decision and allowed propoxyphene to continue in the marketplace but with increased warning label requirements.
The FDA notes that recent research shows that even when taking normal dosages of propoxyphene the drug causes “significant changes to electrical activity of the heart.” These changes show up in ECG (electrocardiogram) tests and propoxyphene is linked to a high risk rate for “serious abnormal heart rhythms.”
