Darvocet recalled by FDA

The Darvocet recall lawsuit claims Xanodyne Pharmaceuticals failed to provide its patients with sufficient information related to the drug’s side effects as well as serious heart problems associated with its usage. Some of the most common side effects that have been reported with Darvocet include drowsiness, dizziness, and vomiting, though Darvocet has now been reported to be fatal in people with a history of heart disease. Darvocet was one of the most popular and commonly prescribed mild painkillers for several decades. Yet despite its popularity, consumer protection groups consistently called for its removal due to severe side effects, including Darvocet arrhythmia and even Darvocet death.
Darvocet, Darvon, and generic propoxyphene were taken off the market in November 2010.  While they are no longer available for prescription or for purchase, the drugs are still within public reach.  As long as forgotten bottles litter the shelves of medicine cabinets and illegal transactions are made, the threat of Darvocet is by no means over.
The results of a propoxyphene study, which prompted the Darvocet and Darvon recall, indicated that the drug significantly changes the electrical activity of the heart. These changes can be seen on ECGs (electrocardiograms) and may increase the risk of abnormal heart rhythms, which have been linked to serious adverse events, including death.
Other cardiac side effects of Darvon and Darvocet include:

• Slowed heartbeat
• Decreased ability of the heart to contract properly
• Interruption of the heart’s transmission of electrical impulses

Since 1978, the FDA has received two requests to withdraw propoxyphene from the market; however, it did not request a Darvon and Darvocet recall until November 2010.  In July 2009, the FDA placed a boxed warning on the drug, alerting patients and doctors of an overdose risk, and required that new safety studies be conducted to determine the side effects of propoxyphene on the heart. The results of this study revealed that even when taken in appropriate dosages, propoxyphene can cause significant changes to the electrical activity of the heart. After reviewing this information, the FDA decided that the drug’s effectiveness in treating pain no longer outweighed its risks.