Following the release of new clinical data linking the drug to heart rhythm abnormalities, the FDA has requested a recall of propoxyphene, a prescription pain medication. Xanodyne, the pharmaceutical company which manufactures propoxyphene under the brand name Darvon and Darvocet, has agreed to withdraw the medication.
Darvon and Darvocet Side Effects: Abnormal Heart Rhythms
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
According to available data, even small changes in a patient, such as dehydration, a change in medication, or changes in kidney function, can impact the risk of adverse propoxyphene side effects.
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.
Doctors and other healthcare professionals have been advised to stop prescribing Darvon, Darvocet, and generic propoxyphene-containing products. Patients taking any of these medications should speak with their doctors about possibly changing their pain management therapy to avoid experiencing the serious cardiac side effects of Darvocet and Darvon.