The FDA recall of Darvocet and Darvon which are the trade names for propoxyphene was long overdue. These drugs have been on the market for over 50 years. The FDA memorandum dated November 19, 2010 on the recall sets forth some science on Darvocet that should be helpful in understanding the dangers of this drug.
First, Darvocet is cardiotoxic when used as directed on the label. That means that when used as directed Darvocet causes chemical changes in the heart that affect its electrical system. These changes in the heart’s electrical system can cause heart arrythmias. In some cases these unnatural heart rhythms can cause ventricular fibrillation. This means that your heart stops pumping blood. This can and does frequently result in sudden cardiac death. This is probably the cause of most of the deaths from Darvocet aside from overdoses. A disruption of the heart’s electrical system from Darvocet could also cause atrial fibrillation which could trigger a stroke or heart attack from a blood clot. An electrocardiogram or EKG is the test that is used to detect heart rhythm malfunctions.
The FDA report points out that elderly people or people with reduced kidney or renal function are most likely at risk for propoxyphene-induced cardiotoxicity. Individuals with pre-existing arrthymias would also be at increased risk. That is because those individuals are less able to naturally clear the toxic substances from their bodies. However, the most recent study shows that even healthy individuals taking normal doese were at risk of heart failure and sudden death from Darvocet.
The good news for Darvocet patients is that the medical literature does not indicate that Darvocet has a latent effect after the drug is discontinued. The FDA also observed that there does not appear to be a cumulative effect on the heart after the person stops taking the drug. There has not been much study of this question because most of the scientific reports and literature on Darvocet and Darvon have focused on treatment of overdose in emergency rooms. Since Darvocet and Darvon are opiates and are addictive many deaths may have been attributed to opiate overdoses causing respiratory failure and may not have been closely investigated.
I expect that most of the individual lawsuits and class action lawsuits that are being filed will involve sudden cardiac death cases. A cardiac arrythymia caused by Darvocet or Darvon should be treatable most of the time without permanent damage in most cases. However, it is possible that heart malfunction for a temporary period could cause health damage of other types. For example, lack of blood to the brain or other organs during the period of heart dysfunction could cause significant permanent problems. This would be the basis of a negligence or product liability lawsuit against the manufacturer of the drug.
I would be happy to discuss the science or legal issues with anyone that would like to comment or email or telephone me.
Admitted to practice law in all federal multidistrict litigation courts, the California State Bar and the Florida Bar. His philosophy is to provide aggressive, quality representations and seek fair compensation for individuals and their families who have suffered injury, death, or sexual abuse.