Why Was A Darvocet Recall The Best Option For Patient Safety?

by Terry Bryant

Though dextropropxyphene and the medications that contain it have been around for decades, the FDA instituted a Darvocet recall in November, 2012. Until 2009, the agency had considered the medication to be safe for general use, but after reviewing compiled statistics provided by medical examiners around the country, this opinion changed. Now, this drug has been removed from the U.S. market, mostly due to its propensity to cause heart failure via arrhythmia.

This prescription drug is an opioid-based pain and cough reliever that has some anesthetic effects as well. However, even at normal doses, it is a highly effective sodium channel blocker. This affects the heart’s potential for electrical conduction which can result in the heart failing to beat correctly, sometimes fatally. The medical examiner data provided to the FDA affirm the severity of these risks.

Between 2003 and 2007, medical examiners in Florida tracked the number of deaths caused by three popular pain relievers: tramadol, hydrocodone and dextropropxyphene. Darvocet was found to be the primary cause of death about twice as often as tramadol or hydrocodone when present in the deceased patient’s system.

The Drug Abuse Warning Network (DAWN), produced results that were even more striking. They tracked the same data produced by eight states in the U.S. between 2004 and 2007. The results found that per 100,000 prescriptions, dextropropxyphene was more likely to cause death in seven of the eight states than either tramadol or hydrocodone. This was especially true in Vermont, where the death rate was four times that of hydrocodone and about five times higher than that of tramadol.

With these facts before them, the FDA concluded that a Darvocet recall was the best option for patient safety.