On November 19, 2010, Xanodyne Pharmaceuticals relented to the FDA’s request to begin a Darvocet recall. Even though the product had been approved by the FDA and sold for decades, aggregate statistics gathered over many years by medical examiners found some troubling concerns. The FDA appointed a special advisory committee to review this data in 2009. Based on its recommendations, the agency concluded that better labeling was needed to ensure proper dosing. However, just months later, it was discovered that even proper dosing of the medication can result in serious changes to the body that may result in severe, even fatal, complications. As a result, the FDA’s Darvocet recall has required all dextropropxyphene-based products to be removed from the U.S. marketplace.

This drug is an opioid analgesic designed to provide relief from mild pain. It is also valued for its anesthetic and antitussive (cough suppressing) qualities. Some clinics also use it to help people addicted to opioids because its effect is mild compared to other opioids.

The primary reason the FDA demanded a Darvocet recall is the medication’s tendency to cause heart arrhythmias in patients, even at normal doses. Dextropropxyphene produces a range of side effects, and is a powerful local anesthetic in higher doses. If not prescribed correctly, a patient may suffer from profound confusion while using it. This is why many patients on dextropropxyphene, especially when mixed with other prescription medications, have accidentally overdosed.

Even in normal dosing, cardiac arrhythmias can present that are capable of causing acute heart failure
. The medication is a potent sodium channel blocker that can alter the electrical conductivity of the heart causing irregular heartbeats. Most of the deaths associated with this drug have been found to result from these arrhythmias. Data from medical examiners confirm this. Medical examiners in Florida tracked the number of deaths caused by this medication, tramadol and hydrocodone between 2003 and 2007. They found that the use of dextropropxyphene resulted in about 4 fatalities per 100,000 prescriptions. This was nearly twice the number of tramadol and hydrocodone.

The Drug Abuse Warning Network, or DAWN, tracked deaths caused by these same drugs in eight states between 2004 and 2007, and found similar trends. Seven of the eight states reported dramatically higher fatalities per 100,000 prescriptions for dextropropxyphene, compared to tramadol and hydrocodone. This trend was most startling in Vermont, where the death rate of the recalled drug was nearly four times higher than that of hydrocodone and tramadol.

For these reasons, the FDA believed the only course of action was to pursue a Darvocet recall. Even though it had been available for decades, this medication is now considered a safety threat to U.S. patients.