Thin Safety Margin, Ineffectiveness, and Abuse Potential Should Have Prompted Earlier Darvon Darvocet Recall

Thin Safety Margin, Ineffectiveness, and Abuse Potential Should Have Prompted Earlier Darvon Darvocet Recall

The Food and Drug Administration (FDA), in issuing a market withdrawal of products containing the synthetic opiate propoxyphene, cited a new study that links the drug to changes in a user's heart rhythm that could potentially result in a fatal heart attack or stroke. Although evidence had previously suggested that propoxyphene was a dangerous cardiotoxic agent, the new research confirms this suspicion. In particular, the finding that the drug can cause cardiac complications even at therapeutic does in healthy patients prompted the FDA's Darvon/Darvocet recall.

One of the particularly dangerous aspects of propoxyphene is the drug's thin safety margin. That is, even at doses slightly above what is recommended, it can be toxic. At just four times the standard dose, propoxyphene can cause dangerous drops in heart rate and breathing. Increasing the dosage to six times the recommended amount can lead to toxic psychosis and seizures. Such a narrow divide between safety and toxicity is worrisome in and of itself. But due to the ineffectiveness of propoxyphene as a painkiller and its addiction potential, such health risks are exacerbated.

There is wide consensus among medical professionals that propoxyphene has weak analgesic properties. As far back as 1970 researchers have found that medications such as Darvon relieve pain no more effectively than two aspirin. In fact, the authors of one study concluded that propoxyphene may even be inferior to aspirin. Because it does not provide the pain relief that many individuals, such as post-operative patients, require they may take more pills and exceed their prescribed dosage. As mentioned above, even slight increases in propoxyphene intake can cause toxicity, which could lead to a heart attack, stroke, or other cardiac complications.

Taking more propoxyphene than the prescribed daily amount also has the potential to create dependency, another scenario that greatly increases the drug's ability to cause catastrophic side effects. Like other narcotics, propoxyphene has the potential to create physical addiction, psychological dependence. And because the drug additionally promotes tolerance, users must continue to take larger doses to achieve the same effect. As doses increase, so too does the likelihood of ingesting a toxic, and potentially lethal, amount of propoxyphene.

Propoxyphene's weakness as a pain reliever and potential for abuse result in many accidental overdose deaths, especially when a "cocktail" of propoxyphene and depressants (such as alcohol) is consumed. According to data gathered by the Drug Abuse Warning Network (DAWN) more than 40 percent of propoxyphene-related deaths are accidental (as opposed to 30-40 percent that are attributed to suicidal overdose). Furthermore, consistent with the study that led to the FDA's recall, more than three-quarters of propoxyphene overdose deaths are the result of cardiac toxicity.

The FDA likely made the right choice when it banned propoxyphene from the U.S. market. Although some consumer advocates have argued that the agency delayed action at the cost of thousands of lives, its decision to issue a Darvocet recall will surely spare many thousands more the same fate. The recall, however, may not have come soon enough to prevent you from suffering a heart attack, stroke, or developing an arrhythmia, atrial fibrillation, an irregular heartbeat, or other cardiac complications. If you experienced any of these well-documented propoxyphene side effects, you may be entitled to compensation from the drug's manufacturer. Patients nationwide are taking legal action in response to the recall. Contact the Rottenstein Law Group today to discuss a potential Darvon recall lawsuit.

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