Severe Side Effects of Darvon & Darvocet
On November 19, 2010, the U.S. Food and Drug Administration (FDA) announced that it had asked manufacturers of medications containing the active ingredient propoxyphene (chief among them Xanodyne, maker of Darvon and Darvocet) to remove those products from shelves nationwide. The conclusion of a recent study is that the drug might be toxic to the heart. Even when taken at recommended doses, propoxyphene can affect the heart’s electrical activity, and in rare cases, sudden death can occur. But even relatively small changes in one’s condition, such as dehydration, can result in an increased risk of an adverse reaction to the drug. Elderly patients and those with impaired kidney function are particularly susceptible, due to a decreased ability to eliminate propoxyphene from the body. Read more.
What Are Darvon and Darvocet?
Fifty years ago, those suffering from pain had very few options for relief. Aspirin was relatively weak; narcotics (such as codeine and morphine) were potent but addictive (and an allergen to some). When Eli Lilly and Co. developed the painkiller propoxyphene (marketed under the brand name Darvon), approved by the FDA in 1957, the drug seemed to be the happy medium that pain sufferers had prayed for. A mild synthetic opiate, propoxyphene effectively reduces moderate pain and is less addictive (and therefore less likely to be abused) than other narcotics. For twenty years propoxyphene was one of the most commonly-prescribed medications in the United States. Almost two decades after its introduction, from 1973 to 1975, an average of 39 million prescriptions for Darvon were written each year. Read more.
The Long Road to Withdrawal
The recent action by the FDA marks the end of a decades-long debate about the safety and effectiveness of propoxyphene. The debate began in November 1978—32 yeas ago—when the consumer advocacy organization Public Citizen first petitioned the FDA to ban the drug. The FDA declined. Public Citizen tried again in 2006, only to have the FDA rebuff its efforts once more. Public Citizen’s most recent petition, however, succeeded: In June 2008, it sued the FDA to force it to require the withdrawal of propoxyphene drugs from the U.S. market. The lawsuit prompted the FDA to convene a meeting of an expert advisory committee; the committee voted to ban the drug. The FDA overruled the panel’s decision, but the vote prompted further studies on the safety of propoxyphene. The results of these studies are what ultimately led to the FDA’s request for market withdrawal. Read more.
The Research That Led to Withdrawal of Darvon and Darvocet
To determine the safety of a drug, the FDA weighs the drug’s benefits against its risks. In other words, to the FDA safety is relative. According to the agency, the decision to request the withdrawal of Darvon and Darvocet from the U.S. market was based on new data that “significantly alter[ed] propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.” The FDA concluded that the risks of the drug outweigh its benefits for pain relief even at recommended doses. Read more.
FDA Withdrawal of Darvon & Darvocet
The FDA does not have the authority to issue a recall. It may request that a company recall a product—and companies typically will comply. But a request is just that. A company can deny the request, in which event the FDA’s only recourse (aside from applying pressure through the media) would be to seek a court order authorizing the federal government to seize the product in question. Generally, though, recalls are voluntary. Most often, a company will recall a dangerous or defective product itself without government prompting. Read more.
