On November 19, the FDA finally announced Xanodyne Pharmaceuticals had decided to voluntarily withdraw Darvon and Darvocet (Darvon plus acetaminophen). Studies have shown that even small doses Darvon and Darvocet alter the electrical impulses that control the heart, putting people at an increased risk for arrhythmia and other dangerous heart conditions.
Darvon and Darvocet are weak opioid painkillers, and their withdrawal is long overdue because they have never been shown to be effective. Darvon (propoxyphene) was originally approved in 1957 when the Food, Drug, and Cosmetic Act only required that drugs be shown to be “safe”–i.e. not immediately lethal–before approval. Therefore, no tests were done initially to confirm its effectiveness. A retroactive review of effectiveness was conducted when the law changed, and the drug survived based on two very weak review articles. When Eli Lilly sought in 1971 to market a variation on Darvon (Darvon-N) and introduce Darvocet. To get this approval, it submitted double-blind placebo trials on the drug. Five of the seven submitted studies showed there was no effect from Darvon. Only one study showed that Darvon alone was effective, about the equivalent of acetaminophen. Another study showed that Darvon was ineffective when used alone, but when used in combination with acetaminophen the two drugs together were slightly more effective than acetaminophen alone.
Although they are relatively ineffective pain relievers, Darvon and Darvocet are dangerous drugs. They can have dangerous interactions with other drugs and alcohol. Because Darvon and Darvocet often work in combination with other drugs, it is unknown how many people may have been killed by them. What are considered the best estimates for these drugs’ effects come from Florida, where the state coroner reports on multiple drugs that may have contributed to a person’s death in addition to the single drug that may be pointed to as the actual cause of death. According to the coroner’s figures, in 2007 alone Darvon, Darvocet, or generic equivalent, contributed to 341 deaths and “caused” 85 deaths. Extrapolating these figures to the US population says it is likely that thousands of people every year have died as a result of Darvon use with only minimal–if any–benefits.
If you have suffered heart problems or lost a loved one due to wrongful death by these defective drugs, you may be eligible for compensation for your injuries. The product liability lawyers of Robert W. Kerpsack, CO, LPA of Columbus, Ohio stand ready to help. To learn how we can help, please contact us today for a free consultation.