Darvon and Darvocet Recall Injury Lawyers
On Friday, the FDA announced that Xanodyne Pharmaceuticals agreed to a voluntary recall of Darvon and Darvocet. These defective painkillers have been on the market for decades (Darvon was approved in 1957 and Darvocet in 1972) without any real evidence that they are effective for treating pain. Although many of the people who suffered Darvon injuries were also taking other drugs, the evidence indicates that these dangerous drugs may have been responsible for tens of thousands of deaths since their approval, and even more emergency room visits and long-term injuries.
If you have suffered injury or lost a loved one due to Darvon or Darvocet, you may be eligible to get compensation for your loss. To learn more, please contact a local Darvocet injury lawyer today.
Darvon and Darvocet: Not Proven Effective
Darvon was first approved for use in 1957. At that time, the Food, Drug, and Cosmetic Act only required that pharmaceuticals only be shown to be "safe" in the most basic sense to ensure approval. Darvon jumped this basic hurdle, and then survived a retrospective review by having had a couple of review articles published about it in the 1960s. (Because of their precedence, ease, and popularity, "Darvon" is used here instead of propxyphene and "Darvocet" is used instead of propoxyphene combined with acetaminophen.)
The first real review of the safety and effectiveness of Darvon came in 1971 when Eli Lilly & Company sought approval for "Darvon-N," propoxyphene napsylate, technically different (and therefore capable of being re-patented), but clinically equivalent to the original Darvon. The company was also seeking approval for pills that combined Darvon and acetaminophen (Tylenol). For the approval of these new variations, seven single-dose efficacy trials were submitted by Eli Lilly. These double-blind placebo trials showed mixed results, but five of the seven showed that there was no effect from Darvon. The only study showing significant results for Darvon showed it was about equivalent to acetaminophen, and another study said that Darvon plus acetaminophen were slightly superior to acetaminophen alone.
Because of the drug's near-ineffectiveness, 90% of the prescriptions written are for Darvocet, Darvon combined with acetaminophen. The Darvocet recall will stop the nearly 20 million prescriptions written for this drug annually.
Dangers of an Ineffective Drug
Studies in patients taking Darvon show that the drug affects the electrical signals controlling the beating of the heart. Studies showed that even at therapeutic doses, the drug resulted in deviations consistent with the development of irregular heartbeats. The effect increased over time and with dosage. It was this study that prompted the FDA to request a recall of Darvon and Darvocet.
Evidence suggests that the metabolite product of Darvon accumulates in the heart, and may be even more deadly to people with a specific genetic variation.
Darvon also inhibits a gene responsible for metabolizing other drugs, which means that it can make other drugs harder to metabolize and potentially more dangerous.
The dangers of Darvon injury are increased because the drug is ineffective. If a person takes a pain reliever and it does not work, they may take more than the recommended dose seeking relief. Darvon has a very narrow window of safety, and people who take additional pills are at a high risk for fatal overdose--according to one study, overdoses of Darvocet were 10 times more likely to be fatal than two other commonly used opioid pain relievers. People may also attempt to relieve lingering pain with alcohol, which has dangerous interactions with Darvon.
Darvon and Darvocet-Related Deaths
Because Darvon is most lethal in combination with other drugs, it has been hard to pin down exactly how deadly this drug is. The best indication comes from Florida, where the coroner's office actively lists all drugs involved in a person's death. According to the Florida coroner's reports Darvon, Darvocet, or generic equivalent:
- Caused 85 deaths in 2007
- Caused 71 deaths in 2006
- Was related to 341 deaths in 2007
- Was related to 328 deaths in 2006
Although it is difficult to extend these results to the overall population, it seems that these drugs may be the cause of thousands of deaths every year in the United States.
Compensation for Darvon Injuries
The current Darvocet recall is long overdue. The potential dangers of Darvocet have been known since at least 1979, when the FDA considered a petition to remove the drug on the basis of heart toxicity. However, manufacturers continued to produce and market the drug, endangering nearly 10 million users of the drug every year. Drug manufacturers are first and foremost responsible for the safety of their drugs and have a responsibility to act first on dangerous products like Darvon.
If you have lost a loved one due to a Darvon injury or another dangerous drug, seeking compensation is your way to strike back at companies that put profits above people. To learn more about your rights, please contact a local Darvon recall lawyer today.