FDA Delay May Have Caused Thousands of Deaths
After decades of controversy over the painkilling drug propoxyphene, sold as Darvon and Darvocet, the FDA recently pulled it from the market. But new data shows that the agency’s delayed response may have been deadly for thousands of patients who took the drug.
The medical community expressed serious concerns over health risks associated with the drug for most of the 50 years that it was on the market. Studies show that the painkiller is not very effective, highly addictive, and toxic even at recommended levels.
The drug is so dangerous that the United Kingdom banned the drug in 2005 (the painkiller is also banned in the European Union). The consumer watchdog group Public Citizen found that at least 1,000 to 2,000 patient lives could have been saved if the FDA issued a ban around this time.
Public Citizen first petitioned U.S. regulators to remove the drug from the market back in 1978 when it determined that the drugs were dangerous and had few health benefits. The group again petitioned the agency in 2006, and filed a lawsuit in 2008 when the FDA did not act on its petition.
Now the group is calling for congressional hearings into FDA leadership to determine who is responsible for the agency’s delay in taking action.