Consumer group Public Citizen yesterday petitioned the US Food and Drug Administration to withdraw the leading painkiller Darvon and its generic versions from the market. The group said the drug was linked to more 2000 deaths, is highly addictive and less effective than safer alternatives that were available.
In its petition, the group explains that propoxyphene, selling under brand names such as Darvon, Darvocet, etc., is the 12th most commonly prescribed drug in the US. In 2004 alone, US pharmacies had filled a total of 23 million propoxyphene-based prescriptions. The drug is blamed for 2,110 - i.e. 5.6 percent of all drug-related deaths between 1981 and 1999.
When used, the drug gets converted into a highly toxic agent norpropoxyphene that stays longer in the system and causes the patient's heartbeat to slow. It can even cause cardiac depression, cardiac arrest or other complications, the group's petition said.
Competent physicians were aware of the drug's flaws and do not prescribe this drug, the group said. It had first urged the FDA to withdraw the same drug in the 1970s but the federal agency's inaction for so many years prompted the group to petition again.
They said the drug's withdrawal from the market should be gradual – in phases, to allow patients who use the drug enough time to switch to a safer alternative under the direction of their doctors. Many patients had already become dependent on the drug, the group said, and phasing out its withdrawal would ease the transition to another therapy.
The group cited similar withdrawal of the drug from the UK markets by the British government. Dr Sidney Wolfe, director of the group's Health Research division, said there was “no excuse for the drug to be around”.
The group supported its petition with autopsy statistics from the U.S. Drug Abuse Warning Network. The drug is particularly dangerous for the elderly as it affected their nervous system much like a sedative, which often resulted in the patient feeling confused and becoming prone to accidents like slipping and falling down, which can be fatal because of their fragile aging bones.
The drug was also linked to hundreds of suicides.
