What takes FDA so long to ban Darvon?

The Food and Drug Administration said Nov 19 that it has requested two popular painkillers, Darvon and Darvocet, to be withdrawn from the U.S. because of safety issues. 

Xanodyne Pharmaceuticals, the manufacturer of these painkillers, indicated it will comply with the agency's request and stop selling Darvon, which contains a risky ingredient. 

These painkillers are made of an opioid called propoxyphene, which is also used in generic painkillers.  The agency requested manufacturers of such generics to withdraw their products as well. 

Using propoxyphene-based pharmaceutical drugs like Darvon and Darvocet has been linked with elevated risk of potentially serious or even fatal heart rhythm abnormalities. 

The FDA said it decision to ban Darvon and Darvocet came after a review of trials of propoxyphene, which are consistent with those from epidemiological studies showing that patients using the drug were at higher risk of serious adverse effects. 

An estimated 10 million Americans are currently Darvocet and other propoxyphene painkillers, according to webmd.com.  

The FDA suggested that patients on the drugs contact their physicians for alternative pain treatment, but should not immediately stop taking them because withdrawal symptoms can be serious. 

"Don't delay," Gerald Dal Pan, MD, MHS, director of the FDA's office of surveillance and epidemiology was quoted as saying. 

It is ironic, however, that the wording resounds with such a sense of urgency. 

Propoxyphene was approved by the FDA in 1957.  The Public Citizen petitioned to the FDA in 1978 and again in 2006 to ban the painkillers because of the risk associated with taking the drugs. 

According to webmd.com, the United Kingdom banned the drug six years ago and the European drug agency banned it one and half a year earlier. 

Only the second petition of the public Citizen led the FDA to convene its expert advisory committee, which eventually recommended a ban in July 2009. 

The FDA took an unusual step and did not ban the drug immediately. Instead, it asked the drug maker to submit a review of studies of the drug's adverse effects on the heart, which led to the current ban, Webmd reported. 

Public Citizen complained that the FDA has waited for too long to protect the public.   

"Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since the time the U.K. ban was announced," said Sidney Wolfe, director of Public Citizen's health research group, in a press release. 

Wolfe was cited as saying Public Citizen will ask Congress to conduct an instigation to find out who was responsible for the loss of so many lives in this country.

Jimmy Downs and editing by Rachel Stockton