The FDA this week stopped the sale of a potent new pain drug, Palladone, after just five months on the market, over concerns that it could be dangerous or even fatal when taken with alcohol. The alcohol causes the narcotic in each pill to circulate in the body too quickly.
"People were receiving a full dose of this very powerful narcotic all at once," says FDA spokesperson Suzanne Trevino. "It could have side effects such as depressed breathing, leading all the way up to death."
Doctors have prescribed Palladone to roughly 11,500 patients since it came on the market in February, but so far no deaths or adverse reactions have been reported from the drug's interaction with alcohol, according to the drug's manufacturer, Purdue Pharma. The FDA requested that Purdue pull the drug based on research that the company provided to the FDA in November 2004.
The problem involves the interaction of alcohol and the time-release pellets in each pill. "Each pellet is its own long-acting delivery system," says Purdue public affairs director James Heins. "We did studies that showed, when you mixed alcohol and the pellet together, the alcohol caused the medication to leach out faster than intended."
Doctors in the United States had looked forward to using Palladone after the success of a similar drug in Canada. The FDA first approved Palladone, an extended-release form of the drug hydromorphone, for long-term pain management in September 2004. "Many people felt that an extended-release form of hydromorphone was going to be a useful drug," says Janet Abrahm, codirector of the Pain and Palliative Care Program at the Dana Farber Cancer Institute and Brigham and Women's Hospital in Boston.
"We try to help our cancer patients control their pain using whichever of these strong pain relievers cause them the fewest side effects," says Abrahm. "That's why it's helpful to have a number of different agents to choose from."
Still, doctors say Palladone wasn't on the market long enough to be missed. "The withdrawal of Palladone did not have the impact that Vioxx did, simply because it had only been in use for months," says V. Tim Malhotra, assistant attending anesthesiologist at Memorial Sloan-Kettering Cancer Center in New York.
Purdue Pharma has asked the FDA to consider allowing the use of Palladone in institutional settings such as hospitals. The company says it will also try to reformulate the drug.