July 14, 2005 - Purdue Pharma has voluntarily taken its pain-relieving Palladone capsules off the market, the drugmaker says in a news release.
The company took the action on July 13 following an FDA request to withdraw Palladone because of safety concerns.
The FDA approved Palladone in September 2004. The drug was launched by Purdue Pharma this February.
Palladone was approved for the management of persistent, moderate-to-severe pain in patients requiring continuous, around-the-clock pain relief with a high-potency opioid for an extended period of time, states a Purdue Pharma news release.
Patients taking Palladone should consult their doctors about alternative treatments, states an FDA news release.FDA's Statement
An FDA news release states that "serious and potentially fatal adverse reactions can occur when Palladone (hydromorphone hydrochloride) extended release capsules are taken together with alcohol."
According to the FDA news release, "Palladone is a once-a-day pain management drug containing a very potent narcotic. New data gathered from a company-sponsored study testing the potential effects of alcohol use shows that when Palladone is taken with alcohol the extended release mechanism is harmed which can lead to dose-dumping."
Dose-dumping, the FDA says, is the rapid release of the drug's active ingredient into the bloodstream. The agency's news release says dose-dumping, even with a low dose of Palladone (12 milligrams), could lead to "serious, or even fatal, adverse events in some patients."
The FDA warns that the risk increases for higher doses of Palladone.
The FDA says Purdue Pharma has greed to suspend the sale of Palladone in the U.S. until the company discusses safety issues with the agency.
"All powerful pain management drugs have serious risks if used incorrectly, but the current formulation [extended release capsules] of Palladone presents an unacceptably high level of patient risk," says Steven Galson, MD, MPH, FDA acting director of the Center for Drug Evaluation and Research, in the news release.
"Although we have not received reports of serious problems, this product has so far been used in a relatively small number of patients. We are concerned that as more patients take this drug, safety problems will arise since even having one alcoholic drink could have fatal implications," continues Galson.
According to the FDA, Palladone's current label already has a standard opioid warning about the use of alcohol and Palladone. But the FDA release notes that the agency doesn't believe that "potentially fatal, adverse events can be effectively managed by label warnings alone. ..."
Purdue Pharma's Statement
Purdue Pharma's news release states that the company has "implemented a plan to reformulate Palladone capsules to reduce the risk of an alcohol interaction with the product."
The release also states that the FDA has "agreed to entertain a proposal for use of Palladone Capsules in certain institutional settings, such as hospitals and in-patient hospices, and the company is reviewing whether such a limited distribution would be feasible."
"Purdue is not aware that the concomitant use of alcohol and Palladone has caused injury to any of the approximately 11,500 patients for whom the medicine has been prescribed," states the release.
"Palladone was launched by Purdue with clear and strong warnings about alcohol interaction. Purdue believed these warnings, and modifications to our Risk Management Program, appropriately addressed this risk. Yesterday, the FDA advised Purdue that it has concluded that the risk of alcohol interaction cannot be adequately managed with warnings," the statement continues.
"We acted responsibly and worked closely with the FDA in launching Palladone on a limited basis with a rigorous risk management program, and in the discussions that led to the decision to suspend marketing of the product," says Michael Friedman, Purdue Pharma's president and CEO, in the release.