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Palladone

The FDA asked Purdue Pharma to immediately discontinue sales and marketing of its new potent pain drug Palladone because of concerns it could have serious, even fatal, consequences if taken with alcohol. Doctors in the United States had looked forward to the use of Palladone after the success of a similar drug in Canada, but the agency acquired information from a company-sponsored study showing the drug's extended release mechanism is harmed if taken with alcohol, which can lead to dose-dumping.

Dose-dumping means people were receiving a full dose of Palladone all at once because alcohol injures the extended release mechanism, allowing the active ingredient in Palladone to get into the bloodstream. Palladone's active ingredient, hydromorphone, is a Scheduled II controlled substance, or the highest level of control for drugs with a recognized medical use. Based on the risks associated with Palladone, the FDA worked with Purdue Pharma to develop a comprehensive risk management program before its drug approval, but later concluded in light of what the study revealed that it was not sufficient.

According to Purdue Pharma's statement following the recall announcement, the company believed the warnings and modifications to its risk management program appropriately addressed the risks regarding alcohol interaction. Palladone entered the market in February 2005, and before it was even on the market six months, the agency asked Purdue Pharma to withdraw the drug on July 13, 2005. The FDA was concerned that as more patients were prescribed Palladone reports of safety problems would arise since the drug was only used in a relatively small number of patients.

Palladone labeling already included the standard opioid warning against the use of alcohol and Palladone, but because even one alcoholic drink could have fatal implications, the FDA did not believe Palladone's significant risk factors could be effectively managed by label warnings alone and a risk management plan. Purdue said the FDA did agree to "entertain a proposal for use of Palladone Capsules in certain institutional settings, such as hospitals and in-patient hospices."

Approximately 11,500 patients were prescribed Palladone during its short stay on the market, according to Purdue Pharma, and while the FDA said it had not received reports of serious problems because of alcohol interactions, the agency believed Palladone had an "unacceptably high level of patient risk." Palladone came in 12, 16, 24 and 32-milligram capsules, but the FDA said even with a low 12 mg. dose of Palladone some patients could suffer potentially fatal adverse events. When drug dose increased, Palladone patients were at an even higher risk for suffering serious adverse events.

Doctors say Palladone was not on the market long enough to be missed, but the withdrawal was disappointing to Purdue Pharma because of the recent loss of its patent protection on another powerful drug OxyContin. Palladone was one of a couple new drugs on Purdue's portfolio, but at the time of the withdrawal announcement, the company said it implemented a plan to reformulate the drug capsules to reduce the risk of an alcohol interaction.

The FDA advised all Palladone patients to consult with their physicians for alternative treatments.

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