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FDA asks Purdue Pharma to withdraw Palladone pain drug

–July 14, 2005

The FDA has asked Purdue Pharma to withdraw Palladone, its extended release pain management drug, from the market because of new information of serious and potentially fatal adverse reactions.

When Palladone is taken with alcohol the extended release mechanism is harmed and it can result in dose-dumping, a term describing the pill's ability to rapidly release the active ingredient from an extended release product into the blood stream. Because Palladone contains such a potent narcotic, dose-dumping even at the lowest marketed dose (12 mg.) can lead to potentially fatal events. The risk greatly increases when Palladone's dose also increases.

The latest data was gathered from a company-sponsored study testing the potential effects of alcohol use when mixed with Palladone, and because of what it revealed, the FDA asked Purdue Pharma to suspend all sales and marketing of the drug in the U.S. pending further discussions with the agency. According to Dr. Steven Galson, FDA Acting Director of the Center for Drug Evaluation and Research, "all powerful pain management drugs have serious risks if used incorrectly, but the current formulation of Palladone presents an unacceptably high level of patient risk."

So far, the FDA has not received any reports of serious problems, but Palladone has only been used in a relatively small number of patients, according to the agency. Palladone was approved in September 2004, and the agency was concerned as more patients took the drug safety problems would increase. According to Galson, "even having one alcoholic drink could have fatal implications."

Current drug labeling already includes standard opioid warning against the use of alcohol and Palladone, but the FDA believes the potential risks exceed what a warning label alone is able to convey. Patients currently taking Palladone should discuss treatment options with their individual physician.

For more information on the Palladone drug recall, please contact us to confer with an attorney.


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