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Palladone to be Withdrawn from the US Market

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Ten months after FDA approval and six months after marketing commencement, the FDA has asked Purdue Pharma to withdraw Palladone (extended-release hydromorphone hydrochloride capsules) from the US market.

Palladone is a potent narcotic used to control moderate to severe pain for persons requiring continuous analgesia for long periods of time. Palladone is not a "use as needed" pain medication.

The FDA issued its alert today based on evidence that even a small amount of alcohol combined with Palladone can alter the time release mechanism and allow a dangerous or fatal amount of medication to enter a patient's system.

For more information, please see the FDA News Article at FDA News - July 13, 2005