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July 15th, 2005

"Palladone pulled from the market after just five months"

The U.S. Food and Drug Administration has asked Purdue Pharma to stop the sale and marketing of its potent new pain drug, Palladone, after just five months on the market. The decision was made after the agency acquired new information regarding the interaction of alcohol that can cause potentially fatal effects by harming the extended release mechanism.

Palladone is a powerful narcotic that was approved for the management of persistent pain in patients requiring continuous, around-the-clock pain relief. Patients only have to take one capsule every 24-hours because of its time-release mechanism, but a company-sponsored study showed if mixed with alcohol the medication could leach out faster than intended, exposing the patient to high levels of the active ingredient.

Palladone’s active ingredient is hydromorphone, a Scheduled II controlled substance, which is the highest level of control for drugs with a recognized medical use. Purdue Pharma has asked the FDA to consider allowing the use of Palladone in institutional settings such as hospitals. The company also says it will try to reformulate the drug.

The FDA said while all powerful pain management drugs have serious risks if used incorrectly, Palladone’s risks are unacceptably high. Currently Palladone labeling already includes the standard opioid warning against the use of alcohol with the drug, but the agency did not believe the label warnings alone were sufficient considering the potentially fatal effects.

So far, no deaths or adverse reactions have been reported from Palladone’s interaction with alcohol. The FDA said the drug has been taken by a relatively small number of patients. Since it came on the market in February, roughly 11,500 patients have been prescribed the drug. The FDA said it was concerned safety problems would arise if more patients were prescribed the drug.

Purdue Pharma said it acted responsibly in launching Palladone.