Palladone Extended Release Capsules (hydromorphone)

FDA ALERT [07/2005]:  Alcohol-Palladone Interaction

FDA has issued a public health advisory to inform patients and health care providers that the sponsor of Palladone, Purdue Pharma, has agreed to suspend sales and marketing of Palladone (hydromorphone hydrochloride, extended release capsules), a potent narcotic painkiller, because of the potential for severe side effects if Palladone is taken with alcohol.

Pharmacokinetic data indicate that the co-ingestion of Palladone and alcohol results in dangerous increases in the peak plasma concentrations of hydromorphone.  These elevated levels may be lethal, even in opioid tolerant patients.

• Public Health Advisory
• Healthcare Professional Sheet [PDF] [HTML]
• Questions and Answers

Background Information

FDA approved Palladone (hydromorphone hydrochloride extended-release) Capsules for the management of persistent, moderate to severe pain in patients requiring continuous, around-the-clock opioid analgesia with a high potency opioid for an extended period of time generally weeks to months or longer.
 

• FDA Talk Paper
• Approval Letter
• Label
• Medication Guide for Palladone

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Date created:   September 24, 2004, updated July 13, 2005

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