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