The FDA has asked Purdue Pharma to withdraw hydromorphone HCl (Palladone™) for safety reasons after learning that serious and potentially fatal adverse reactions can occur when the extended-release capsules are taken with alcohol.
Palladone™, a once-daily drug for pain management, contains a potent narcotic. A new study shows that alcohol can damage the extended-release mechanism, possibly resulting in the rapid release of the active ingredient into the bloodstream.
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The consequences of this “dose dumping” at the lowest marketed dose (12 mg) may lead to adverse events in some patients. The risk is even greater for the higher strengths of the product.
The current labeling for Palladone™, approved in September 2004, already includes the standard opioid warning against the concomitant use of alcohol.
The company agreed to suspend sales of the product in the U.S. pending further discussions with the FDA.
Patients taking Palladone™ should consult their physicians for alternative treatments.