FDA Asks Purdue Pharma to Withdraw Palladone for Safety Reasons

The US Food and Drug Administration has asked Purdue Pharma L.P. to voluntarily withdraw Palladone (hydromorphone hydrochloride) extended release capsules from the market. Palladone, if taken with alcohol, can result in rapid release of drug from the extended-release capsules. This can result in overdose with hydromorphone, and serious side effects, including slowed breathing (respiratory depression), coma, and even death.

Palladone is a long-acting, prescription pain medicine. Palladone contains the opioid (narcotic) pain medicine hydromorphone. The active ingredient, hydromorphone, has been available for pain relief for many years in other marketed drug products. Palladone is unique because the active ingredient, hydromorphone, is released slowly throughout the day, over 24 hours, so that it provides pain relief with once daily dosing. For more information on the FDA request, click here.

People currently taking Palladone should consult with their physicians for alternative treatments. Those who, on the advice of their physician, continue to take their current supply of Palladone should not drink alcohol, including beer, wine or distilled spirits, or take other prescription or over-the-counter-medicines that contain alcohol on days they take Palladone.

For additional information, please go to: http://www.fda.gov/cder/drug/infopage/palladone/default.htm