United States of America - On request of the Food and Drug Administration (FDA), the sponsor of hydromorphone hydrochloride (Palladone®) extended release capsules, a potent narcotic painkiller, has agreed to suspend sales and marketing because of the potential for severe side effects if taken with alcohol.

Data has been provided to show that alcohol can cause high hydromorphone levels in the body, with potentially fatal effects. High drug levels of hydromorphone may depress or stop breathing, cause coma, and even death. Patients should contact their physician to discuss appropriate alternative treatments, including immediate release hydromorphone.

Palladone® is a time-release formulation of hydromorphone, a potent narcotic painkiller taken once-a-day with the capsule slowly releasing a steady amount of hydromorphone into the body. Hydromorphone is approved for treatment of moderate to severe chronic pain in opiate-tolerant patients and has been sold in the USA only since January 2005. To date, FDA is not aware of any patients who have had life-threatening side effects from drinking alcohol while taking hydromorphone.

Reference: FDA Public Health Advisory 13 July 2005. http://www.fda.gov/cder