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Suspended Marketing of Palladone (Hydromorphone Hydrochloride, Extended Release Capsules)

Jul 13, 2005 |

FDA is issuing this 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.

Purdue Pharma provided FDA data that showed that drinking alcohol while taking Palladone may cause rapid release of hydromorphone, leading to high drug levels in the body, with potentially fatal effects. High drug levels of hydromorphone may depress or stop breathing, cause coma, and even cause death.

FDA is announcing the following, effective immediately:

At FDA's request, Purdue Pharma has agreed to suspend sales and marketing of Palladone.

Patients being treated with Palladone should contact their physician to discuss appropriate alternative treatments, including immediate release hydromorphone.

Patients 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.

Any unused Palladone capsules should be disposed of safely by flushing them down the toilet.

Palladone is a time-release formulation of hydromorphone, a potent narcotic painkiller. Palladone is taken once-a-day and the capsule slowly releases a steady amount of hydromorphone into the body over that whole day. Palladone is approved for treatment of moderate to severe chronic pain only in opiate-tolerant patients (that is, patients who have been taking opiate containing products for a considerable period of time).

Palladone has been sold in the U.S. only since January 2005 and has been used only by a small number of patients. To date, FDA is not aware of any patients who have had life-threatening side effects from drinking alcohol while taking Palladone.

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