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U.S. Department of Health and Human Services

Safety

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Palladone (hydromorphone hydrochloride)

Audience: Pain Specialists and other healthcare professionals

[Posted 07/14/2005] FDA issued a public health advisory to notify health care professionals and consumers 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. 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.

[July 13, 2005 - Public Health Advisory - FDA]
[July 13, 2005 - News Release - FDA]
[July 13, 2005 - Healthcare Professional Sheet - FDA]