July 19, 2005

FDA ALERT

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA MedWatch - Palladone (hydromorphone hydrochloride) sales and marketing suspended because of the potential for severe side effects if Palladone is taken with alcohol.

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.

Read the complete MedWatch 2005 Safety summary, including links to the PHA,FDA press release, and supplemental information for healthcare professionals in the Q&A's and Healthcare Professional Information Sheet, at:

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Palladone