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FDA Recalls Recalled - July 13, 2005

Approved-By: FDA.Recalls@FDA.GOV

FDA Asks Purdue Pharma to Withdraw Palladone for Safety Reasons

( http://www.fda.gov/opacom/Enforce.html ).

FOR IMMEDIATE RELEASE
P05-42
July 13, 2005
Media Inquiries:
Suzanne Treviño,
Consumer Inquiries:

FDA Asks Purdue Pharma to Withdraw Palladone for Safety Reasons After acquiring new information that serious and potentially fatal adverse reactions can occur when Palladone (hydromorphone hydrochloride) extended release capsules are taken together with alcohol, the U.S. Food and Drug Administration has asked Purdue Pharma L.P., the makers of the drug, to withdraw it from the market.

Palladone is a once-a-day pain management drug containing a very potent narcotic. New data gathered from a company-sponsored study testing the potential effects of alcohol use shows that when Palladone is taken with alcohol the extended release mechanism is harmed which can lead to dose-dumping.

Dose-dumping is a term that describes the rapid release of the active ingredient from an extended release product into the blood stream. The consequences of dose dumping at the lowest marketed dose (12 mg.) of Palladone could lead to serious, or even fatal, adverse events in some patients and the risk is even greater for the higher strengths of the product. As a result of this potential serious safety risk, the FDA has asked Purdue Pharma, and they have agreed, to suspend all sales.

Next Palladone Story.

Marketing of Palladone in the U.S. pending further discussions with the agency

"All powerful pain management drugs have serious risks if used incorrectly, but the current formulation of Palladone presents an unacceptably high level of patient risk" said Dr. Steven Galson, FDA Acting Director of the Center for Drug Evaluation and Research. "Although we have not received reports of serious problems, this product has so far been used in a relatively small number of patients. We are concerned that as more patients take this drug, safety problems will arise since even having one alcoholic drink could have fatal implications."

The current labeling for Palladone, approved in September, 2004, already includes the standard opioid warning against the use of alcohol and Palladone. However, the FDA does not believe that the risk of serious, and potentially fatal, adverse events can be effectively managed by label warnings alone and a risk management plan.

Patients currently taking Palladone should consult with their physicians for alternative treatments. For additional information, please go to:

http://www.fda.gov/cder/drug/infopage/palladone/default.htm

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