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Date 12/2010

Xanodyne Pharmaceuticals has agreed to withdraw DARVOCET and DARVON (propoxyphene), an opioid pain reliever used to treat mild to moderate pain, from the U.S market at the request of the FDA, due to the data showing that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. DARVOCET and DARVON have been removed from the market and are no longer available for resale effective 11/19/2010. Should you have any questions or require further information regarding the product withdrawal, the Xanodyne Medical Affairs department may be reached at 1-877-773-7793 or via email at ir@xanodyne.com. For further information, patients can call Xanodyne's medical information line at 1-877-773-7793 or visit www.xanodyne.com.

Advice for Healthcare Professionals

Stop prescribing and dispensing propoxyphene-containing products to patients.
Contact patients currently taking propoxyphene-containing products and ask them to discontinue the drug.

Inform patients of the risks associated with propoxyphene.

Discuss alternative pain management strategies other than propoxyphene with with your patients.

Be aware of the possible risk of cardiac conduction abnormalities (prolong QT, PR, and QRS intervals) in patients taking propoxyphene and assess patients for these events if they present with any signs or symptoms of arrhythmia.

Report any side effects with propoxyphene to FDA's MedWatch using the information at the bottom of the page in the "Contact Us" box.

Covered Alternative(s):


Acetaminophen-Codeine #3

Tramadole Tablets

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