Proposyphene Withdrawal from US Markets

Tuesday, November 23, 2010 at 3:36:33 PM

Xanodyne, the manufacturer of propoxyphene products, and the FDA have agreed to remove propoxyphene containing products from the US market.

New clinical data has linked propoxyphene to potentially fatal heart rhythm abnormalities. The products effectiveness as a pain reliever is no longer enough to justify the side effect risks.

Suddenly stopping propoxyphene use in patients who have taken the drug for extended periods can lead to symptoms of withdrawal. At UHS, use of existing supplies of propoxyphene products is being restricted to continuation of existing therapy in order to avoid withdrawal symptoms. These patients should be advised to consult their prescribing practitioner ASAP to determine their options. All new orders (ie...patient is not routinely taking the product at home around the clock) will be referred to the prescriber for alternative therapy. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234389.htm


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