Xanodyne Pharmaceuticals, Inc. announced today that the company will voluntarily withdraw its Darvon®, Darvon-N®, and Darvocet-N®products from the U.S. market in consultation with the U.S. Food and Drug Administration(FDA).
This withdrawal is part of a market-wide withdrawal applying to all propoxyphene-containing products, affecting branded and generic pharmaceutical companies and a number of products on the market.
Propoxyphene is a mild opiate used for the treatment of mild-to-moderate pain and has been on the U.S. market for the last 50 years.
On January 30, 2009, a meeting of the FDA Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was convened to review the efficacy and safety of propoxyphene-containing products. Following that meeting, Xanodyne agreed to work together with the FDA, and took a number of steps including developing a patient medication guide, strengthening several of the warnings in the product labeling, and conducting a clinical study to assess the maximum tolerated dose and effects of propoxyphene on cardiac conduction.
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