OxyContin manufacturer pleads guilty to misbranding and misrepresenting product
May 11, 2007
Purdue Frederick pled guilty to criminal and civil charges over the misbranding of OxyContin (oxycodone extended-release) and agreed to pay a $600 million settlement. The charges were connected to illegal schemes to promote, market, and sell OxyContin. The Purdue sales force was trained to make false claims to healthcare providers that OxyContin is less addictive, has lower abuse potential, and causes less tolerance and withdrawal than other narcotic pain medications. Purdue also provided false information in the package insert about the product’s pharmacokinetics and abuse potential. These practices are considered misbranding by falsely promoting OxyContin’s benefits and potentially causing harm to consumers.
Additional information is available at the following links:
MedWatch alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical...
FDA Press Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108913.htm
Updated
May 11, 2007; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
Purdue Frederick pled guilty to criminal and civil charges over the misbranding of OxyContin (oxycodone extended-release) and agreed to pay a $600 million settlement. The charges were connected to illegal schemes to promote, market, and sell OxyContin. The Purdue sales force was trained to make false claims to healthcare providers that OxyContin is less addictive, has lower abuse potential, and causes less tolerance and withdrawal than other narcotic pain medications. Purdue also provided false information in the package insert about the product’s pharmacokinetics and abuse potential. These practices are considered misbranding by falsely promoting OxyContin’s benefits and potentially causing harm to consumers.
Additional information is available at the following links:
MedWatch alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical...
FDA Press Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108913.htm
Updated
May 11, 2007; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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