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Opana Risks Outweigh Benefits

March 15, 2017

An independent panel to the U.S. Food and Drug Administration (FDA) concluded on Tuesday, March 14, 2017 that the benefits of Endo International Plc's  Opana no longer outweigh its risks. The panel convened to address the high abuse rate of Endo's Opana ER and other OxyMorphone formulations. The FDA is looking to stem the tide of opioid abuse, overdose, and addiction.  Deaths involving opioids have catapulted in recent years to an average of 91 opioid overdoses per day in the United States, per the Centers for Disease Control and Prevention.


Endo's Opana ER was initially approved in 2006 as a long-acting variation of OxyMorphine. Its intended use was to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment. By 2012, a new formulation of Opana ER was designed to deter snorting or oral abuse. With the new formulation, nasal abuse has reduced, but intravenous abuse has increased. The panel is concerned with the increased rates of certain rare blood disorders and HIV that are linked to the shift from nasal abuse to intravenous.



Source: Reuters via FoxNews.com

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