FDA Removes Opioid Medication Opana ER from the Market because of Associated Abuse

June 26, 2017 | Strategic Insights for Ambulatory Care


​The U.S. Food and Drug Administration (FDA) requested that a manufacturer remove its opioid pain medication, reformulated Opana ER (extended-release oxymorphone hydrochloride), from the market because its therapeutic benefits no longer outweigh its risk for abuse. FDA states that its decision is "based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product's reformulation." FDA states that injection abuse of the drug is associated with a serious outbreak of HIV and hepatitis C virus infection, as well as cases of thrombotic microangiopathy, a serious blood disorder.

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