FDA requests Endo Pharmaceuticals pull Opana ER from the market

By Levin Simes
June 13, 2017

The Food and Drug Administration (FDA) has requested Endo Pharmaceuticals pull Opana ER from the market. Opana ER is an extended-release opioid, or narcotic. The drug is heavily abused by patients and can lead to addictions, which can then lead to overdoses and death.

The Center for Disease Control and Prevention (CDC) currently estimates nearly 100 Americans die daily from opioid addiction and addiction to prescription pain killers. Over 30,000 Americans died in 2015 according to CDC estimates.

Endo released Opana ER in 2012 in a prior effort to reduce abuse, but the FDA has determined the 2012 change was insufficient and the product is still too dangerous to be on the market. “This action will protect the public from further potential for misuse and abuse of this product”, said Janet Woodcock, the FDA’s director of Drug Evaluation and Research.

Endo Pharmaceuticals has released a statement: “Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward…Endo remains confident in the body of evidence established through clinical research demonstrating that OPANA® ER has a favorable risk-benefit profile when used as intended in appropriate patients.” Should Endo not remove the drug from the market voluntarily, the FDA may move withdraw approval of the drug, forcing the drug off the market formally.

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