Friday, 13 Jul 2018

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FDA Requests Removal of OPANA-ER from the Market

The U.S. Food and Drug Administration has asked Endo International to withdraw Opana ER from the market, stating that benefits no longer outweigh its risks of this long-acting opioid.

A March 2017 advisory committee concluded that Opana ER, is not safe, and many have called for its removal.

Opana ER is twice as potent as oxycodone and has a high abuse potential when crushed and taken for a massive high effect by addicts.  

The drug was approved in 2006, but attempts by the manufacturer in 2012 to make it harder to tamper with, lead some to either inject or snort the drug for immediate effects. This method of delivery also lead to outbreaks of HIV and hepatitis C and thrombotic microangiopathy. 

This action follows the approval of the opiods that possess greater abuse-deterrent properties.

Should Endo not voluntarily withdraw the product, it is presumed the FDA will take further action to remove it.

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

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