
FDA Asks Endo to Remove Opioid From Market
FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
In an unprecedented statement, FDA asked Endo Pharmaceuticals to remove its opioid Opana ER (oxymorphone hydrochloride) from the market. In a June 8, 2017
Endo reformulated Opana ER in 2012 with the intention of making it resistant to the physical and chemical manipulation consistent with abuse. However, the agency said that data on the reformulated version of the drug did not appear to “meaningfully reduce abuse.” In addition, FDA said it has found that injection abuse of the reformulated Opana ER is associated with an outbreak of HIV and hepatitis C, as well as the blood disorder thrombotic microangiopathy.
In a March 2017 advisory meeting, the agency voted 18–8 that the benefits associated with Opana ER no longer outweigh the risks. If Endo does not take steps to remove Opana ER from the market, the agency said it intends to move to withdrawal its approval.
Endo responded in a
Newly appointed FDA Commissioner Scott Gottlieb, MD,
“We are facing an opioid epidemic–a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” Gottlieb said in a
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