FDA requests removal of opioid from Endo Pharmaceuticals

Drug has ties to HIV epidemic

For the first time, the US Food and Drug Administration has asked that a prescription opioid be pulled from the market due to "The Public Health Consequences of Abuse."

The agency's Commissioner says the risks associated with the drug outweigh the benefits.  The FDA wants a powerful opioid painkiller, Opana ER removed from the market.  The agency has asked Endo Pharmaceuticals to voluntarily pull the drug.  This is the first time the FDA has asked a company to remove a prescription opioid because of the public health risks of abuse.

An FDA market review prompted the decision.  It showed that abusers have mostly been injecting Opana ER since it was reformulated in 2012, and that has led to several public health problems.  Opana ER was at the center of an HIV outbreak in Indiana in 2015.  Needle sharing among users injecting the drug helped spread the HIV to more than 140 people.

Opana ER is also associated with a serious Hepatitis-C outbreak and cases of the blood disorder Thrombotic Microangiopathy.  The CDC says the US is suffering an epidemic of opioid overdoses.  More than 33,000 people died after overdosing on opioids in 2015, more than any year on record. 

Endo said in a statement that it is reviewing the FDA's request and will "Determine the appropriate path forward."  The FDA says it will withdraw approval for the drug if Endo doesn't pull Opana ER voluntarily.  

 


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