A First: FDA Calls for Opioid’s Removal from Market

For the first time, the FDA is asking for the removal from the market of a prescription opioid medication over abuse concerns.

The active ingredient in the drug, Opana ER (extended release), is oxymorphone, which is closely related to morphine. The drug was reformulated in 2012 in an attempt to make it more difficult to abuse. Despite this, the FDA says it has received reports of people crushing the drug, dissolving it and then injecting it. This led to an outbreak of HIV and hepatitis C in 2015 in Southern Indiana. There are also cases of some abusers of Opana ER contracting a serious blood disorder.

The FDA said it made its decision because of “its concern that the benefits of the drug may no longer outweigh its risks.” In March, an FDA advisory committee voted 18-8 agreeing with that position.

In a statement, Endo said it is reviewing the request and is considering its options. The company maintains that Opana ER “has a favorable risk-benefit profile when used as intended in appropriate patients.”

If Endo does not pull Opana ER from the market, the FDA says it will begin a process that will remove the drug’s approval.

Jonathan Block

Jonathan Block

Jonathan Block is a freelance writer and former MedShadow content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including BioCentury, The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.

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