United States

FDA Asks Drug Company to Pull Its Opioid Opana Because of Abuse

The company is pushing back, saying the drug is safe and effective. The FDA says if Endo doesn’t voluntarily pull the drug from the market, it will withdraw approval

The Food and Drug Administration has asked Endo Pharmaceuticals to remove Opana ER, an extended release form of the opioid drug oxymorphone made by the drug company, from the market because it has such a high potential for abuse.

"This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse," the FDA said in a statement.

The company is pushing back, saying the drug is safe and effective. The FDA says if Endo doesn’t voluntarily pull the drug from the market, it will withdraw approval.

The Centers for Disease Control and Prevention says opioid overdoses have hit record highs, killing more than 47,000 people in 2014 — more than the 32,000 who died in road accidents.

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