Opana ER is the FDA's newest target in the U.S. opioid painkiller epidemic and the agency has asked the drug's maker to pull the extended release form of oxymorphone from the market.
“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,” said an Food and Drug Administration statement.
The drug is an extended release form of the opioid oxymorphone manufactured by Endo Pharmaceuticals. It has been abused by being crushed up and snorted or injected by people, explained the FDA, which noted that “the benefits of the drug may no longer outweigh its risks.”
In a statement, Endo said it is reviewing the request, but maintains the drug’s safety and effectiveness. The request by the FDA “does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed,” Endo stated.
The FDA said it would withdraw approval of the medication if Endo doesn’t voluntarily take the drug off the market, CBS News reported.
“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,” said FDA Commissioner Dr. Scott Gottlieb.
FDA advisers reviewing the safety of Opana ER voted 18-8 against keeping it on the market during a March hearing, according to CBS News. Endo shares plummeted 13.4 percent in trading after the markets closed Thursday.
Opana ER has also been blamed for an outbreak of HIV and hepatitis C in southern Indiana because of shared needles in 2015.
Endo received approval for Opana ER in 2006. It attempted to put a reformulated version on the market in 2012, claiming the changes would reduce the possibility of abuse. But the FDA refused to allow its sale.
Although there are no generic versions of the reformulated Opana ER, there are generic versions of the original formula called oxymorphone ER on the market. However, the FDA is assessing information on those generic versions.
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