Update: One month after the FDA's withdrawal request, pharmaceutical company Endo has chosen to voluntarily remove Opana ER, an opioid prescription the FDA deemed too risky to warrant the benefits, from the market. Endo, however, "continues to believe in the safety, efficacy, and favorable benefit-risk profile of OPANA® ER when used as intended," the company said in a press release.
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Opana ER (oxymorphone hydrochloride) has been deemed too risky for use, as the agency feels that the health risks of the drug outweigh its possible benefits.
“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,” FDA commissioner Scott Gottlieb, M.D., said in the statement.
Opana ER was linked to an outbreak of HIV in Indiana in 2015, as addicts were reformulating the drug into an injectable and sharing needles. This came after Endo Pharmaceuticals, the company that makes Opana ER attempted to make the drug less risky by using a coating that was hard to crush — and therefore making it more difficult for addicts to snort.
In the statement, the FDA said that these safety measures weren't enough.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak," Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in the statement. "When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market."
For now, the agency has requested that Endo Pharmaceuticals voluntarily remove the drug from the market, but says they are prepared to require its removal if the company fails to do so.
While it may seem like a small move, given that there are other opioid medications still available, doctors seem to think that the FDA being willing to discontinue a medication in order to reduce risk of opioid abuse could have a major impact.
"My comment is 'wow,'" Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University, told CNN. "This is pretty exciting. This is big news."
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