SILVER SPRING, MD –
The fight against the opioid epidemic
in the United States took a major step forward. For the first time ever, the Food and Drug Administration requested that an opioid should be removed from the marketplace.
The FDA formally asked Endo, a pharmaceutical company, to stop selling Opana ER, an extended-release form of the opioid drug oxymorphone. The FDA said many users were crushing up and injecting the painkiller to abuse it, according to NBC News
“Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market,” the FDA said in a statement issued on Thursday (June 8). “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. 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.”
Endo acknowledged its drug could be used for the wrong reasons but pushed back at the notion that Opana ER should be completely removed from the market.
“While the benefits of opioids in treating and managing pain are widely recognized, the misuse and abuse of these products have increased greatly in the U.S,” Endo said in a press release. “As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products.
“Despite the FDA’s request to withdraw OPANA® ER from the market, this request does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that OPANA® ER has a favorable risk-benefit profile when used as intended in appropriate patients.”