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F.D.A. Asks Drug Maker to Stop Selling a Dangerous Opioid F.D.A. Asks Drug Maker to Stop Selling a Dangerous Opioid
(8 days later)
On Thursday, for the first time in its history, the Food and Drug Administration asked a drug company to take an opioid medication off the market. On Thursday, for the first time in its history, the Food and Drug Administration asked a drug company to take an opioid medication off the market because of concerns about drug abuse.
The drug, Opana ER — a form of the painkiller oxymorphone hydrochloride — has been heavily abused and linked to outbreaks of H.I.V., hepatitis C and a serious blood disorder among people who crush the pills into powder and inject it.The drug, Opana ER — a form of the painkiller oxymorphone hydrochloride — has been heavily abused and linked to outbreaks of H.I.V., hepatitis C and a serious blood disorder among people who crush the pills into powder and inject it.
The move by the F.D.A. may signal a more aggressive approach against prescription opioids that are found to be widely abused.The move by the F.D.A. may signal a more aggressive approach against prescription opioids that are found to be widely abused.
“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,” Dr. Scott Gottlieb, the F.D.A. commissioner, said in a statement released by the agency. He added that the F.D.A. would continue to “take regulatory steps” against products fueling the epidemic.“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,” Dr. Scott Gottlieb, the F.D.A. commissioner, said in a statement released by the agency. He added that the F.D.A. would continue to “take regulatory steps” against products fueling the epidemic.
The drug’s maker, Endo Pharmaceuticals, responded with a statement saying that it was reviewing the request and “evaluating the full range of potential options as we determine the appropriate path forward.” Endo has global headquarters in Dublin and United States headquarters in Malvern, Pa.The drug’s maker, Endo Pharmaceuticals, responded with a statement saying that it was reviewing the request and “evaluating the full range of potential options as we determine the appropriate path forward.” Endo has global headquarters in Dublin and United States headquarters in Malvern, Pa.
If Endo does not take the drug off the market, the F.D.A. “intends to take steps to formally require its removal by withdrawing approval,” the agency said in its news release.If Endo does not take the drug off the market, the F.D.A. “intends to take steps to formally require its removal by withdrawing approval,” the agency said in its news release.
Opana ER is an extended-release painkiller that was first approved in 2006. Drug users began to crush it so they could snort it or inject it to get high.Opana ER is an extended-release painkiller that was first approved in 2006. Drug users began to crush it so they could snort it or inject it to get high.
In 2012, Endo replaced the original version with a new formulation that was meant to thwart abuse by making the pills resistant to crushing and dissolving in liquid for injection.In 2012, Endo replaced the original version with a new formulation that was meant to thwart abuse by making the pills resistant to crushing and dissolving in liquid for injection.
Users found ways to inject the drug anyway, and the problems worsened after the new formulation was introduced, an F.D.A. spokeswoman said.Users found ways to inject the drug anyway, and the problems worsened after the new formulation was introduced, an F.D.A. spokeswoman said.
She said generic forms of the original version were still available, and the F.D.A. is looking at abuse patterns of those drugs to determine whether they, too, should be taken off the market.She said generic forms of the original version were still available, and the F.D.A. is looking at abuse patterns of those drugs to determine whether they, too, should be taken off the market.
Dr. Gottlieb said in an interview that trying to end the opioid epidemic “will continue to be one of my highest priorities, if not my highest priority.”Dr. Gottlieb said in an interview that trying to end the opioid epidemic “will continue to be one of my highest priorities, if not my highest priority.”