![]() ![]() “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.” ![]() “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 Scott Gottlieb. The FDA’s June 2017 request came after a group of independent experts met in March and voted 18-8 that the benefits of reformulated Opana ER no longer outweigh the risks. Injection abuse of the drug has been associated with an outbreak of HIV and hepatitis C, as well as a serious blood disorder. “Endo plans to work with FDA to coordinate the orderly removal of Opana ER in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their healthcare professionals,” the company said in a statement.ĭespite its decision to remove the drug, Endo said it “continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended.”Īfter Opana ER was reformulated in 2012, the FDA said abusers began injecting it more than snorting it. ![]() Read more: 10 of the best children’s hospitals in America Opana ER pulled from the market at FDA request One month after the FDA’s request, Endo Pharmaceuticals said it has decided to voluntarily stop selling the powerful drug. Opana ER, an opioid pain medication, is being pulled from the market because of abuse after a first-of-its-kind request from the Food and Drug Administration. ![]()
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