Food and Drug Administration‬‬
‪‪Food and Drug Administration‬‬

FDA requests removal of Opana ER for risks related to abuse

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In the present day, the U.S. Meals and Drug Administration requested that Endo Prescription drugs take away its opioid ache medicine, reformulated Opana ER (oxymorphone hydrochloride), from the market. After cautious consideration, the company is searching for elimination based mostly on its concern that the advantages of the drug could not outweigh its dangers. That is the primary time the company has taken steps to take away a at the moment marketed opioid ache treatment from sale as a result of public well being penalties of abuse.

‪‪Food and Drug Administration‬‬

“We face an opioid epidemic – a public well being disaster, and we should take all obligatory steps to cut back the scope of opioid misuse and abuse,” mentioned FDA Commissioner Scott Gottlieb, M.D. “We are going to proceed to take regulatory steps once we see conditions the place an opioid product’s dangers outweigh its advantages, not just for its supposed affected person inhabitants but additionally in regard to its potential for misuse and abuse.”

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‪‪Food and Drug Administration‬‬

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