For the first time, the Food and Drug Administration (FDA) is seeking to ban a previously approved opioid due to its addictive qualities. In this decision, the FDA specifically recognized the public health risk of the opioid epidemic and committed to making other similar evaluations with other drugs.
On June 8, 2017, in an unprecedented move, the FDA requested Endo Pharmaceuticals take one of their opioid pain medications—reformulated Opana ER (oxymorphone hydrochloride)—
The FDA explained in a statement: “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.”
“My comment is ‘wow,'” according to Dr. Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University. “This is pretty exciting. This is big news.”
In response to the abuse, Endo replaced the formula for Opana ER in 2012, seeking a label that described “abuse deterrent properties” from the FDA. The FDA approved the new version of the drug, but denied the new labeling because there was insufficient evidence to
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