The FDA is requesting Endo Pharmaceuticals remove Opana ER (oxymorphone hydrochloride) from the U.S. market because they believe the drug’s risks outweigh its benefits.
“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, M.D. “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.”
Opana ER has recently been reformulated, and data shows abusers of the drug are now injecting it instead of administering it nasally. Injection of the drug has been associated with a serious outbreak of HIV, hepatitis C and a serious blood disorder (thrombic microangiopathy.)
As it stands, the FDA is requesting Endo to voluntarily remove the drug from the market. Should the company choose not to remove the product, the FDA will take steps to withdraw approval of Opana ER.