After documenting recent product abuse, the U.S. Food and Drug Administration asked Endo Pharmaceuticals to voluntarily remove its reformulated Opana ER (oxymorphone hydrochloride) opioid medication from circulation, stating that risks may now outnumber benefits.
The FDA noted this instance as the first of its kind: a request for removal of an already-marketed opioid pain medicine based on potential abuse. Agency research revealed an emerging pattern of injection abuse following Endo’s reformulation of the drug -- previously, misuse was more often characterized by nasal inhalation -- and a significant correlation in the rise of HIV and hepatitis C associated with use of the Opana ER product.
“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,” FDA Commissioner Dr. Scott Gottlieb said.
While Endo purposely reconfigured the product precisely to avert abuse, statistics showed that the new iteration nevertheless fell subject to consumer manipulation, thus coming under the government’s scrutiny. Agency officials elected to take action based on the inadvertently hazardous results.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Dr. Janet Woodcock, who leads the FDA’s Center for Drug Evaluation and Research, said. “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market. “This action will protect the public from further potential for misuse and abuse of this product.”