The Food and Drug Administration has asked Endo Pharmaceuticals to stop selling its Opana ER painkiller because officials think it’s too easy to abuse, STAT reports. This is the first time the FDA has asked for an approved drug to be pulled off the market for its abuse potential.
The FDA announced Thursday it made the request after examining data after Opana ER’s approval in 2006. Endo reformulated Opana ER in 2012 in an attempt to prevent unauthorized users from crushing and snorting the pills. But users simply shifted to cooking and injecting the pill, according to FDA data. In 2015, 135 residents of Austin, Indiana—a city with a population of just 4,200—contracted HIV from sharing needles. All of the 112 affected individuals interviewed by the Centers for Disease Control and Prevention said they injected Opana ER.
Endo appears to be preparing its opposition to the FDA’s request, STAT reports. The FDA announcement states that, if Endo doesn’t comply voluntarily, “the agency intends to take steps to formally require its removal by withdrawing approval.”
