Endo Pharmaceuticals is being asked by the Food and Drug Administration (FDA) to remove its Opana ER opioid pain medication.
This marks the first time the regulatory agency has taken steps to remove a drug from the market due to risks of abuse, according to a press release.
“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 in the FDA’s announcement. “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."
According to the FDA, the decision to remove Opana was a review of post-marketing data, which showed a significant shift toward abuse from nasal injection of the drug after the product’s reformulation.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said. “This action will protect the public from further potential for misuse and abuse of this product.”