In a first, the US FDA requested that Opana ER (oxymorphone hydrochloride), an opioid painkiller, be voluntarily removed from the market. The FDA based this decision on the drug’s capacity for abuse, and that its mode of administration (injection) has been linked to transmission of diseases like HIV and hepatitis C.
“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 Scott Gottlieb, FDA Commissioner. “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.”
The opioid is manufactured by Endo Pharmaceuticals, and was approved over a decade ago for the treatment of moderate or severe chronic pain. The potent extended-release formula proved effective at relieving pain, but also quite dangerous for misuse. Following these criticisms, Endo reformulated the drug in 2012, supposedly making the drug more difficult to abuse.
However, the FDA determined that the reformulation did not “meaningfully reduce abuse.” Specifically, it seems that the drug is now being abused by injection rather than snorting. And this mode of abuse has been linked to outbreaks of HIV and hepatitis C via contaminated needles. In addition, abuse of Opana ER has been linked to another serious blood disorder, known as thrombotic microangiopathy.
"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak," said Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, in a statement.
"When we determined that the product had dangerous and unintended consequences, we made a decision to request its withdrawal from the market," said Woodcock. "This action will protect the public from further potential for misuse and abuse of this product.”
The FDA’s polite request may make it appear as though Endo Pharmaceuticals could have a say in whether or not to comply. In actuality, if the company does not voluntarily pull its product off the shelf, the FDA will more than likely revoke their approval and force the drug off the shelf.
Endo responded to the request, saying that the company is “reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward." Furthermore, the company defended their drug’s efficacy at relieving pain. "As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo feels a strong sense of responsibility to improve the care of pain for patients, while at the same time taking comprehensive steps to minimize the potential misuse of its products.”
Additional source: Live Science