FDA Asks Endo to Pull “Risky” Opioid Painkiller From Market

Kris Tripplaar, AP.

On Thursday, the Food and Drug Administration made an unprecedented move when it asked Malvern-headquartered Endo Pharmaceuticals to remove its opioid painkiller medication, Opana ER, from the market.

“After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks,” the FDA wrote in a statement.

The agency says its decision is based on a review of data, which revealed that users were abusing the reformulated Opana ER from nasal to injection. The agency also discovered injection abuse of Opana ER to be linked to an outbreak of HIV, hepatitis C and cases of thrombotic microangiopathy, a blood disorder, according to the FDA. In March, an advisory committee of the administration voted 18-8, determining that Opana ER was now too risky.

This decision marks the first time the agency has taken steps to remove an opioid pain medications from the market due to the public health consequences of abuse. The FDA’s announcement sent Endo’s shares down more than 12 percent on Thursday.

“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.

The FDA asked that Endo voluntarily remove Opana ER from the market, but the agency may have to come down harder on the company if it doesn’t comply. Endo said it is reviewing the FDA’s request to remove the drug that was first approved in 2006 for the management of moderate-to-severe pain. Endo replaced the original formulation of Opana ER in 2012 to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.

In a statement, Endo said it 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.”

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