FDA seeks removal of opioid due to abuse risk
For the first time, the Food and Drug Administration has asked a drug manufacturer to remove a pain medication from the market over concerns of drug abuse.
On Thursday, the FDA asked Endo Pharmaceuticals to remove the opioid pain medication, Opana ER, from the market. In explaining the move, the agency said it believes the benefits of the drug may no longer outweigh the risk.
“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 Dr. Scott Gottlieb, in a news release. “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 decision came after data revealed a significant shift in how Opana ER was being abused – from nasal to injection. Injection abuse of the drug has been linked with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder, according to the FDA.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a news release. “This action will protect the public from further potential for misuse and abuse of this product.”
The FDA requested that Endo Pharmaceuticals voluntarily remove the drug from the market. Should the company choose not to, the FDA plans to take steps to formally require its removal by withdrawing the drug’s approval.
Opana ER was first approved in 2006 for the management of moderate to severe pain when a continuous opioid analgesic is needed for an extended period of time, according to the FDA.
In 2012, the company replaced the original formulation of Opana ER with a new formulation, intending to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. FDA data didn’t show that the reformulation could be expected to actually reduce abuse.
Now, with the information about the risks of the reformulated product, the agency is seeking the drug’s removal from the market.