(WTXL) - The the U.S. Food and Drug Administration is requesting that a pharamaceutical company remove it's opioid pain medication due to concern that the benefits of the drug may no longer outweigh its risks.
They have asked for Endo Pharmaceuticals to remove the reformulated Opana ER from the market.
“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, M.D. “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.”
Back in 2012, the company reformulated the drug to make it harder to crush. But the FDA says data suggests that the reformulation did little to stop the abuse.
They said that the decision was made after they reviewed data that suggested a significant increase in the amount of people injecting Opana ER versus nasal use as before.
The injection abuse has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy).
Opana ER is about twice as strong as OxyCotin, another often abused opioid.
Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid is needed for an extended period of time.
The FDA approved it for this use in 2006.
The FDA says that should the company choose not to remove the product, they intend to take steps to remove it by withdrawing approval.
