FDA Requests Reformulated Oxymorphone Product Removed for Abuse Risk

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It was the first time the agency has taken steps to remove a now marketed opioid pain medication from sale due to the public health consequences of abuse, the FDA said. In 2015, CNN reported Opana became the choice of widespread substance abuse, which led to HIV and hepatitis C outbreaks, and some cases of a severe blood disorder called thrombotic microangiopathy. The FDA's reasoning was simple: the risks of the medication Opana ER outweigh the benefits, the agency said Thursday in a statement.

As public health authorities and the FDA became increasingly concerned about the nation's epidemic of opioid abuse and overdoses, the company reformulated the drug in 2012, by adding a coating that was meant to make it harder to snort or inject the medicine. Endo shares, which were up 11 percent at the close of the stock market, fell more than 12 percent in after-hours trading. "When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market", Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

"When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market", says Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

Endo has had other issues with the FDA and the drug.

The move comes after a panel of advisers concluded in March that the benefits of Opana ER, which was approved in 2006 and reformulated in 2012 to resist abuse, did not outweigh the risks. "When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market". The agency said that it would not allow the company to label the drug with language describing its potentially abuse-deterring properties, the statement said.

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The Centers for Disease Control and Prevention says opioid overdoses have hit record highs, killing more than 47,000 people in 2014 - more than the 32,000 who died in road accidents.

If the company declines to remove the product, the FDA will take steps to formally require its removal by withdrawing agency approval.

Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns".

"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak", said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

TRENTON, N.J. (AP) - U.S. regulators want a narcotic painkiller involved in the opioid epidemic off the market amid data showing people continue to abuse it. Opana ER last year generated sales of $158 million for the company, although that was down 10% from the year before.

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