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FILE - This Oct. 14, 2015 file photo shows the Food and Drug Administration campus in Silver Spring, Md. On Thursday, June 8, 2017, the FDA said it has asked Endo Pharmaceuticals to stop selling its reformulated, extended-release painkiller, Opana ER. (AP Photo/Andrew Harnik, File)

For the first time, the FDA is asking a drug company to pull an opioid from the shelves


The Food and Drug Administration has told a drug company to pull a powerful painkiller off the market because of its high potential for abuse. 

The FDA on Thursday asked Endo Pharmaceuticals to pull Opana ER pills, which it said were being crushed up and injected by people seeking to abuse the painkiller, CNN reported. 

This is the first time the FDA has requested an opioid be taken off the shelves and demonstrates the ongoing opioid epidemic in the U.S. 

"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," FDA Commissioner Dr. Scott Gottlieb said in a statement Thursday.

"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 FDA said its decision was based on post-market research showing a significant shift in abuse. People had been crushing up the pills and snorting them, but were increasingly injecting the drug. 

Injection of the drug was associated with a severe HIV outbreak in Indiana in 2015. 

In March, a group of independent experts on the FDA's advisory committee voted 18-8 that the benefits of the drug did not outweigh the risks of abuse. 

The company is pushing back, saying the drug is safe and effective, but the FDA says their decision is not up for discussion. If Endo doesn't voluntarily pull the drug, the FDA says it will withdraw approval for the painkiller. 

"Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward,” Endo said in a statement

“Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed," Endo said. 

The Centers for Disease Control and Prevention estimates more than 40,000 people died due to an opioid overdose in 2015. That's more than the number of people who died in car accidents that year. 

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