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FDA Asks Drug Maker To Pull A Painkiller From Market For The First Time In History


Officials from the U.S. Food and Drug Administration (FDA) are ordering a pharmaceutical company to remove a painkiller from the market after reports of widespread abuse.

The request from the FDA Thursday told the company, Endo Pharmaceuticals, if they do not pull an extended release painkiller called Opana ER from the market the FDA will withdrawal approval of the drug. The threat is a first in FDA history and comes amid reports the pill is being crushed up and injected by people addicted to opioids, reports NBC News.

Representatives for Endo said they are evaluating the request but note the FDA provides no evidence challenging the safety of the painkiller when used as prescribed.

“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 said in a statement Thursday, according to NBC News. “This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.”

Endo Pharmaceuticals reformulated Opana ER in an attempt to make the painkiller more difficult to abuse in 2012, however FDA said the reformulation unintentionally fueled abuse of the drugs. The reformulation coated the pills in a way that made them difficult to snort, but addicts shifted towards crushing and injecting the painkiller.

Injection of the drug is reportedly causing an increase in viruses obtained through needle sharing.

“The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation,” the FDA statement said. “Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C.”

Drug overdoses are now the number one cause of death for Americans under 50 due to the national opioid epidemic. The New York Times recently culled through data from state health departments and county medical examiners and coroners, predicting there were between 59,000 and 65,000 drug deaths in 2016.

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