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Drug Maker Buckles To FDA, Pulls Painkiller Off Market For First Time In History

REUTERS/George Frey

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Steve Birr Vice Reporter
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A pharmaceutical company behind a popular painkiller brand linked to rising rates of abuse agreed to a request from the Food and Drug Administration to pull the pill off the market.

Endo Pharmaceuticals announced the decision Thursday following an internal review of the drug sparked by the FDA order. Officials from the FDA told the company June 8 to pull an extended release painkiller, called Opana ER, from the market and threatened to withdraw their approval for the drug if the company did not comply, the Associated Press reported Friday.

The unprecedented move came in the wake of reports patients were crushing up the pills to inject. Representatives for Endo said they stand by the safety profile of Opana ER and believe the benefits outweigh the risks. They say the pills is safe and effective when administered properly, but will comply and work with the FDA on the issue.

This marks the first time the FDA has ordered the removal of a previously approved opioid painkiller from the market due to abuse and addiction.

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 said in a statement June 8. “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 accidental death for Americans under 50. 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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