FDA asks drugmaker to stop selling its opioid painkiller

FDA asks drugmaker to stop selling its opioid painkiller

Donnelly said, "This is welcome news, and I am pleased by the FDA's action".

Opana ER (oxymorphone hydrochloride) was first approved by the FDA in 2006 for use by people with moderate or severe chronic pain. Increased needle-sharing of the drug has since been linked to serious blood disorder cases in Tennessee in 2012 and a 2015 outbreak of HIV and hepatitis C in IN, officials said.

The agency said that the decision came after it found that the drug's benefits no longer outweighed its risk for abuse. As opioid abuse continues to take a heavy toll on communities in IN and across the country, we must take steps to confront this public health epidemic.

The drug was reformulated in 2012 in an attempt to make the medication more hard for people to abuse; specifically, the drug makers sought to make it hard for users to snort or inject the drug.

When reached for comment by Consumerist about the FDA's request, Endo would not say whether it will oblige the FDA and remove Opana ER.

In a statement, the company said it was reviewing the FDA's request but that it "remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients".

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Matthew Herper at Forbes noted that Oxycontin was removed from the market when an abuse-resistant form became available, but the difference was that Purdue Pharma initiated that - the action wasn't at the FDA's request. The FDA says if Endo doesn't voluntarily pull the drug from the market, it will withdraw approval.

This marks the first time that the FDA is seeking to remove an opioid pain medication from the market due to the public health consequences of abuse, according to the agency's announcement. If the company does not choose to do so voluntary, the FDA will force the issue by withdrawing its approval for the drug.

"When we determined that the product had unsafe and unintended consequences, we made a decision to request its withdrawal from the market", Woodcock said. 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.

From 2000 to 2015, almost 180,000 Americans died from overdoses of prescription opioids, and tens of thousands more have succumbed to heroin and fentanyl overdoses as the crisis has evolved.

Drug overdose deaths have been on the rise in the U.S., with opioid overdoses accounting for more than 33,000 deaths in 2015, according to the U.S. Centers for Disease Control and Prevention.

The company, attempting to fight drug abuse, claimed to have reformulated the drug so that it could not be crushed or molded for snorting or injection. 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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