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For the First Time, Legal Drug Gets Axed by Opioid Epidemic

06-12-2017

The opioid drug epidemic has become so deadly, the FDA is now having to weigh the damage a painkiller can cause against the good it can do.

It's asked the makers of OpanaER, an analgesic prescription painkiller twice as powerful as the more well-known OxyContin, to pull OpanaER off the market. The FDA announced this is the first time it has asked for the ban of a legal drug because of what it calls "the public health consequences of abuse."

OpanaER is called "Ops" or "panda" in the illegal drug world where addicts snort or inject it.

If Endo Pharmaceuticals, OpanaER's maker, doesn't voluntarily remove it from the market, the FDA will almost certainly force its removal by pulling its approval of the painkiller.

"The agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks," the FDA announced in a statement.

"We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduced the scope of opioid misuse and abuse," said FDA Commissioner Scott Gottlieb, M.D.  

The FDA commissioner has come under fire in recent months for not doing more about this crisis.

"We've reached a tipping point in the opioid epidemic gripping the nation in which the impact on public health must now be weighed whenever a new painkiller is introduced into the market," said Dr. Damon Raskin, an addiction medicine specialist at Los Angeles' Cliffside Malibu addiction treatment center.

The CDC estimates the drug epidemic is costing the lives of some 91 Americans daily.  

Drug overdoses kill more Americans under 50 years old than any other cause. And they appear to be a major reason the death rate for Americans aged 25 to 44 is rising after decades of declines.

Between 2010 and 2015, CDC statistics show the death rate in that age group has gone up 18% for Native Americans, 12% for whites, 7% for Hispanics and 4% for African Americans.

"The opioid epidemic impacts communities of every size throughout the country and is affecting all age, ethnic and economic groups," Dr. Raskin stated. "The FDA ban of OpanaEr is a step in the right direction."  He added, "There continues to be a place for prescription painkillers in the treatment of patients suffering from chronic pain, but there are alternatives to drugs that are highly addictive and can be easily abused."

 

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