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http://www.cnn.com/2017/06/08/health/fda-opioid-opana-er-bn/index.html
(CNN)The US Food and Drug Administration said Thursday that drugmaker Endo Pharmaceuticals must remove its powerful opioid painkiller Opana ER from the market. The agency says this the first time it has asked that an opioid pain medication be pulled due to "the public health consequences of abuse."
"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. "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 drug is about twice as powerful as OxyContin, another often abused opioid. Opana ER, oxymorphone hydrochloride, is used to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternatives aren't strong enough, according to the manufacturer's website. The FDA approved it for this use in 2006.
"My comment is 'wow,' " said Dr. Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University. "This is pretty exciting. This is big news."
Though it is a "good sign" for the fight against opioid abuse, he said, "Opana is not the only one that needs to come off the market."
Endo had tried to make it harder for addicts to use Opana ER by making it with a coating that made it hard to crush. The medication is intended to release over time, but addicts had been crushing it to get a massive high all at once.
(CNN)The US Food and Drug Administration said Thursday that drugmaker Endo Pharmaceuticals must remove its powerful opioid painkiller Opana ER from the market. The agency says this the first time it has asked that an opioid pain medication be pulled due to "the public health consequences of abuse."
"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. "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 drug is about twice as powerful as OxyContin, another often abused opioid. Opana ER, oxymorphone hydrochloride, is used to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternatives aren't strong enough, according to the manufacturer's website. The FDA approved it for this use in 2006.
"My comment is 'wow,' " said Dr. Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University. "This is pretty exciting. This is big news."
Though it is a "good sign" for the fight against opioid abuse, he said, "Opana is not the only one that needs to come off the market."
Endo had tried to make it harder for addicts to use Opana ER by making it with a coating that made it hard to crush. The medication is intended to release over time, but addicts had been crushing it to get a massive high all at once.