![]() Shots - Health News Dangers Of Opana Opioid Painkiller Outweigh Benefits, FDA Panel Says "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," Gottlieb says. Scott Gottlieb, the FDA's commissioner, in announcing the move. "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," says Dr. The sharing of needles by these drug users has fueled an outbreak of associated infectious diseases - HIV, hepatitis C and another serious blood disorder. The FDA says the move marks the first time the agency has taken steps to remove an opioid from the market because of "public health consequences of abuse."Īn increasing number of people, the FDA says, are abusing the powerful prescription pills by crushing, dissolving and injecting them. The Food and Drug Administration requested Thursday that the drugmaker Endo Pharmaceuticals stop selling Opana ER - its extended-release version of Opana. But the agency says Endo's attempts to reformulate the pills to make them harder to crush, dissolve and inject have not been successful. ![]() ![]() Opana ER, a potent extended-release opioid, was approved by the FDA for pain management in 2006. ![]()
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