The Food and Drug Administration has taken action to remove a powerful opiate from the pharmaceutical market. Opana ER, also known as oxymorphone hydrochloride, is about twice as powerful as OxyContin, another prescription medication that is often abused by opiate addicts.
Opana ER is meant to require daily, long-term opioid treatment for severe pain and releases the powerful medication around the clock. Approved for use in 2006, Opana ER has been a controversial drug. It potential for abuse created a wave of opiate addicts who snorted it to get high. When addiction experts expressed concern about the drug’s abuse, the manufacturer issued a new version with a protective coating. The drug later gained notoriety during an HIV outbreak in Indiana in 2015, when the drug was blamed for nearly 150 new cases in a short period of time.
Research showed that when the company reformulated the medication, people ended up injecting it instead of snorting it, causing more potential for overdose and the spread of disease. The FDA made its decision on Opana based on a review of all post-market data, including this addiction research.
The historic announcement regarding Opana was made last week, by FDA Commissioner Dr. Scott Gottlieb. It is the first time the FDA has recalled the approval of an opiate drug. Commissioner Gottleib explained that Endo Pharmaceuticals must remove Opana ER from the market 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,” Gottlieb told the media at a press conference. “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.”