FDA asks drugmaker to stop selling its opioid painkiller

Besides contributing to overdoses, abuse of Opana ER was blamed for a 2015 outbreak of HIV and hepatitis C in southern in linked to sharing needles, according to the FDA.

The company must now choose between voluntarily taking Opana off the market or face an impending formal FDA drug approval withdrawal. "We will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits".

Responding to the FDA request, Endo said it is reviewing the request and is evaluating the full range of potential options as it determine the appropriate path forward.

Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The FDA's reasoning was simple: the risks of the medication Opana ER outweigh the benefits, the agency said Thursday in a statement. Injections of the drug by people with an addiction disorder have continued to trigger outbreaks of HIV, which causes the acquired immune deficiency disorder (AIDS), and hepatitis C, potentially fatal liver infection, as well some cases of the serious blood disorder known as thrombotic microangiopathy. If the company does not choose to do so voluntary, the FDA will force the issue by withdrawing its approval for the drug.

"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. Scott Gottlieb, the FDA's commissioner, in announcing the move.

FDA requests removal of Opana ER for risks related to abuse [news release]. "When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market".

The agency has been criticized in the past for examining the safety and effectiveness of individual opioid painkillers without considering the wider impact each could have on the nation's epidemic.

An FDA review of available data on the drug found that the way people abuse the medication had shifted significantly after its reformulation, changing from snorting to injection.

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.

Opioids were involved in more than 33,000 deaths in 2015 and opioid overdoses have quadrupled since 1999, according to the Centers for Disease Control and Prevention. "This action will protect the public from further potential for misuse and abuse of this product".

The FDA says it has approved 10 opioid medications as abuse-deterrent, including Pfizer Inc.'s Troxyca and Purdue Pharma LP's OxyContin.

Randall Stanicky, an analyst at RBC Capital Markets, said Opana ER is a declining asset whose sales are expected to fall to US$97 million in 2019, down from an estimated US$134 million in 2017.

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