FDA Calls On Drugmaker To Pull A Powerful Opioid Off The Market

Francis Osborne
June 9, 2017

"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", said FDA Commissioner Scott Gottlieb, M.D., in the news release.

The withdrawal marks the first time the agency taken steps to remove an opioid pain medication due to the public health implications and comes amid an intense national debate about the abuse of opioids. The pill became notorious after it was blamed for prompting an HIV outbreak in rural in in 2015, and it was also linked to reports of a rare but serious blood disease characterized by clots that can lead to organ damage. "We will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits". It reformulated that drug in 2012 and claimed the changes made it harder to manipulate physically or chemically to abuse it. Endo tried to persuade FDA officials that the new formulation was abuse-resistant, which likely would have given the product a marketing advantage in the crowded, lucrative category of opioid painkillers. "When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market", Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

As STAT has noted previously, Opana ER is meant to be swallowed and the contents released over 12 hours, which is known as extended release.

The FDA has been reviewing the drug's risks for several months.

The decision came after an FDA advisory panel voted 18-8 in March that the benefits of Opana ER no longer outweigh the risks.

About 2 million Americans are addicted to prescription opioids, and 91 die every day from overdosing on a painkiller or much-cheaper heroin.

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"When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market", Woodcock added in a statement.

The FDA says if the company fails to voluntarily withdraw the drug the agency will force Opana ER's removal from pharmacy shelves by revoking its market approval. "This action will protect the public from further potential for misuse and abuse of this product".

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.

"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak", said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

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.

Other reports by TheDailyFarc

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