War on Opioids: FDA wants Opana ER yanked

Opana ER label

The War on Opioids began last week, when the U.S Food and Drug Administration (FDA) called on Endo Pharmaceuticals to remove its Opana ER from the market. The extended release pain reliever has become popular with drug abusers and has been linked to several outbreaks of HIV and hepatitis C, the FDA said.

“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”

Endo reformulated the drug to cut down on the number of abuse cases, but FDA officials say that consumers are simply changing the way they abuse the drug and an FDA advisory committee found in March 2017 that the changes did not outweigh the drug’s potential for misuse and abuse.

The FDA said that further reformulation of the drug would not “meaningfully reduce abuse” and declined Endo’s request for a warning label advising consumers of the potential risk.

The FDA’s request to Endo has no immediate legal consequence. The drug is still FDA-approved but if the company does not withdraw it voluntarily, or find some way to convince the FDA to change its mind, the agency is expected to take further action to cancel Opana’s approved status, most likely through a finding that the drug’s benefits do not outweigh the risks associated with it.

FDA Commissioner Scott Gottlieb said that the agency will look at other opioid medications as well, to determine if the benefits outweigh the risks.

“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,” he 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.”

 

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Truman Lewis
Truman has been a bureau chief and correspondent in D.C., Los Angeles, Phoenix and elsewhere, reporting for radio, television, print and news services, for more than 30 years.