Published: Fri, June 16, 2017
Medicine | By Earnest Bishop

Manchin applauds FDA decision toremove opioid pain meds from market

Manchin applauds FDA decision toremove opioid pain meds from market

"This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks".

In fact, it marks the first time that the regulator has taken initiative to ban a now marketed opioid pain medication from sale because of consequences of abuse to public health.

The Endo Pharmaceuticals drug is an example of an abuse-deterrent effort that was ineffective. It's not a gentle request. "Opana ER is prescribed for patients who have severe pain", he says.

Endo International released a statement in response to the FDA's announcement saying it is "reviewing the request and evaluating the full range of potential options as we determine the appropriate path forward".

The FDA is asking an Irish pharmaceutical company to take one of its pain medications off the market because of its contributions to America's opioid epidemic, USA Today reports. It reformulated that drug in 2012 and claimed the changes made it harder to manipulate physically or chemically to abuse it. While removing Opana from the market is a step in the right direction, there is more work to be done to prevent opioid addiction and to ensure every family impacted by the opioid epidemic has access to quality treatment facilities.

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Flannery's experience includes work at GE Capital, evaluating risks for leveraged buy-outs, and leading restructuring efforts. The new CEO may be more willing to pursue a much-needed breakup of the company, Davis said.

But FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company's request to include labeling describing potentially abuse-deterrent properties for Opana ER.

The FDA said it made its latest decision based on a review of all post-market data, which suggested that when the company reformulated the medication, people were injecting it more than they were snorting it. Both viruses spread when people share needles. The epidemic that began two decades ago with legally produced and distributed prescription drugs has given way to an out-of-control surge in illegal sales and use of fentanyl, a drug considered many times more potent than heroin, much of it originating in China, which accounted for more than half of the deaths recorded past year in Maryland.

More important, wrote William Becker and David Fiellin, the issue shouldn't distract physicians from pursuing alternatives to treat pain, such as cognitive therapy and yoga. If the FDA withdraws its approval after the hearing, Endo could sue. Everett, Washington sued Purdue Pharma, the maker of the opioid Oxycontin. There have also been cases of a serious blood disorder called thrombotic microangiogpathy linked to the abuse of the drug.

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

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