Wednesday, 28 June, 2017

FDA wants opioid painkiller pulled off market

FDA Asks Drug Company to Pull Painkiller in First Opana ER Credit Rich Pedroncelli AP
Arthur Frazier | 09 June, 2017, 09:37

Despite the advisory committee vote in March, Endo said that more than half the panel members "expressed their preference that Opana ER remain on the market, but with additional regulatory restrictions to mitigate the risks of misuse and abuse".

The Food and Drug Administration said Thursday it has asked Endo Pharmaceuticals to stop selling its reformulated, extended-release painkiller, Opana ER.

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 agency said it would take formal action to remove the product from market if Endo Pharmaceuticals denies the FDA's request.

This marks the first time the FDA has taken steps to remove a now marketed opioid pain medication from sale due to the public health consequences of opioid abuse.

If Opana ER sounds familiar, it's because it was the drug of choice for many addicts at the center of an HIV outbreak in IN in 2015.

"If Endo resists taking this off the market immediately, the people who are injured or killed as a result of it being on the market longer than it should, there will be a wave of product liability litigation against the company", said Sidney Wolfe, founder and senior adviser to consumer watchdog Public Citizen. "This is the first time the agency has taken steps to remove a now marketed opioid pain medication from sale due to the public health consequences of abuse".

About 2 million Americans are addicted to prescription opioids, and 91 die every day from overdosing on a painkiller or much-cheaper heroin. In 2012, Endo replaced the original formulation of Opana ER with a new formulation meant to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.

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The request was made after the FDA determined that injecting the drug, which is one way of abusing it, was linked to outbreaks of disease, including HIV and hepatitis C.

If Endo refuses to withdraw the product, the FDA could offer the company an opportunity for a hearing to make the case for why the product should not be removed. Some other states and cities have filed similar lawsuits.

"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.

Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns".

Endo's shares fell 12.2 percent to US$12.10 in extended trading.

Opana ER brought in $158 million in sales past year for Endo, a 10 percent drop from 2015 because of generic competition, according to FiercePharma, a trade site.

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