FDA requests removal of opioid from Endo Pharmaceuticals

FDA requests removal of opioid from Endo Pharmaceuticals

FDA requests removal of opioid from Endo Pharmaceuticals

According to the FDA, there are no generic versions of the reformulated Opana ER on the market.

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.

But new FDA commissioner Scott Gottlieb last month said his immediate priority is to target opioid abuse and he has established a commission to come up with new ways of dealing with the crisis. Spokeswoman Sarah Peddicord said, "The FDA's work to assess the benefit-risk framework for all opioid medications is part of a broader administration-wide strategy to combat opioid abuse".

The FDA said in its statement that if Endo does not meet its request, it will take steps to withdraw approval of the drug, prescribed when someone needs a long-term pain medication.

This is the first time that the federal agency has requested that a drug company voluntarily stop selling a medication because of the risk of abuse that the drug carries, the FDA said in a statement.

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The FDA said data obtained post-marketing showed that more people were finding ways to inject the drug contained in the pill despite a 2012 reformulation created to prevent that type of abuse.

"All opioids have the potential to be abused if someone has risk factors for misuse of opioids", said Paice, Ph.D., R.N., who also is a research professor of medicine at Northwestern University Feinberg School of Medicine.

In the meantime, the FDA is focusing its efforts on educating health care professionals about this request to remove Opana ER from the market. "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". A review from 2015 of drugs pulled from the market found that between 1996 and 2005, there were 66 withdrawals, of which just two were for reasons of safety or effectiveness.

The drug was reformulated in 2012 in an attempt to make the medication more hard for people to abuse; specifically, the drug makers sought to make it hard for users to snort or inject the drug.

The centers for disease control says the United States is suffering an epidemic of opioid overdoses.

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The FDA approved it for this use in 2006.

In 2013, the Centers for Disease Control and Prevention (CDC) reported 15 cases in Tennessee of thrombotic thrombocytopenic purpura (TTP)-like illness associated with intravenous Opana ER abuse.

Still, according to the minutes of the March meeting, committee members were under no illusion that removing Opana ER from the market would solve the problem of painkiller abuse.

Maryland declared opioid abuse a state of emergency this year.

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