FDA Asks Drug Company to Pull Painkiller in First

The following Schedule 2 narcotics are shown: Morphine Sulfate Oxy Contin and Opana

The following Schedule 2 narcotics are shown: Morphine Sulfate Oxy Contin and Opana

Last week, the FDA asked Endo Pharmaceuticals to withdraw its Opana ER from the market because of signs that abusers were injecting the painkiller.

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

Scott Gottlieb, the FDA Commissioner, said that they are facing an opioid epidemic - a public health crisis and they must take all necessary steps to lessen the scope of opioid misuse and abuse. The agency is trying to contain an outbreak of unsafe infections by addicts who abuse drugs like Opana ER that are approved for legitimate pain relief.

The drug company states that it's reviewing the request and will determine its path forward. The company also said that "despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed".

Endo first got USA approval for its extended-release opioid, Opana ER, in 2006. The agency has asked Endo Pharmaceuticals to voluntarily pull the drug.

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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.

In 2012, Endo Pharmaceuticals reformulated the drug to make it more hard to snort but the FDA found that move led to more injections and a rise in both HIV and Hepatitis C infections among those abusing Opana.

"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.

But before you think that as a healthy, active woman, that this issue doesn't really affect you, you should know that women are more likely to become addicted to painkillers, which can often lead to illicit opioid drugs such as heroin.

In the meantime, the FDA is focusing its efforts on educating health care professionals about this request to remove Opana ER from the market.

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Endo has had other issues with the FDA and the drug.

The Centers for Disease Control and Prevention says opioid overdoses have hit record highs, killing more than 40,000 people in 2015 - more than the 32,000 who died in road accidents.

Dr. Neil Shusterman, chief medical officer of Endo, told a CDC committee in March that 75 percent of all Opana abuse reports compiled by the federal government after the drug was reformulated originated in Tennesse.

Dr. Gottlieb says the FDA needs better scientific information to understand how to optimize its assessment of abuse-deterrent formulations. The group of experts voted 18-8 that the long-acting painkiller was doing more harm than good.

It is a small step in fighting the rising tide of opioid abuse.

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