28 states ask FDA to rethink approval of new painkiller drug Zohydro

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28 states ask FDA to rethink approval of new painkiller drug Zohydro

A group of state attorneys general expressed concern to the U.S. Food and Drug Administration that the narcotic painkiller Zohydro - said to be five to 10 times stronger than drugs like Vicodin - will only contribute to the national epidemic of prescription drug abuse.

Though an FDA advisory panel recommended against approving Zohydro, the agency approved it in October - sparking concern that the potent new prescription painkiller will be too easily abused.​


"More than two dozen state prosecutors are asking the Food and Drug Administration to reconsider its approval of a powerful new painkiller called Zohydro, saying that the narcotic pill could add to the national epidemic of prescription drug abuse.
The FDA approved Zohydro in October, making it the first single-ingredient hydrocodone drug ever cleared for U.S. patients. The pill uses an extended release formulation that is reportedly five to 10 times more potent than currently available hydrocodone combination pills, such as Vicodin. The approval surprised many doctors, since an FDA advisory panel previously voted overwhelmingly against the drug, citing its potential for abuse."

http://www.nydailynews.com/life-sty...ink-approval-new-painkiller-article-1.1545864
 
With all the drama surrounding this drug, I expect that it will not be prescribed as often as Oxycontin was once prescribed. If it's prescribed at all. Maybe no doctor will prescribe it.
 
Wonder how the time release on these pills will turn out.

Personally I see this as a big step forward, no more hand fulls of vicodens for pain patients.
Also can't wait for the day when Tylenol and drugs like it are removed from opiate pain meds. Which apprently is on the horizon.
 
I don't understand why they took the FDA's advise of "no APAP" and decided to go ER with hydrocodone. Why not make Hydro IR? (hydrocodone in 5, 10, 15mg tablets) Even compete with Roxicodone and make 30mg? I guess there's no money in that... But why no generic even?

I don't really see a problem with it honestly. Lots of people take hydrocodone honestly, and they don't want (or need) anything stronger (possibly due to stigma but maybe just not as serious pain). There are real objective problems with taking lots of Vicodin every day, so why not give these people an alternative to take only 1 or 2 pills/day? Yes it's money for Big Pharma clear and simple, but it's a drug that clearly has a market, and I'm surprised hasn't been formulated before.
 
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