Why everyone is afraid of new painkiller Zohydro

A health group says 1 dose of the highly addictive narcotic could kill a child. So why did officials approve it?

By InvestorPlace Feb 28, 2014 3:52PM

Image: Pills (© Sean Justice/Corbis)By William White

Zohydro, a new prescription painkiller being made by Zogenix (ZGNX) and Alkermes (ALKS), has a lot of people on edge.

Zohydro is a highly addictive narcotic that is set to release in March, and it's the first single-ingredient hydrocodone drug to ever receive Food and Drug Administration approval. (Normally, drugs that contain hydrocodone also contain acetaminophen.)

Zohydro's FDA approval was even more surprising considering that an advisory panel voted 11-to-2 against the drug before the main FDA vote.

Zohydro essentially is a higher-hydrocodone-dose version of Vicodin, itself an addictive and powerful drug. One public health group claims Zohydro is "so powerful that a single dose could kill a child," reports Examiner.com.

"You can crush it and then you can snort it, dissolve it and inject it, or swallow crushed powder and then it’s no longer slow release, long-acting form and you get a quick high from that," Dr. Michael Carome, Director of Public Citizen's Health Research Group, told NBC News.

"For someone who is not used to taking opioids, it could be fatal."

ALKS shares were down nearly 7 percent Friday, while ZGNX was down 4 percent.

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Tags: ALKS
Feb 28, 2014 5:43PM
Let me get this straight, the FDA will allow this potentialy fatal highly, addictive painkiller , but has an issue with Medical Marijuana ?!?!
WTF is wrong with this country anymore.

Feb 28, 2014 4:39PM
So, let's see who in the FDA is driving a new, expensive car this week or purchased a new vacation home on the back of the health of Americans...no biggie
Feb 28, 2014 4:33PM
maybe the government just wants everyone loaded...easier to take over that way.
Feb 28, 2014 5:33PM
 please refresh my memory, why is Maryjane illegal again ....????
Feb 28, 2014 5:23PM



Feb 28, 2014 6:51PM
So I've seen like 3 people in here posting that really understand just how stupid this scare is. The "health group" claiming that one dose could kill a child should be ashamed because hellooooo this drug is no stronger than what's been out there & available for years already. What's different about it is one thing & one thing only! There is no acetaminophen in it. Period. ACTUALLY it's nothing more than "the same" drug out there now and that has been for years minus a drug that has been shown to cause liver & stomach problems with prolonged use such as in a chronic pain management situation. So they've removed that. Big deal. The only thing that will be done by keeping this new drug off the market is to take away one less "tool" a Dr has in his bag to HELP someone suffering from pain and a child "may die from a single dose" of what's already been out there for years anyway. What a bunch of scare tactic stupidity! Keep this new drug off the market and the child "may" just eat the oxycodone or oxycontin or morphine or whatever else will be there anyway. Nothing will change because these drugs help people. This is something that should have been done a long time ago.
Feb 28, 2014 6:14PM
Jesus Christ people, get a life! Hydrocodone is a great mid level pain killer that really helps thousands of people on a daily basis. The problem is the acetaminophen can cause many more problems than the narcotic itself. Also many people are allergic to acetaminophen. The approval is a long time overdue. Besides the pain pill junkies seem are looking for the schedule 2's like Oxycontin etc....
Feb 28, 2014 4:28PM
Sounds like Dallas Buyers Club and someone paid off the FDA.
Feb 28, 2014 6:05PM
So it is your task to scare everyone with only half the facts? What a butthead you are! Great reporting for a first grader ****
Feb 28, 2014 6:11PM
Two drugs in pill form would eliminate the use of interferon injection in the treatment of hepatitis C without the severe symptoms associated wih interferon, but, the FDA will not approve of the two used together even though it has a record of killing the virus by 94%. Wonder how much the manufacturers of interferon are paying off the officials at the FDA to keep these drugs from being approved?
Feb 28, 2014 6:10PM
I have actually had some experience with these painkillers--one not so good when my Mom was prescribed oxycontin for back pain (in her 90's and living in an independent living apartment).  She followed the MD's instructions for use (1 tab every 4 hours)--after two weeks she was hooked and experiencing much dizziness, dopiness and anxiety (the latter possibly because of the dizziness and other side effects).  I got her to reduce the oxycontin to 2 bid, then 1 and then off it altogether.  She was 93 years old and weighed 100 lbs (normal weight, not drug induced).  The MD did not know what he was doing when he prescribed the higher frequency dosing for a very small, elderly woman.

OTOH, I occasionally use hydrocodone/acetaminaphen combo for lower back pain and cervical pain due to breakthrough DJD in my spine.  No problemo, exceptl I do not like to be taking ANY Tylenol due to potential kidney problems.  Thus, a hydroC only product, if carefully used could be very helpful at times--and should be cheap.  There are NO children present EVER in my home, but theft is always a concern.  If thieves should ever get their hands on the stuff and OD and die, good.

Feb 28, 2014 6:40PM
No surprise here. This is the same FDA that thinks mercury in dental fillings is OK. But the EPA's website says to open all the windows in your house and get out immediately if you break a fluorescent light bulb that contains 1/30th. as much mercury as the average filling.
Feb 28, 2014 5:18PM
I don't understand the fears. It's a stronger version of a drug that's already available. So you have to take less... so what?
Feb 28, 2014 4:36PM
it is not any different than oxycodone and oxycontin
Feb 28, 2014 6:49PM

FDA passes dangerous drugs constantly that were proven thru clinical trials to have killed a big chunk of the patients they tested it on (this is documented many times over). They get a payout from the drug company then when it kills a bunch more pple they pretend to be a surprised and that's when you start seeing the ads "Have you or someone you know taken the drug risperdol and experienced...." *Fill in the blank. ;)

The best medicne is prevention, if a natural remedy doesn't work i will take a drug as a last resort in a life or death senario. F*ck the FDA...

Feb 28, 2014 6:21PM
Overdosing = natural solution to faulty genes in the population.
Feb 28, 2014 5:34PM
WOW one dose could kill a child....nice work FDA...hey Feds make sure you keep the evil weed illegal though...and you know there kickbacks coming down the chain for this one!!! Complete ignorance at the wheel here!!!
Feb 28, 2014 4:50PM
If these two companies are set to sell a new, profitable product;  why did their shares go down?  Probably anticipating horrible repercussions.  I'm a supporter of government most of the time but now it seems that the FDA, like consumers union, is cooperative with the highest bidder.
Feb 28, 2014 5:52PM
Again, it's all about the money!  It's nice that Dr.Carome tells people exactly how to ingest the drug...Not!
Feb 28, 2014 5:23PM
Just think, if alcohol was a brand new drug in a pill form, does anyone out there think that the FDA would approve it for sale?  Vicodin was what NFL QB Brett Favre had to quit using. 
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