New drug approved

[Merri123]

I was reading an article yesterday. New pain killer has been approved  

Zohydro

It is a large dose of hydrocodone. They say it is dangerous bc of the high dose. Supposedly only for those who have severe pain and nothing else works. They say it can kill you easily bc no one understands how high amount is in one pill.

Scary. Wanted to warn us all. Doctors are fighting to have it taken off market. Please make sure your loved ones do not take this.  

[motye51]

My thought would have to be this...if chronic pain people are taking their meds the.way their supposed to, then the acetomeniphin shouldn't be a worry? If your taking it LIKE YOUR SUPPOSED TO??? Not trying to take.away from REAL pain patients, but I think the numbers are ********!

[onthefence]

nothing is tamper proof, maybe tamper resistant , unfortunately, op's, Purdue's
reformulation of Oxycodone HCI controlled release pills are not that difficult to abuse, and have been a problem for alot of legitimate pain patients.
Purdue did get another 8 year patent out of it though......

[clean_in_ks]

"Somebody" decided (and reported) that this topic on a new potent narcotic drug was meant for the "social" community of substance abusers which is TOTALLY NUTS to me!!
If anybody needs to know about what new narcotics are out there waiting to be abused because they have no "abuse deterrent" in them.....drug addicts...recovering or not....surely do!

If you read the link given by KBusymom in the original post I referenced...and then take the time to read the WHOLE article about zohydro (which VERY FEW people will even do)....you will see that the "other Extended Release" pain med (Oxycontin) was forced to "add" an abuse deterrent to their product which MAJORLY cut down on abuse and street sales.  Now we have a NEW drug 10x stronger than hydrocodone....and the ADVISORY COMMITTEE,  by a HUGE MAJORITY... voted AGAINST it's approval......at least until an abuse deterrent is forumulated into the drug.  ALL the advise given by the committee came from their RESEARCH into abuse and addiction/death potential.  What is safe before we approve this monster drug??
Not to repeat myself....but look at the statistics here:

"Zohydro is about 10 times stronger than hydrocodone.  It has no acetaminophen in it at all..it also does NOT have an "abuse deterrent" in it.

The abuse of OxyContin was dramatically improved when Big Pharma was forced to add an abuse deterrent to the chemical makeup of the drug.  PROVING that formulating a tamper-proof form of OxyContin cut down on it's horrific abuse.

Zohydro and OxyContin are both designed as ER (extended release) only to be taken every 8-12 hrs.

If children take this new Zohydro....it could be toxic and kill them.  

Here's what happened.....there was an advisory panel appointed to review ALL aspects of approving Zohydro.  This advisory panel's recommendation to the FDA was completely ignored.  There was a LANDSLIDE vote by the FDA...11-2 with 1 abstention vote to APPROVE this new drug Zohydro!!!!!!  The FDA went AGAINST what the advisory panel's findings were.

Big Pharma and powerful lobbyists and $$$$$ have won out over true concern for the people of our nation.

The FDA said "we could not NOT approve Zohydro" ???????
What could the FDA possibly mean that they "could not NOT approve Zohydro or delay approval until a tamper-proof form was developed." ????

Some hogwash justification was attempted by saying acetaminophen in hydrocodone causes liver toxicity and this new drug was acetaminophen-free.  Doesn't matter that it is 10X STRONGER!!!!
Also....get this, "while liver toxicity from acetaminophen is indeed a problem, fewer than 250 Americans die annually from it due to aceta-opioid combinations.  Meanwhile, more than 16,000 died in 2011 of prescription opioid overdoses with the numbers climbing."

250 Americans die from actaminophen toxicity versus 16,000 from opioid overdoses?????????
What about all the teens and young people getting their hands on this stuff???  
I'm ALL FOR CHRONIC PAIN help.....I "AM" a chronic pain patient!!!!!!

When you appoint a committee to research and evaluate and advise.....and then vote AGAINST what your committee RECOMMENDS????  And you say we couldn't NOT approve this?  Ignoring safety of an abuse deterrent?

I see a lot of danger ahead.......waiting until an abuse deterrent was added was IGNORED.......more addicts will seek out this powerful drug....more will snort it....shoot it.....because it DOESN'T have a deterrent in it.  More addicts will die......it breaks my heart.  And the FDA is ignorant imo...with only their pocket books doing the voting....not the safety of the American people~
Am I passionate about this?  Hell yeah~

[jugglin]

You are right Merri..guard up. Zohydro ER was approved by the FDA in the fall and is expected to launch this March...(extended release). I know I was really wordy, but am passionate about chronic pain management.  I agree that is important for us to be aware that it is out there...when we see or hear the name, we addicts know exactly what is in front of us.  Thank you for the reminder!

[Merri123]

I totally understand what you are saying. I too know many who legitimately have medical conditions that cause constant pain. No one should have to live in pain all the time.

I must have misread bc I thought Zohydro was not extended release. I thought it was for those that extended release does not work for.

I guess what scares me is how powerful it is and how you can OD off it so easily. Especially teens.

With any medicine - we must all be aware and careful for ourselves and those we love.

[jugglin]

I may get slammed for this post, but just want to state my opinion. I have watched loved ones suffer in pain. This new drug is extended release and designed for those with unmanageable pain w/o the acetaminophen which can cause liver damage.  Do we need another pain med on the market? I'm not to say.  The idea of extended release is to better manage the pain and reduce addiction.  If this med truly helps others in severe pain with less damage to organs, then I would want to see it used when appropriate. It is a schedule II drug and designed to be heavily monitored.  As an addict, I do not blame big pharma or my Dr for my addiction, my choices.  Had my Dr ever even over-prescribed (which he did not)....I take full responsibility for my addiction. I work in a related field and know that big pharma is looking to make a buck but are also genuinely wanting to ease the lives of chronic pain patients. I see it firsthand every day. Sorry...I hope this didn't come across like a rant, really just my opinion.

[motye51]

Yeah, well oxy's were only supposed to be for severe pain...and look how that turned out!  LOL...legal drug dealers, that's it. The gov't wants its tax dollars and we're stupid enough to do it! ( At least I did )...

[Merri123]

Wow. Guess you all beat me to it. I had not heard about it till now.

Thank you for the link!!

[clean_in_ks]

http://www.medhelp.org/posts/Addiction-Social/Has-anyone-heard-of-zohydro/show/2063395