FDA Approves OxyContin for Children as Young as 11

http://www.nbcnews.com/health/health-news/fda-approves-oxycontin-children-young-11-n409621?cid=sm_fb

http://www.hightimes.com/read/oxycontin-children-fda-approved-while-cannabis-remains-illegal

From NBC news:

"The Food and Drug Administration has approved limited use of the powerful and frequently abused painkiller OxyContin for children as young as 11 years old, the agency announced Thursday.

Dr. Sharon Hertz, director of new anesthesia, analgesia and addiction products for the FDA, said studies by Purdue Pharma of Stamford, Connecticut, which manufactures the drug, "supported a new pediatric indication for OxyContin in patients 11 to 16 years old and provided prescribers with helpful information about the use of OxyContin in pediatric patients."

OxyContin is a long-release version of oxycodone, an opioid that acts on the brain like heroin and is intended for only the most severe and chronic pain cases.

Because oxycodone and other opioids are extremely powerful and highly addictive, they're very tightly regulated — and very popular with addicts and pill pushers.

Purdue reformulated OxyContin five years ago to make it harder for patients to crush the pills for a fast high.

Hertz said the FDA was putting strict limits on the use of OxyContin in children. Unlike adults, children must already have shown that they can handle the drug by tolerating a minimum dose equal to 20 milligrams of oxycodone for five consecutive days, she said.

"We are always concerned about the safety of our children, particularly when they are ill and require medications and when they are in pain," she said. "OxyContin is not intended to be the first opioid drug used in pediatric patients, but the data show that changing from another opioid drug to OxyContin is safe if done properly."

The only other time-release opioid approved for children is the Duragesic patch, which releases fentanyl."


I remember watching "The Culture High" documentary where a father was trying to wean his little boy off opiates. He called the company who made the opiates, they were like "Why is a child on this drug? We don't have resources to detox such a young patient." Not exact quote but pretty similar.

This makes me really sad to think how many young lives will be negatively impacted by this.

Un-fucking-believable.

If only there were something a little less dangerous that might work in these scenarios. Oh, wait...

My son had a terrible injury when he was a little boy 10 yrs old. He was in the hospital 3 weeks and he was on some pretty strong pain killers. This was quite a few years ago, I thought it managed his pain pretty well. I wonder if this is for tiny children that have been in a horrible accident or possibly like an organ transplant? I haven't paid much attention to it.

It's crazy though that cannabis is scrutinized so much. It is just years of brainwashing the public - Reefer Madness mentality.

Even with opiates it seems prohibition is a big part of the problem. If people were simply allowed to grow a few poppies and get cheap and effective pain relief as the creator provided for us in an easily grown plant, we wouldn't see all this criminality and expensive pharmaco bullshit. Prohibiting it doesn't eradicate addiction anyway.

Not surprised. Its all about the money.

If they want to approve of Oxycontin as so thats fine, its someone's (or parents in this situation..) responsibility to research what they are doing before they done, lying about Cannabis tho to improve sales? Not okay.

Can someone tell me why only ages 11-16..?
Are the prescriptions cancelled at age 17?
Why not offer to everyone? You would only be making more money which is the whole point of this..

Could be just luck of the draw, but where I'm at the doctors won't prescribe shit. My grandad had some much trouble getting prescribed. It took 6 different doctors. That man was fully crippled during war.. Soooo he doesn't need them, but the 11 year old with the boo boo on his leg needs them? Sure.

Please do not think i am saying there are not people out there ages 11-16 with life effecting medical problems, because i know there are, but I'm pretty sure there are more mid aged to older people that are in severe pain VS 11-16 year olds children..

A1FBG said:

Can someone tell me why only ages 11-16..?
Are the prescriptions cancelled at age 17?
Why not offer to everyone? You would only be making more money which is the whole point of this..

Click to expand...

It is already approved for those 17 and older. They were just expanding the accepted age range for prescription from what I see.

Could be just luck of the draw, but where I'm at the doctors won't prescribe shit. My grandad had some much trouble getting prescribed. It took 6 different doctors. That man was fully crippled during war.. Soooo he doesn't need them, but the 11 year old with the boo boo on his leg needs them? Sure.

Please do not think i am saying there are not people out there ages 11-16 with life effecting medical problems, because i know there are, but I'm pretty sure there are more mid aged to older people that are in severe pain VS 11-16 year olds children..

Click to expand...

I feel like you're missing the point.

There are without a doubt more middle aged/older people with severe pain then children, people aren't debating that. The fact that your grandfather couldn't get a prescription has nothing to do with this announcement or policy. That's simply a factor of the doctors in your area.

This policy just extends the age range that a prescription can be given. The two things are not related.

Roth said:

It is already approved for those 17 and older. They were just expanding the accepted age range for prescription from what I see.





I feel like you're missing the point.

There are without a doubt more middle aged/older people with severe pain then children, people aren't debating that. The fact that your grandfather couldn't get a prescription has nothing to do with this announcement or policy. That's simply a factor of the doctors in your area.

This policy just extends the age range that a prescription can be given. The two things are not related.

Click to expand...

ah, i did mis understand. thanks for the clear up

part of my whole misunderstanding was i had only remembered they discontinued the original Oxycontin, but this is a less abusive form, that is now being released for adults and children

Children are in horrific accidents or need operations all the time. They do need safe pain control and that might mean hard core drugs. This could be a good thing. Short term pain control for children is something that is sometimes needed.

Silver420Surfer said:

Dr. Sharon Hertz, director of new anesthesia, analgesia and addiction products for the FDA, said studies by Purdue Pharma of Stamford, Connecticut, which manufactures the drug, "supported a new pediatric indication for OxyContin in patients 11 to 16 years old and provided prescribers with helpful information about the use of OxyContin in pediatric patients."

Click to expand...

Am I the only one reading this as: FDA director(coughpaidoffcough) recommended approval of this based on a study provided by the...drug...manufacturer. How is this valid "proof"? Seems shady as shit...BUT, it's for the kids, so, fuck actual studies not done by the manufacturer.
If we had higher-ups at Children's Hospitals, or St. Joseph's, child/patient advocacy groups calling out for this need, it would certainly feel less like a money grab, imo.

CarolKing said:

Children are in horrific accidents or need operations all the time. They do need safe pain control and that might mean hard core drugs. This could be a good thing. Short term pain control for children is something that is sometimes needed.

Click to expand...

For sure, there are definitely times that a strong pain killer like various opioid's are needed.

My disbelief is more at the fact they can approve these hard core drugs for kids, but can't acknowledge the possibilities that cannabis can provide.

And like @Silver420Surfer , the fact that this "study" came from the very manufacturer of the drug screams corruption. I'm not saying kids might not benefit from it, I'd just rather 3rd parties being the ones that called for it.