oxycodone approved for kids??

[Jrapp]

so the FDA approved oxycontin for use in kids as young as 11 (see USAToday 8/14/15) and based its decision on studies done by the maker of the drug after it asked Purdue Pharma to do the studies?!! this is absolutely insane and is the epitome of regulatory capture in this country. I honestly don't know how anyone can take the crap that comes out of the FDA seriously when many of those paper-pushing commisars are directly or indirectly linked to the industry they allegedly regulate. I can understand the use of powerful opiates in a pediatric oncology patient and will ask my neighbor about it as he is a pediatric oncologist but this is just plain mad to approve it for the general pediatric population???? Hello?? Ever since moving to this country I have seen just how badly addicted and sleep deprived Americans truly are and its downright scary. And now they want to legally introduce a powerful drug such as Oxy to the pediatric population??? Oxy has a terrible legacy of addiction. In Canada where I'm from and practiced as a pharmacist for several years we approached the approval of new drugs or new indications for old drugs with caution and suspicion - better yet we used post-phase 3 data from the American population before making any approvals. Funny, I remember the stupid drug reps in Canada when they phased out OxyContin for a new product called OxyNeo that was harder to abuse because when junkies tried to snort or inject it it became all gooey - but then one day I was working at a methadone clinic pharmacy and one of the junkies coming in for his drink said "eh its not a problem we can get around that just freeze the tablets and smash'em with a hammer - problem solved!"

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[BidingMyTime]

It really doesn't matter, once a drug is approved by the FDA, it can legally be used off-label for anything and given to anyone. In other words, oxycodone already was legally being given to children, even children younger than 11, way before this decision. All the FDA decision does, is make it legal for drug companies to advertise and promote oxycodone for children (which really isn't necessary, since as you point out, oxycodone already is being heavily used.)

 

[Jrapp]

wow really? i've been working here for only a few years and I haven't come across any such prescriptions in community retail but i'm sure there are those in hospital who may have seen it. thanks for clearing that up yea i believe you are right this just now gives the company and certain unscrupulous doctors legal cover - disgusting.

 

[Lnsean]

wtf are you talking about...they prescribe oxy solution all the time for post-op in children.

 

[awval999]

they've used oxycodone for years in pediatric patients. this is not news.

 

[Jrapp]

wtf are you talking about...they prescribe oxy solution all the time for post-op in children.

Obviously you did not read my post - i wasn't aware of it heavy use in peds having never worked in hospital. What I'm more concerned with is the legal ramifications of the fact that it is now legally indicated for ALL kids in that age group. Off label prescribing is rampant enough in this country as it is - you obviously have no problem with seeing young kids get hooked at an early age as this was a serious concern mentioned by all stakeholders in this decision.

 

[Lnsean]

Obviously you did not read my post - i wasn't aware of it heavy use in peds having never worked in hospital. What I'm more concerned with is the legal ramifications of the fact that it is now legally indicated for ALL kids in that age group. Off label prescribing is rampant enough in this country as it is - you obviously have no problem with seeing young kids get hooked at an early age as this was a serious concern mentioned by all stakeholders in this decision.

Not to be petty, but I would love to read the sources for these "serious concerns" that they have. If you could link that for me, I'd be better informed.

Of course, there will always be room for concern with any type of drug. You should know this. Obviously, the FDA feels that the benefits outweighs the risks and that line is for clinicians to evaluate and to draw. Oxy has been used for years in pediatric population: there is an established standard of care.

 

[BidingMyTime]

What I'm more concerned with is the legal ramifications of the fact that it is now legally indicated for ALL kids in that age group.

What are you talking about? Of course, oxycodone is NOT legally indicated for "all kids" in that age group. No one is putting it in drinking water (like fluoride.) You are acting like doctors are suddenly going to start giving out oxycodone prescription to children on their well-child visits....gimme a break, this isn't going to happen. Oxycodone will still continue to be used for children with serious pain, when the oxycodone is likely to be the safest and/or most effective pain relief for that child's particular situation. If *you* want to suffer in pain, go for it. But most people don't want to see children suffering pain, nor do the children want to suffer pain. Of course, there are risks with oxycodone, there are risks with ALL drugs, including acetaminophen. The vast majority of children who use oxycodone do NOT become addicted to it (just as most adults who use it do NOT become addicted to it.)

 

[Corpseman]

What are you talking about? Of course, oxycodone is NOT legally indicated for "all kids" in that age group. No one is putting it in drinking water (like fluoride.) You are acting like doctors are suddenly going to start giving out oxycodone prescription to children on their well-child visits....gimme a break, this isn't going to happen. Oxycodone will still continue to be used for children with serious pain, when the oxycodone is likely to be the safest and/or most effective pain relief for that child's particular situation. If *you* want to suffer in pain, go for it. But most people don't want to see children suffering pain, nor do the children want to suffer pain. Of course, there are risks with oxycodone, there are risks with ALL drugs, including acetaminophen. The vast majority of children who use oxycodone do NOT become addicted to it (just as most adults who use it do NOT become addicted to it.)

Just let the kids abuse it responsibly.

 

[owlegrad]

I am a little confused. Aren't studies for testing safety and efficacy for children encouraged? Would you rather not treat severe pain in children? Or would you just prefer it stay off label and unstudied?

 

[Lnsean]

I am a little confused. Aren't studies for testing safety and efficacy for children encouraged? Would you rather not treat severe pain in children? Or would you just prefer it stay off label and unstudied?

You're trying to preach to people who have an already preconceived bias towards anything that is classified as a narcotic. These are the same pharmacists who will turn away a patient just because he/she dresses a certain way or looks of a certain demographic.

 

[owlegrad]

I think OP wrote this: http://www.gomerblog.com/2015/08/fda-approves-oxycontin-for-kids/

 

[zelman]

I think OP wrote this: http://www.gomerblog.com/2015/08/fda-approves-oxycontin-for-kids/

I feel stupider for having read that garbage.

 

[owlegrad]

I feel stupider for having read that garbage.

Ah come on, it's just satire. I didn't enjoy this article as much as I usually do though.

 

[zelman]

Ah come on, it's just satire. I didn't enjoy this article as much as I usually do though.

This whole paragraph is poorly worded nonsense:

The FDA used its studies to show that taking OxyContin is very similar to riding a rollercoaster. Children’s response to the ride is an excellent predictor of how well-tolerated OxyContin will be at any tender age. The FDA considered dosing the wee ones according to rollercoaster height, but decided on a singular rollercoaster as a gauge. “The same rules still apply,” said the FDA, “You still must be accompanied by an adult.”