FDA approves use of opioid painkiller in 11-16 year olds

[PriestTheyCalledHim]

FDA approves use of opioid painkiller in 11-16 year olds

(Reuters) - The U.S. Food and Drug Administration has approved the use of opioid painkiller OxyContin in patients aged 11 to 16 who have not benefited enough from alternatives.

The long-acting drug is already used to treat adults suffering from around-the-clock pain and has been reformulated over the years to combat rising prescription drug abuse in the United States.

Unlike for adults, doctors are to prescribe the medicine only for children who can already tolerate a minimum dose of 20 milligrams of oxycodone, the active drug ingredient in OxyContin, the agency said, but retained the same set of warnings and precautions.

As few pain treatments come with pediatric safety and effectiveness information, doctors are forced to rely on their own experience to interpret adult data into dosing information for children.

The U.S. regulator has been stepping up efforts to procure more data on drugs for children by incentivising data collection.

Accordingly, the FDA had asked Purdue Pharma LP, which makes OxyContin, to evaluate the use of the drug in children.

The company said is in talks with the FDA regarding securing an additional 6 months of exclusivity for the drug, which goes off patent in 2030.

OxyContin accounted for about 2 percent of the 215 million prescriptions written for opioids last year, according to IMS Health.

About 39,000 prescriptions for extend-release opioids are written for patients aged 10-19 annually in the United States, Purdue said.

The original formulation of OxyContin, first approved nearly two decades ago, was withdrawn due to its potential for abuse.

The only other long-acting opioid option for pediatric pain management is the duragesic patch, which releases an opioid called fentanyl through the skin.

Full article at link: http://news.yahoo.com/fda-approves-opioid-painkiller-11-16-olds-144405563.html

 

[FuckWithRaw]

Got to get it while you can Purdue... $

doctors are to prescribe the medicine only for children who can already tolerate a minimum dose of 20 milligrams of oxycodone

kind of makes it seem like percocets are probably an option already but more choices never hurt + no acetaminophen is always nice.

 

[cj]

I'm always glad to see kids with terrible diseases having more options for pain relief. Let's be real an 11-16 year old kid with an opiate tolerance probably has a horrible disease.

 

[Keif' Richards]

I'm always glad to see kids with terrible diseases having more options for pain relief. Let's be real an 11-16 year old kid with an opiate tolerance probably has a horrible disease.

Really good point made where I could see a lot of people making this into some kind of joke. I went through a few heavy surgeries as a child and wasn't prescribed anything stronger than codeine (didn't find out I was unable to metabolize it until much later on... joke's on me I guess) until I was 15, so for an adolescent to be on a strong painkiller like oxycodone is probably an indicator of serious problems, assuming they're prescribing according to the guidelines.

 

[Cliffy78]

There's gonna be an uproar against this in the news now. Everytime I turn on the news it seems like they just want to do away with any and all opiods, wtf ! I'm so tired of everyone buying into the hysteria. It seems like as more states adopt mmj the louder the rhetoric gets. Mmj may work for some people but I'm guessing if we took a poll of patients with intractable 24/7 pain most would say mmj is not very effective compared with say... Hydro or oxy. Sry for getting a tad off track there...

 

[Felonious Monk]

I'm always glad to see kids with terrible diseases having more options for pain relief. Let's be real an 11-16 year old kid with an opiate tolerance probably has a horrible disease.

AGREED! All I'm seeing from the cannabis community and associated morons without 2 brain cells to run together is that this is more "big pharma" propaganda...

No kid is just "getting" OxyContin, they're really really fucking sick first, and the Doctor feels shitty about the whole situation. Plus, they were getting it before, it was just prescribed "off label," like every other medication on the market.

 

[DixiChik]

Mercy, I feel for kids, adults and senior peeps who must suffer the agony of never-ending pain. At least children glean compassion and hope for QOL from their medical team. If a disease cannot be eradicated through surgical intervention, I don't believe ANYONE should have to suffer. IF this med alleviates the child's (or adult or senior) pain, with proper supervision...LET THEM HAVE IT!

As for the reformulation (abuse proof?) of OxyContin...My PM says my GI system will not metabolize this version, so there's no point in my trying it. I'm stuck with IR (which I don't like) but need 24/7 relief. I feel so HOPELESS, as I've read where this med has the potential to replenish one's QOL. KUDOS, if it helps alleviate pain and suffering. LIFE without quality is no life at all, IME.