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Friday, August 14, 2015

Oxys for Children Approved: An Uncalculated FDA Gamble

"Among adolescents who are prescribed OxyContin, a small but significant number are going to become addicted."

--Scott Hadland, specialist in adolescent medicine and substance abuse treatment at Boston Children’s Hospital and Harvard Medical School

The Food and Drug Administration has approved the powerful narcotic painkiller OxyContin for children as young as 11. While doctors who treat young cancer patients hailed the approval, others expressed concern that prescribing OxyContin to children could put them at risk for addiction.

Given the past record of mass addiction credited abusing (even using) OxyContin and the questionable history of FDA approval, the government seems to be making a gamble calculated with the knowledge of a clear view of attrition in mounting addictions and deaths. One must wonder if this approval will be strictly regulated and controlled to limit the potential destruction.

And, perhaps even more disturbing about the approval of the pain reliever for youth, is a revelation reported by Dr. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing. He said it's concerning that the FDA approved OxyContin for children without appointing an advisory panel to discuss the risks and benefits, a process traditionally used when the agency faces a controversial decision.

And, who did the FDA ask to perform a study? That's right, you guessed it -- the controversial manufacturer Purdue Pharma. The FDA asked Purdue to perform their own study to see if the drug could be used safely in children ages 11 to 16 with pain caused by cancer, trauma or major surgery.

Sharon Hertz, a physician with the FDA's Center for Drug Evaluation and Research, said as a condition of approval, the FDA is requiring Purdue to conduct a follow-up study examining rates of injury, overdose, accidents and medication errors in patients ages 11 to 17. The final study is due April 2019. April 2019? Does this sound responsible to anyone?

("FDA approves OxyContin for use by children ages 11 to 16." Fox News.
Associated Press. August 14, 2015)

Hertz said the FDA approved OxyContin for children this age who need "daily, round-the-clock, long-term" pain relief for which there is no alternative, and doctors should only prescribe OxyContin in children who have already been treated with opiate painkillers and who can tolerate at least 20 milligrams a day of oxycodone.

Hertz also stated that other than OxyContin, the only other long-acting painkiller approved for children is Duragesic, also known as fentanyl.

Hertz explained ...

"Children are not treated with opioids very often and usually it's only for a limited period of time with close supervision by health care professionals. Fewer daily doses may free patients for physical therapy appointments, allow them to go home from the hospital sooner and may help them to sleep through the night without waking up."

(Liz Szabo. "FDA approves OxyContin for kids 11 to 16." USA TODAY. August 14, 2015.)

These statements seem troubling considering the significant risk of addiction. Of course, pediatric cancer patients at the end of life aren't at risk of addiction, and the drug was developed for the pain suffered by such terminal patients. Who could deny the use of OxyContin as a way to ease children's suffering under such dire circumstances?

But, a casual attitude toward administering OxyContin to those with short-term medical needs could be catastrophic. It is common knowledge that doctors do prescribe opioids to adults such as OxyContin for a wide range of ailments, from post-surgical pain to arthritis and migraines.

Kolodny also reminded Americans that younger patients are at higher risk of addiction than are adults because the brain doesn't mature until about age 25. Consider the variables at play in prescribing OxyContin to children:

* Doctors should only prescribe OxyContin in children who have already been treated with opiate painkillers and who can tolerate at least 20 milligrams a day of oxycodone.

* When appropriate in a closely monitored pain management program, the doctor can then convert their patient over to an OxyContin dose that is tailored to their individual needs

* Doctors must screen patients for drug and alcohol abuse before prescribing OxyContin. 

* Doctors must check their state's prescription drug monitoring program, which allows them to see if patients have already received painkillers like OxyContin from other doctors.

* Parents must be in charge of giving children the medication, instead of allowing teens to administer their own painkillers.

* Parents must keep these powerful painkillers locked away at all other time.

I have to tell you that while I could support OxyContin for adolescent cancer patients suffering extreme pain, I am extremely wary of this new decision by the FDA. The opioid pain killer has already caused a health epidemic of addiction in America, and the following recent record heroin overdose numbers are a direct result of the availability of the drug.

If you consider the culpability of the FDA, Purdue Pharma, unscrupulous doctors, pharmaceutically uneducated parents, and greedy prescription opiate dealers, the move to approve OxyContin for children is full of risks.

And, just what the hell does "a small but significant number of adolescents becoming addicted" really mean?

Is this a similar promise to Purdue's first unconscionable claim that OxyContin was not addictive? I remember when they advertised the pain reliever as "The One to Stay With." Words cannot express my anger after realizing how many young Americans are already dead because of wicked lies and unimaginable greed. The pain ... the pill ... the administration ... the inevitable consequences.

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