FDA Approves Oxycontin for Children Aged 11-16 years

The FDA has issued an approval for the prescription of Oxycontin for children between the ages of 11 and 16 (commonly known as “teens” and referred to as “adolescents” in the treatment industry).

Oxycontin is a brand of extended-release oxycodone, a synthetic opioid whose chemical structure mimics heroin. Oxycontin is the original brand of opioid painkiller from Perdue Pharma which was heavily over-prescribed in its early years, fueling a wave of addiction that has helped create an unprecedented demand for the much cheaper but chemically similar heroin.

The early “extended release” Oxycontin was easily manipulated so that large dose intended for gradual release throughout the day could actually be delivered all at once. An addict could access super doses of oxycodone from the pills, which made them valuable on the black market. As with most opiates and opioids, higher doses lead to higher levels of need, fueling addiction. The FDA revoked approval of that product under pressure from the addiction treatment industry and others, once more effective “extended release” methods were developed.

The approval of OxyContin for children followed 3 years of clinical trials, review, and approval by the Center for Drug Evaluation and Research (CDER) at the FDA. The review panel at CDER believes that OxyContin is “different from most other drugs in its class because it has been reformulated to better resist being crushed or dissolved”, which “discourages abuse by nasal or intravenous (IV)” use.

Only one other extended-release drug is specifically approved for extreme pain management in adolescents. Duragesic, a brand of fentanyl, is an extremely powerful opioid, estimated to be up to 100 times the strength of pure heroin. In 2015 over a dozen deaths were recorded in New Jersey when drug dealers introduced fentanyl-laced heroin into the street markets. Addicts sought the extreme highs promised by such a powerful drug, but almost immediately died from overdose.

Physicians are generally free to prescribe and use any drugs regardless of specific FDA approvals, using their own professional discretion (known as “off-label use” which is commonplace). Adult formulations of opioids, opiates, and other analgesics have been given to adolescents when necessary. The warnings and precautions for pediatric patients are the same as for adults.

Heroin addiction is now considered near epidemic levels in many states, including New Jersey, and heroin use is known to follow prescription opioid abuse when access to the prescription pills is suddenly shut off. Individuals addicted to the opioid pills find themselves desperate for an equivalent, and heroin is widely available, cheaper, and equivalent.

Heroin addiction is a now a serious problem among teens in New Jersey, where detox centers have to treat adolescents, and after school rehab programs provided intensive outpatient treatment designed to educate addicted teens and help them return to society free of dependency on drugs or alcohol.

Many more brands of opioids and opiates are now available on the market, but Purdue Pharma did clinical trials which support this FDA decision.

In 2012 Purdue Pharma began clinical trials on children, causing some to accuse the company of pursuing profits at the expense of child welfare.

In 2012 Purdue Pharma began clinical trials on children, causing some to accuse the company of pursuing profits at the expense of child welfare.

The FDA approval is very specific, requesting that doctors only prescribe these powerful opioids in severe cases of overwhelming need for pain relief, and when no other less-risky option exists. Medical professionals involved in treating addiction note that a small percentage of these patients will indeed develop an addiction to the Oxycontin, which must be managed.

While it is very important to note the very restrictive terms of this FDA approval of Oxycontin for adolescents as young as 11, it is also essential that everyone recognize the rise of prescription painkiller addiction followed over-prescribing by physicians, doctor shopping by patients, illegal sales of diverted drugs “lost” or “misplaced” by pharmacies, stolen from medicine cabinets, or sold by fixed-income seniors and others given easy access to prescription pain killers they didn't need, but sold for side income.

The Importance of FDA Oversight

It is essential that the FDA responsibly consider clinical trial research, and approve medicines that are needed, with strong guidelines that help protect our society from addiction. It is just as important, however, that we protect ourselves against a thriving illegal black market in drugs, provide monitoring and oversight to prevent the diversion of legitimate drugs into those illegal markets, educate people of the risks of addiction, and provide access to addiction treatment.

We must also educate physicians on the risks of prescribing opiates and opioids, and teach them to recognize substance abuse and dependency, while helping them refer patients to effective treatment.

Comments

  1. The rise in heroin related deaths and dependence is directly correlated with the DEA crackdown on prescrition drug abuse. Anyone who actually thinks that making it difficult for an opiare addict (or any addict) to get drugs will reduce the amounts of addicts has never met an addict.

    I subscribe to the school f thought that the DEA is ABSOLUTELY complicit in the increased numbers of heroin overdoses. Quite frankly I think more consideration needs to be given to STOP criminalizing a disease and leaving tax payers holding the bill. Why not legalize and tax said drugs and use those taxes to pay for treatment? It would cut down drastically on crime, incarceration rates and stigma.

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