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Doctors are worried about the recent approval of OxyContin for use in children as young as age 11.

The drug, which is a powerful painkiller, has been linked to the rise in heroin addiction and drug overdose deaths. The U.S. Food and Drug Administration (FDA) approved its use in children in August.

Although OxyContin was prescribed to children and adolescents prior to its approval in a practice known as "off-label use," it is likely to be prescribed much more widely now that it is officially approved, doctors say. [ 5 Surprising Facts About Pain]

Treating chronic pain, especially in children, can be incredibly challenging for doctors. There's no single, effective approach that makes pain go away for everyone, and for some patients, none of the existing drugs seem to work completely. In addition, some drugs commonly prescribed for people with chronic pain have the potential for addiction.

But even doctors with limited options for treating pain aren't happy with the decision.

"There really aren't many people that are applauding this decision," said Dr. Andrew Kolodny, a psychiatrist in New York City and the director of Physicians for Responsible Opioid Prescribing.

The majority of kids who will wind up getting OxyContin as a result of this decision will not be the appropriate patients, Kolodny told Live Science. Prior to the approval, OxyContin was already under fire for being overprescribed in adults.

Treating pediatric pain

In the past, doctors took a very biomedical approach to pain, said Dr. Tracy Harrison, a pediatric anesthesiologist and the medical director of the Pediatric Pain Rehabilitation Program at the Mayo Clinic in Minnesota.

The idea was that pain could be addressed by figuring out the right medication, and the right dose, for each patient, Harrison told Live Science. But pain - particularly chronic pain - is much more complex than that.

Simply using a medication, an injection, or in more extreme cases, surgery, in isolation doesn't address all of the other parts of patients' lives that can influence their pain, Harrison said. Sleep, anxiety, stress and activity levels can all play a role in both acute and chronic pain, she said.

In children and teens in particular, there's a significant psychosocial behavioral component, in addition to the physical aspect of pain, said Dr. Giovanni Cucchiaro, an anesthesiologist and the medical director for the Pain Management and Palliative Care Program at Children's Hospital Los Angeles.

If doctors look at the physical, psychological and social components of pain together, then most of the time they can manage chronic pain, Cucchiaro told Live Science.

There is no one single intervention that's always successful, he added. The best treatment comes from a combination of approaches that are individualized to each person, Cucchiaro said.

But not all patients - or doctors - have come around to this way of thinking.

A lot of patients, when offered counseling or breathing exercises, assume that doctors think their pain isn't real, Harrison said. "I have to tell them I know that the pain is real," she said.

Doctors often need to sit with patients for hours to explain the approach, she said. Indeed, it's far easier to just write a prescription, Harrison added. And sometimes patients or their parents may think that doctors are holding out on the medicine that will make the pain completely go away, she said. Unfortunately there is not one medication that can do that with consistency and the focus should be on maintaining function, even if some pain remains, she said.

Enter OxyContin

One of those medications that people think can make pain disappear is OxyContin.

While doctors agree that there are cases in which OxyContin is appropriate for use in children, many physicians believe those cases are few and far between. For example, doctors are not disputing the use of OxyContin for children who have severe pain or are nearing the end of their lives, such as children who have cancer or have undergone very serious surgeries.

"The fact is there are going to be times when you need to expose children to an opioid, and there are times when it should be OxyContin," Kolodny said.

But Kolodny asserted that the use of the drug should be limited to end-of-life care. "Outside of palliative care, there's a very limited role," he said.

Cucchiaro agreed. "It's very hard to say, 'I'm going to start a kid on OxyContin,'" he said.

The role for this drug might include treating children who have undergone major surgery, or had a traumatic accident, he said. But even for those kids, very few pediatric pain doctors would prescribe OxyContin long term, because "we know the problems with tolerance and dependence," he said.

Cucchiaro noted that if doctors do prescribe an opioid for a child, they're more likely to prescribe a short-acting drug, such as Percocet. (Percocet and OxyContin contain the same opioid ingredient, oxycodone, but unlike Percocet, OxyContin is extended-release, meaning its effects last much longer.)

Harrison also expressed uneasiness about OxyContin.

The use of the drug for chronic pain in children is especially concerning, she said. Many of her patients who have taken opioids were not able to function as normal teenagers do. The effects can be "debilitating" for some patients, she said. Instead of going to school and seeing their friends, they're staying in bed, she said.

Perhaps the biggest concern with OxyContin, and opioid painkillers in general, is the risk of addiction.

After a week on these drugs, the body becomes physically dependent on them, Kolodny said. And along with dependence, patients develop a tolerance, so they need higher and higher doses to achieve the same effect, he said.

Although it's hard to say how often children who take OxyContin will develop an addiction, the brain of an adolescent is more susceptible to becoming addicted to drugs, Kolodny said.

The brain does not fully mature until age 25, and there is good evidence that people who begin using drugs before that age are more likely to develop an addiction, he said. [ 10 Facts Every Parent Should Know About Their Teen's Brain]

Approval issues

One reason the FDA approval has made doctors uncomfortable is that they fear patients will think that doctors support the drug's use in children with chronic pain, Harrison said.

"It sends mixed messages to the public," she said. And patients may ask for the drug more directly, she said.

Indeed, the majority of medications that are prescribed to children are given off-label, Kolodny said. Other drugs, such as Percocet and Vicodin, are also given off-label to children, he said.

"The fact that OxyContin didn't have the indication for the use in children didn't stop doctors," he said. But now that OxyContin is approved - while other painkillers still aren't - people will be more likely to want to use OxyContin, Kolodny said.

Especially with the recent attention given to the United States' opioid-addiction epidemic, it seems puzzling to some that the FDA approved OxyContin for adolescent use.

"The main concern I have about the FDA's decision is that they bypassed the advisory committee," Kolodny said. According to the agency's website, the FDA brings in an independent scientific advisory committee of experts when an approval decision may be of significant public interest or controversial, or may require special expertise.

"I very strongly believe that had they brought it before a scientific advisory committee" that included addiction specialists and neurobiologists, it would not have been approved, Kolodny told Live Science.

Live Science reached out to the FDA for a comment on its decision to forego an advisory committee. FDA press officer Eric J. Pahon said, in part, "We are experienced in reviewing applications for pediatric uses. We can and do take issues to advisory committees when we need to. In this case, given our experience in reviewing these applications and given the data presented, we concluded that an advisory committee was not needed."

"To avoid an inefficient use of resources, we take pediatric applications to an advisory committee only when scientific issues arise that require the input of a committee. Pediatric studies are discussed by the FDA extensively prior to initiation by sponsors," Pahon told Live Science in an email.

Follow Sara G. Miller on Twitter @SaraGMiller. Follow Live Science @livescience, Facebook & Google+. Originally published on Live Science.

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OxyContin Approved for Kids, Worrying Doctors

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Doctors are worried about the recent approval of OxyContin for use in children as young as age 11. The drug, which is a powerful painkiller, has been linked to the rise in heroin addiction and drug overdose deaths. The U.S. Food and Drug Administration (FDA) approved its use in children in August.

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If adults are addicted why wouldn't children be?

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If adults are addicted why wouldn't children be?

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OETA Story on Youth and Oxycodone Addiction

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Addicted To OxyContin (oxycodone) | Addiction Epidemic

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It's legal, it's prescribed by doctors and it's tearing families apart. Tonight on A Current Affair, we show you the highly addictive painkiller creating addicts of everyday people. Silent drug wave in our suburbs Painkillers, Painkiller Medication, OxyContin, Oxycodone, OxyContin (oxycodone), Side effects of Oxycodone, Long term effects of OxyContin

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Oycodone, just like any other opioid, interacts with the mu opioid receptors (MOR) in the body, brain, and spinal cord. When activated the receptors bring pain relief by interrupting the communication of nerve pain to the brain. The Oxycodone elevates the levels of the neurotransmitter dopamine in the brain which causes the person taking the OxyCodone to be in a very deep euphoric state.  This causes the abuse potential to become so high.

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Babies born with Oycontin and other prescription drugs addictions

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Babies born with Oycontin and other prescription drugs addictions

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How could the FDA approve children to use Oxycontin when there are babies born addicted to prescription opioids? Some of these babies born with opioid addictions are dying early on too.

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Centers for Disease Control and Prevention

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White House Office on Drug Control Policy

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Babies Born Addicted to Prescription Drugs

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Amber Lyon investigates the new 'crack babies'- babies born addicted to prescription drugs. According to a new report from the Centers for Disease Control and Prevention, prescription drug overdose deaths in Florida are up a staggering 265% since 2003. But it's not just the deaths that have Florida officials worried; it's the births.

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Think "crack babies" but with oxycontin

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Michael Williamson/The Washington Post/Getty Images

In the late 1980s and early '90s, it was almost impossible to avoid hearing about the plight of "crack babies" - infants born to mothers who had used crack cocaine during pregnancy. These offspring were predicted to become a generation of either superpredator criminals or mentally disabled government aid recipients, unable to care for themselves.

Now, the New York Times reports on the children of mothers who misuse prescription painkillers like Oxycontin:

As prescription drug abuse ravages communities across the country, doctors are confronting an emerging challenge: newborns dependent on painkillers...

Infants like [this] may cry excessively and have stiff limbs, tremors, diarrhea and other problems that make their first days of life excruciating. Many have to stay in the hospital for weeks while they are weaned off the drugs, taxing neonatal units and driving the cost of their medical care into the tens of thousands of dollars.

Like the cocaine-exposed babies of the 1980s, those born dependent on prescription opiates - narcotics that contain opium or its derivatives - are entering a world in which little is known about the long-term effects on their development. Few doctors are even willing to treat pregnant opiate addicts, and there is no universally accepted standard of care for their babies, partly because of the difficulty of conducting research on pregnant women and newborns.

Sound familiar? The symptoms described in opiate-exposed babies are virtually identical to those of babies exposed to crack - even though, pharmacologically, cocaine is a stimulant and opiates are depressants. That's because most drug-exposed infants have other factors in common: they're typically born preterm, a condition that can cause similar symptoms even without drugs. Further, most drug-exposed babies have been exposed to more than just one drug. Most addicted mothers use multiple substances, and many "crack babies" were also exposed to opiates. ( More on Time.com: Top Ten Legal Drugs Linked to Violence)

So whatever happened to the generation of crack babies who prompted so much media hand-wringing? Although the Times story doesn't mention it, research ultimately found that crack exposure itself didn't cause significant problems for these children. The life outcomes of fetuses exposed to crack were more closely related to their parents' resources and behavior after they were born than to what happened to them in utero. Domestic violence during childhood was far more likely to be damaging, for instance, than drug exposure during the mother's pregnancy. Brought up in safe, loving homes, these children mainly did fine. Overall, in fact, the crack generation did fewer drugs and committed less crime than their parents had.

Ultimately, the data showed that a mother's crack use during pregnancy was as bad for her fetus as cigarette smoking. That may sound like no big deal, especially to a generation in which 30% to 50% of women smoked while pregnant. But smoking can cause prematurity, low birth weight, even stillbirth - all of the same problems attributed to crack cocaine. And 90% of mothers who have drug-exposed infants also smoke cigarettes.

Indeed, the Times story does note:

Experts say that since many drug users also smoke and abuse alcohol, not to mention that they face extenuating circumstances like poverty, it is difficult to tease out the effects of each substance on their offspring.

"Most of the literature suggests consistently that the drug exposure itself is not the primary concern," said Karol Kaltenbach, a professor at Jefferson Medical College in Philadelphia who studies addiction in pregnant women. "It's the cumulative effect of the drug-using lifestyle - poverty, chaos in the home, domestic violence. All those things affect development."

But the story doesn't address the damage of being labeled a "crack baby" (or an "Oxycontin baby") to begin with - which turns out to be even more damaging than the drug. Research has shown that caregivers who were told that a child was a crack baby tended to interpret the baby's normal behavior as disobedient and pathological, and thus became more punitive. Cases of severe child abuse were even ignored because the children's behavior and medical problems were seen as the result of crack exposure, not parental abuse or neglect. ( More on Time.com: Will the Government's Drug 'Take-Back' Do Anything to Reduce Misuse?)

Focusing on the new generation of "Oxycontin babies" could create the same problem. And the media coverage makes me wonder: why don't we pay more attention to the harm done by the most common and most dangerous recreational drug used during pregnancy, alcohol?

Unlike opiates or crack, heavy drinking is known to produce a characteristic and incredibly damaging suite of defects in infants. Fetal alcohol syndrome (FAS) is marked by specific facial defects, heart and lung defects, intellectual disability (formerly called mental retardation) and impulse-control problems. In babies with FAS-related brain damage, the corpus callosum - the broad bundle of nerve fibers that connects the left and right sides of the brain and allows them to communicate - may be abnormally small or missing entirely. Alcohol exposure can also cause a range of other permanent birth defects - brain damage without the facial defects, for instance - known collectively as fetal alcohol spectrum disorder.

Fetal alcohol syndrome is the most common known cause of intellectual disability - more common than Down syndrome - and affects 40,000 children each year. But in part because it's not associated with the latest craze in drug use by teenagers, it's virtually absent from the media. Perhaps rather than worrying about potential subtle damage associated with opiates, we might focus on reducing the known severe harm linked with heavy drinking.
Related Links: Does Suffering From Withdrawal Really Mean You're Addicted? Pharmageddon Deferred: New Measures to Stop Opioid Abuse

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Are Oxycontin Babies This Decade's Crack Babies?

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In the late 1980s and early '90s, it was almost impossible to avoid hearing about the plight of "crack babies" - infants born to mothers who had used crack cocaine during pregnancy. These offspring were predicted to become a generation of either superpredator criminals or mentally disabled government aid recipients, unable to care for themselves.

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Christopher Oates died of a Heroin addiction and it all started with him abusing OxyCodone. Another child from his high school explained that all of the cool kids would go to these house parties and the OxyCodone would be out and available to use.  They would crush it up and snort it.  Christopher ended down the wrong path. After abusing high dosages of OxyCodone, it was not enough for him to experience the high he wanted. He turned to Heroin, which is another opioid but stronger.

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"The pharmaceutical company behind OxyContin is paying dozens of clinical sites to document the effects of the highly addictive painkiller on children as part of an effort to secure a Food and Drug Administration approval to label the drug for use by kids ages six and up, according to a report published by The Daily.

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Medically reviewed on January 30, 2018.

What is OxyContin?

OxyContin (oxycodone) is an opioid pain medication, sometimes called a narcotic.

OxyContin is used to treat moderate to severe pain.

OxyContin extended-release tablets are used for around-the-clock treatment of pain. They are not for use on an as-needed basis for pain.

Important Information

You should not use OxyContin if you have severe asthma or breathing problems, or a blockage in your stomach or intestines.

Oxycodone can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
Taking OxyContin during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Fatal side effects can occur if you use OxyContin with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Before taking this medicine

You should not use OxyContin if you are allergic to oxycodone, or if you have:

You should not use OxyContin unless you are already using a similar opioid medicine and are tolerant to it.

OxyContin should not be given to a child younger than 11 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

drug or alcohol addiction, or mental illness;

liver or kidney disease;

urination problems; or

problems with your gallbladder, pancreas, or thyroid.

Some medicines can interact with oxycodone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use OxyContin while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Do not breast-feed. Oxycodone can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.

How should I use OxyContin?

Take OxyContin exactly as prescribed. Follow all directions on your prescription label. Oxycodone can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take OxyContin in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Oxycodone may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away OxyContin is against the law.

Stop taking all other around-the-clock narcotic pain medicines when you start taking OxyContin extended-release tablets.

Take OxyContin with food.

Do not crush, break, or open an OxyContin extended-release tablet. Swallow the tablet whole to avoid exposure to a potentially fatal dose. Never crush or break an OxyContin pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This can cause in death.

You should not stop using oxycodone suddenly. Follow your doctor's instructions about tapering your dose.

Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Since OxyContin is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An oxycodone overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.

What should I avoid while using OxyContin?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how oxycodone will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Avoid medication errors. Always check the brand and strength of oxycodone you get from the pharmacy.

OxyContin side effects

Get emergency medical help if you have signs of an allergic reaction to OxyContin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, oxycodone can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

noisy breathing, sighing, shallow breathing;

a slow heart rate or weak pulse;

a light-headed feeling, like you might pass out;

confusion, unusual thoughts or behavior;

seizure (convulsions);

severe constipation; or

low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, confusion, fever, sweating, fast heart rate, chest pain, feeling short of breath, muscle stiffness, trouble walking, or feeling faint.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common OxyContin side effects may include:

drowsiness, headache, dizziness, tired feeling; or

constipation, stomach pain, nausea, vomiting, loss of appetite.

mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

OxyContin dosing information
Usual Adult Dose for Pain:
Initial:
Controlled Release (CR): 10 mg orally every 12 hours.

Maintenance:
CR: 20 mg to 640 mg per day in patients with cancer pain. The average total daily dose is approximately 105 mg per day. Cancer patients with severe pain may require "as needed" rescue doses of the immediate-release form of oxycodone to supplement the controlled-release form.
Usual Geriatric Dose for Pain:
Maintenance:
CR: 20 mg to 640 mg per day in patients with cancer pain. The average total daily dose is approximately 105 mg per day. Cancer patients with severe pain may require "as needed" rescue doses of the immediate-release form of oxycodone to supplement the controlled-release form.

Some drugs can raise or lower your blood levels of oxycodone, which may cause side effects or make oxycodone less effective. Tell your doctor if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

other narcotic medications - opioid pain medicine or prescription cough medicine;

drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine.

This list is not complete. Other drugs may interact with oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use OxyContin only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer

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oxycontin side effects oxycodone severe pain narcotic

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Oxycontin Uses, Side Effects & Warnings - Drugs.com

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Medically reviewed on January 30, 2018. OxyContin (oxycodone) is an opioid pain medication, sometimes called a narcotic. OxyContin is used to treat moderate to severe pain. OxyContin extended-release tablets are used for around-the-clock treatment of pain. They are not for use on an as-needed basis for pain.