Reactions are Mixed to the Food and Drug Administration's OxyContin-for-kids Ruling

Reactions are Mixed to the Food and Drug Administration's OxyContin-for-kids Ruling

 (Novus reports to professionals in the treatment industry to help support those that work to handle the epidemic of addiction in the US.)

The Food and Drug Administration has approved the powerful and notorious opioid painkiller OxyContin for children as young as 11. Physicians who treat children with seriously painful conditions, especially pediatric oncologists treating end-stage cancer, have praised the decision. Many other physicians, however, as well as politicians and members of the public, are concerned that the FDA approval opens the door to more widespread prescribing of OxyContin to children in general. This could put them at risk for addiction, they say. Because OxyContin is an extended-release product, it makes the management of serious and chronic pain much easier - roughly one or two a day instead of three or four or more single-dose pills. But extended-release means a triple or quadruple amount of opioid per pill - dangerously attractive to abusers. As a result, OxyContin became notorious for being at the heart of America's stunning increase in painkiller addictions. And drug maker Purdue Pharma's introduction five years ago of an "abuse resistant" formulation has had only moderate success. A recent study found that the new OxyContin is not as resistant to abuse as hoped.

So why did the FDA approve OxyContin for kids?

According to Dr. Sharon Hertz of the FDA's Center for Drug Evaluation and Research (CDER), few pain management products provide information about their safety and effectiveness in pediatric patients, including several new pain medications recently approved for adults. Yet just as adults, pediatric patients also suffer terrible and debilitating chronic pain. "Thankfully, not many children experience the types of cancer pain, extensive trauma or surgeries that require long-term pain management," Hertz said. "To manage pain in pediatric patients, physicians often have to rely on their own experience to interpret and translate adult data into dosing information for pediatric patients." Because health care providers need more information on the safe use of drugs in pediatric patients, Hertz said, the FDA can use its authority to ask drug makers to conduct studies to obtain pediatric-specific information. In this case, the FDA asked Purdue to "perform studies evaluating safety and other important information about oxycodone and OxyContin when used in pediatric patients," Hertz said. "These studies supported a new pediatric indication for OxyContin in patients 11 to 16 years old, and provided prescribers with helpful information about the use of OxyContin in pediatric patients." Purdue's study resulted directly from the federal "Best Pharmaceuticals for Children Act" (BPCA) of 2002. This Act provides incentives to drug companies to study medications in pediatric patients. And it was under this Act that the FDA issued a "Pediatric Written Request" asking Purdue to study oxycodone and OxyContin in pediatric patients. "Pediatric patients don't usually have the same kind of chronic pain conditions as adults," Hertz explained, "so patients in the study were prescribed OxyContin in situations where they were expected to require pain management with an opioid for many weeks - for example, after extensive trauma, or after major spinal surgery or other types of major surgery to correct birth defects." Purdue conducted the tests, provided extensive data such as dosing levels, and the FDA approved OxyContin for children 11-to-16 who need "daily, round-the-clock, long-term" pain relief for which there is no alternative. Among the advices, 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. "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," Hertz said. "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." "OxyContin can continue to be used even after discharge following trauma, surgeries and other similar cases," she added. "Their parents and caregivers should be educated and given adequate information regarding the drug to ensure that it is administered according to the recommended measures." Other than OxyContin, the only other extended-release painkiller approved for children has been Duragesic, also known as fentanyl.

What are the critics saying, and why?

Among the critics of the FDA decision were Senator Joe Manchin (D-WV) and Vermont Governor Peter Shumlin. Shortly after the decision, Manchin sent a letter to Dr. Stephen Ostroff, Acting Commissioner of the FDA, in which he condemns the agency's decision. "This recent decision by the FDA to prescribe OxyContin to children as young as 11 years old is a horrifying example of the disconnect between the FDA approval process and the realities the deadly epidemic of prescription drug abuse are having on our communities," Manchin said. "We have years of evidence that shows that drug use at an early age makes a child more likely to abuse drugs later in life. We don't sell cigarettes or alcohol to minors, we should treat prescription drugs the same and protect our children from these harmful drugs." Governor Shumlin was equally adamant in his condemnation, citing the widespread prescription drug epidemic in America. "I was horrified when I learned of the FDA's decision...In the past 18 months, my state has invested millions of dollars in battling the threat that opiate abuse poses to families and our communities," Shumlin said. "We united behind the view that addiction is primarily a health care issue and that users need treatment, not prison cells. But Vermont continues to face the enormous personal and economic toll of drug abuse, just as the rest of the country does. Now is the time for the FDA to be a partner in reducing - not expanding - the availability of these drugs. Instead, it is doing the exact opposite." "While it's true that there are a small number of very ill children who may benefit from the extended-release nature of OxyContin, which allows for longer intervals between doses, the risks of legalizing this medication for kids are great," he added. "We know that teenagers are at a higher risk for addiction than adults because of their immature brain development. And we know that even if prescribed with the best of intentions, expanding the availability of these drugs in general has terrible consequences. It can lead to high rates of abuse, the use of other opioids such as heroin and, too often, death."

Opioid medications are a double-edged sword

We all know that narcotic painkillers cut both ways - they can cause addiction and even kill, but they are currently the only effective means of controlling pain for countless thousands of patients. For those suffering from serious, debilitating pain - especially chronic and end-of-life pain from diseases such as cancer - opioid medications help make life barely tolerable. And that goes for kids too, in a big way. On one hand, the CDC points out that roughly 15,000 people die every year of prescription painkiller overdoses - more than those from heroin and cocaine combined. And America loves its opioids - enough painkillers were prescribed in 2010 to medicate every American adult around-the-clock for a month. That year, more than 12 million Americans admitted using opioid painkillers "for non-medical" reasons - in other words, to get high. "Improving the way prescription painkillers are prescribed can reduce the number of people who misuse, abuse or overdose from these powerful drugs," the CDC said, "while making sure patients have access to safe, effective treatment." The official view, then - and this has also come from recent announcements from the White House and various health agencies - is to hang more of the responsibility on the prescribing practices of physicians, rather than on the availability - or not - of the painkillers themselves.

What's needed now are less risky alternatives to opioids

While doctors are exercising more care, there should also be more resources allocated to discovering more effective alternatives to opioids for pain management. A landmark federal study earlier this year found that long-term opioid use for chronic pain is actually ineffective and potentially harmful. The rote, thoughtless and indiscriminate prescribing of opioids that has taken place over the past 20 years clearly has raised the risk of dependence, addiction and overdose, the study said. The study, from the National Institutes of Health (NIH) Office of Disease Prevention, the National Institute of Neurological Disorders and Stroke, the National Institute on Drug Abuse and the NIH Pain Consortium, found:
  • No reliable scientific evidence supporting the safety and effectiveness of opioids for long-term treatment in chronic pain
  • No long-term comparative studies of opioid therapy vs. no opioid therapy have ever been conducted
  • Most randomized, controlled trials of opioids for chronic pain have been shorter than 6 weeks - none long enough to evaluate real long-term risk
  • Ample evidence has been found of harm from long-term opioid therapy, including increased risks of overdose and abuse.
Chronic pain treated with opioids was associated with:
  • opioid abuse
  • fractures
  • sexual dysfunction
  • myocardial infarction
  • and a host of other side effects
Higher doses, as opposed to longer term treatment, were also associated with increased risks of harm. As we reported not long ago in a blog, the NIH and related agencies have concluded that pain should be classified as a national public health crisis. Some years ago, Congress called for a whole new look at the problem. The result, after several years of study, is America's new National Pain Strategy, emphasizing not just new ways of treating it but new ways of how we should think about it.

The bottom line

Here at Novus, we help patients free themselves from the trap of prescription drug dependence and addiction, and get their lives back. Clearly, our experience shows that non-addicting, less dangerous alternatives to opioids for pain management are badly needed. Such solutions would still cut one way - alleviating the devastating pain, but not the other, harmful way. If you or someone you care for has a problem with prescription opioids, don't hesitate to give us a call. We are the leaders in helping people get their lives back.

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