When the pain drug OxyContin (oxycodone) was approved by the Food and Drug Administration (FDA) recently for use in children ages 11 to 17, there was a significant amount of outrage among clinical experts, congressional leaders and patient advocates, who could easily envision a child becoming addicted to this Schedule II drug—either while under a physician's care or later in life. Experts in the addiction field know all too well that the adolescent population is especially vulnerable to prescription drug addiction.
The decision is concerning to the behavioral health community and is indicative of some larger, ongoing trends, which include more potent and potentially addictive medications receiving FDA approval and the overprescribing of pain medications in the United States.
Constance Scharff, PhD, senior addiction research fellow and director of addiction research at the Cliffside Malibu treatment center in California, says there's no telling the harm OxyContin could potentially cause for a young child's brain development. Scharff also questions whether the short-term benefits of the new indication outweigh the long-term risks.
“We have no real research into either of these questions, and we should before we give this or any medication to children,” Scharff says. “We should be better advocates for proven alternatives to opioid pain therapies that do not carry risk or unknown consequences.”
Scharff adds, “We should really be looking at things like acupuncture as a first line in pain management because it is low cost, proven effective for many types of pain management and has few side effects (possible local bruising is the most common problem). But who wants to put money into acupuncture studies when there is so much money to be made in pharmaceuticals?”
Addictions psychiatrist Alkesh Patel, MD, who works at Mountainside Treatment Center in Connecticut, says the same health warnings that apply to adult use of OxyContin must be applied for pediatric use, while also considering stricter measures.
“The use of OxyContin in children should outline specifically which pain syndromes it would be most helpful for, and pediatricians and primary care physicians should be required to attend specific continuing medical education surrounding treating pain in children, and education about prescribing opioids, given this uncertain but possible vulnerability in children,” Patel says.
Adds Damon Raskin, MD, a board-certified addiction specialist and Cliffside Malibu's medical director, “These dangerous medications should only be given to kids as a last resort for severe pain when nothing else has worked. The best safeguard would be that only specialists such as pediatric pain management specialists or anesthesiologists would be able to prescribe these drugs after they have done extra training.”
Balancing risk and benefit
Manufacturer Purdue Pharma is obligated by the FDA to conduct post-market studies to evaluate the pediatric use in the real world and to document long-term, adverse effects.
Neil Capretto, DO, medical director of Gateway Rehabilitation Center in Pennsylvania and Ohio, says he personally witnessed the initial explosion of OxyContin addiction and overdose deaths in Pennsylvania in the late 1990s and has concerns about long-term effects for the 11-to-17 population.
“I clearly understand and support the need to adequately treat severe, torturous pain in people of all ages, and that would include children with terminal cancer or other imminent end-of-life conditions,” Capretto says. “However, this would only include an extremely small percentage of children with pain and should be a rare exception. I'm hopeful that it would not evolve into a routine prescription for a sprained ankle from playing soccer.”
He is concerned about prescribing patterns for OxyContin. Some physicians could likely repeat the overprescribing seen with adults, he says, even though the medical community is clearly more mindful of the potential problems with opioid pain medications today than it was 15 years ago.
“However, based on the many new patients I see every week with prescription opioid addiction, I know that there remains a large percentage of the medical community that still has a long way to go on the learning curve,” Capretto says. “That raises strongly my concern about prescription opioids becoming more available for children.”
The concern extends beyond the medical community as well. U.S. Sen. Joe Manchin (D-W.Va.) sent a searing letter to the FDA's acting commissioner last week, saying the agency should be “ashamed of itself for this reckless act.” Manchin is calling for a Senate investigation into the OxyContin decision.
Editor Gary A. Enos contributed to this article.
Get the latest information on Ethics and other valuable topics from renowned speakers that stand out as pioneers in their fields, best-selling authors, and leading experts at the leading summit for advanced clinical training.