Experts concerned over OxyContin approval for kids

When the pain drug OxyContin (oxycodone) was approved by the 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 Cliffside Malibu Treatment Center, 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 tells Behavioral Healthcare. “We should be better advocates for proven alternatives to opioid pain therapies that do not carry risk or unknown consequences.”

Addictions psychiatrist Alkesh Patel, MD, at Mountainside Treatment Center, 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, and the misuse and addiction potential of opioids, given this uncertain, but possible vulnerability in children,” Patel says.

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, MD, addiction psychiatrist, Gateway Rehab, says he personally witnessed the initial explosion of OxyContin addiction and overdose deaths in the Pennsylvania community in the late 1990s and has concerns about long-term effects for the 11 to 17 year-old 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 they were 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. That raises strongly my concern about prescription opioids becoming more available for children,” Capretto says.

The concern extends beyond the medical community as well. Senator Joe Manchin (D-W.V.) sent a searing letter to the FDA’s acting commissioner this week, saying the agency should be “ashamed of itself for this reckless act.” He is also calling for a Senate investigation into the OxyContin decision.