As President Barack Obama pushes new initiatives to stem the rampant abuse of prescription opioids, controversy is still brewing over the recent approval by the Food and Drug Administration to allow children as young as 11 to be prescribed OxyContin, one of the most abused prescription drugs in Pennsylvania.
The FDA approved the new use in August. OxyContin, a controlled-release version of the opioid pain reliever oxycodone, is produced by Purdue Pharma of Stamford, Conn.
“People don’t jump straight from alcohol, or weed, to heroin,” said Jack Kabazie, system director of Allegheny Health Network’s Division of Pain Medicine and a fierce critic of the recent action. “Most often, there is a stop in between with pills.”
Eric Pahon, an FDA spokesman specializing in painkillers, said the approval was made in response to the FDA’s knowledge that physicians were already prescribing the drug off-label to treat children suffering from severe, long-term pain due to cancer, spinal fusion surgery and sickle cell anemia.
Previously, physicians had been using their best guesses about how much of the drug children should take. “Now doctors have access to explicit dosage information that will help them prescribe it appropriately,” he said.
The label also includes a warning that the drug carries the “risk of addiction, abuse and misuse,” and is not intended as a first resort for pain management. It indicates that patients must be stabilized on a short-term pain medication for five days prior to taking it.
The Obama administration, facing a nationwide epidemic of heroin and prescription drug abuse, announced last week that it would take steps to increase access to drug treatment programs and expand the training of doctors who prescribe opiate painkillers. There has been a steep increase in the number of heroin overdoses nationwide, resulting in a quadrupling of deaths in the past decade. Many who abuse heroin progressed to it after using prescription painkillers.
Concern about the recent FDA action also was addressed at a field hearing at Allegheny General Hospital on Oct. 15 convened by U.S. Sen. Pat Toomey, R-Pa., chairman of the Senate Finance Subcommittee on Health Care, to investigate the nation’s opioid/heroin epidemic that has seen overdose deaths in Western Pennsylvania soar.
Dr. Kabazie testified that he was against the FDA’s approval of extending OxyContin for children because he is wary that it will lead to physicians feeling more comfortable prescribing the drug.
“Clearly it’s effective; it’s a very potent narcotic. But when physicians see that something’s been approved by the FDA, they may start to think that it’s safe. And that’s not the case,” he said later in an interview with a reporter.
Dr. Kabazie went on to say that he takes issue with the fact that the FDA failed to specify a diagnosis for the medication.
“We did not specify particular causes of pain (such as cancer, spinal surgery, etc.) that are appropriate to treat with OxyContin, because it would be impossible to categorize all of those conditions,” Mr. Pahon said. “Remember, the label specifies pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. We use cancer and extensive surgical procedures as examples to show what types of situations OxyContin might be useful in, but there could be other conditions which fit these criteria. Thankfully, not many children experience the types of cancer pain, extensive trauma or surgeries that require long-term pain management.”
Asked in an interview why the FDA didn’t convene an independent advisory committee to vote on the drug’s pediatric approval, Mr. Pahon said the agency didn’t feel it was necessary.
“Advisory committees are consulted when we have novel scientific questions,” he said. “In the case of OxyContin, we already knew it was being prescribed to children. There wasn’t an unknown there.”
As part of the approval, Purdue Pharma will be required to study use of the drug for several years to track how, where, and why it is being prescribed. Mr. Pahon says this information will be used to ensure that the drug is being used as intended, and will inform future adjustments to the label’s specifications.
It’s still too early to tell whether the approval will lead to an increase in OxyContin prescriptions or whether the public backlash will reduce its use. According to Dr. Kabazie, outcry following last year’s pediatric approval of Zohydro, another opioid pain reliever, resulted in a significant reduction in prescriptions of that drug.
He says public opposition to the pediatric approval of OxyContin might put caution surrounding the drug “back where it should be.”
Raymond Pitetti, associate medical director of the emergency department at Children’s Hospital of Pittsburgh of UPMC, says his doctors haven’t had to use OxyContin, saying they turn most frequently to liquid Percocet or oxycodone. However, he says they typically do not treat children experiencing the levels of pain OxyContin is typically prescribed for.
“I have an almost visceral reaction to that drug because I know it’s something that’s highly addictive. Knowing that someone is using it in kids gives me pause.” Dr. Pitetti said.
“At the same time, if a family has child with cancer, and that child is in tremendous pain, there’s not much they can do. If OxyContin is what it takes, then that’s what you want to give.”
Correction: Updated Oct. 28, 2015: Comments by Eric Pahon, an FDA spokesman specializing in painkillers, were clarified about the reason the FDA did not specify specific causes of pain that are appropriate to treat with OxyContin.
First Published: October 26, 2015, 4:00 a.m.
