In August, the FDA approved the use of OxyContin, a powerful narcotic, for children with certain disorders. The decision remains controversial.
As described in the New York Times, opposition to the painkiller for kids has come from people concerned about the rampant abuse of opioids in the U.S., their potential for addiction and the consequent rising death rates. Although it might be more a sign of political pandering than statesmanship, the subject has even grabbed the attention of presidential candidates. Hillary Clinton said the FDA’s decision was “absolutely incomprehensible.”
The Times said the crux of the issue was whether the feds’ OK will lead to a proliferation of inappropriate OxyContin prescriptions for young patients. Although doctors have prescribed it for years as an off-label treatment for children suffering the severe pain of cancer or spinal-fusion surgery, it hadn’t been officially approved for those purposes.
“Off-label” means using a medical treatment for a patient or patient population that wasn’t represented in clinical trials and for which it was not approved. Although manufacturers may not promote such uses, doctors may use their judgment in applying any treatment to patients they believe would benefit.
The new OxyContin label will bear the warning about the risk of addiction, abuse and misuse.
In addition, the FDA’s approval will provide practitioners with “information about how to do it appropriately,” Dr. Stephen Ostroff told The Times. He’s acting commissioner of the FDA. By “appropriately,” he means information such as dosage recommendations, which usually are different for children using adult-tested drugs.
Many doctors welcome the approval, including Dr. Kathleen A. Neville, a pediatric oncologist who treats children with unremitting pain caused by cancer or sickle cell anemia. Neville told The Times, “Just because OxyContin has been abused or prescribed inappropriately doesn’t mean we should deprive the children who need the drug.”
To people who categorically say no child should ever be prescribed OxyContin, Neville said, “Come be one of my kids whose pelvis gets eaten out by cancer.”
The new label directs that OxyContin should be used as a painkiller only for children 11 or older who have been taking an opioid for at least five days. In other words, it’s not the first option doctors should exercise for pediatric pain control, and it’s not intended for short-term pain that results from an acute procedure, like the pain a teenager might get from having wisdom teeth pulled.
Much of the worry over a wider prescribing population is about how Purdue Pharma, the drug’s maker, will promote it.
“Manufacturers don’t pursue regulatory approvals simply to provide prescribers and patients with additional information,” Dr. G. Caleb Alexander, of the Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health in Baltimore, told The Times. “This approval allows Purdue Pharma to market and promote this product for use in children, and the obvious concern is this approval will change the pattern of use.”
A spokesman for Purdue Pharma said the company would not promote the new pediatric safety and dosing information for OxyContin to pediatricians or other physicians. But like so many other drugmakers, it doesn’t exactly have a clean record for legally promoting its wares.
In 2007, The Times pointed out, Purdue pleaded guilty to criminal charges that it misled doctors, patients and regulators about OxyContin’s potential to be abused.
Some critics of the FDA ruling objected to how it reached its decision. The normal routine for approval is to convene an independent advisory committee that hears experts testify about matters of significant public interest or that are potentially controversial. Three years ago, such a committee voted against approving another long-lasting opioid pain medication, Zohydro ER. But the FDA approved it anyway.
But in the case of pediatric OxyContin, no committee was ever formed to discuss it.
“I’m almost certain an advisory committee would have voted against a pediatric indication for OxyContin,” Dr. Andrew Kolodny, the executive director of Physicians for Responsible Opioid Prescribing, said in the story.
Alexander, who is chairman of another FDA committee, said that “it’s hard to imagine any scientific advisory board would have recommended approval of OxyContin for this purpose in the current environment.”
The FDA asked Purdue to conduct studies to examine the effects of OxyContin for kids, and required annual reporting for three years of adverse events including respiratory depression, overdoses and accidental exposure in patients 11 to 17 years old. Purdue also must report nationally representative data on the volume of OxyContin prescriptions for children younger than 17, who’s prescribing OxyContin and for what conditions.
Said Ostroff , “[W]e can have assurances that it’s being used in pediatric patients based on the labeling indication. In effect, this will give us much better information regarding how this drug is being used in children than we would ever have gotten through prior practices in off-label fashion.”