Data lacking on labeling of opioids for kids
The US Food and Drug Administration (FDA) recently furthered the discussion of the mind-numbing, myriad issues around the use of opioids in children.
In materials introducing a 2-day meeting of 3 FDA advisory committees in September, the agency said, “There are few analgesic products labeled for use in pediatric patients aside from the nonsteroidal anti-inflammatory drugs indicated for juvenile rheumatoid arthritis. As a result, there is an unmet need for pediatric-specific labeling of analgesics to assist clinicians in proper patient selection and in determining the appropriate dosing for their patients.”
The agency had asked for information on issues including selection of the type of patient for these drugs; the appropriate patient for study of immediate-release or extended/long-acting opioid analgesics; the extrapolation of efficacy from adults to children; and the safety concerns surrounding the use and study of opioids in children.
In background materials, the FDA said, “In the US outpatient retail setting, pediatric patients 16 years of age and younger accounted for approximately 4% (2.5 million patients) of the total 66.5 million patients of any age who received dispensed prescriptions for opioid analgesics in 2015. The majority of pediatric patients were ages 7 to 16 years. There was a 34% decrease in the number of pediatric patients from 2011 to 2015.”
Risks vs benefits of opioids
At the actual session, participants discussed the lack of data on the risks versus benefits more than anything else.
Connie Houck, MD, representing the American Academy of Pediatrics (AAP) surgical specialty panel, told the meeting, “We are increasingly concerned that there is inadequate information to inform our care of postoperative pain,” in terms of both overtreatment and undertreatment of pain.
A lack of pharmacokinetic and pharmacodynamic studies of opioids in infants and children has made treatment of postoperative pain in children problematic, she said, and undertreatment of pain may put patients at further risk of long-term physical and psychological effects.
Houck noted, as did other speakers, that recent guidelines from the Centers for Disease Control and Prevention do not provide information on use in children aged younger than 18 years.
One illustration of the need for information is the fact that more and more parents are asking surgical specialists not to treat their children with opioids for postoperative pain because of concerns about addiction, said Houck, a pediatric anesthesiologist for Boston Children’s Hospital, Massachusetts. In addition, she said, advances in repairing congenital defects have also increased the need for such understanding.
On the other hand, Houck said, “There is no evidence that providing appropriate labeling of opioids in children increases use.”
New labeling is needed
According to Houck, pediatric surgeons recommend “robust studies of all opioid analgesic agents in order to provide appropriate labeling of opioid medications for use [in] infants, children, and adolescents in the perioperative period."
Houck also called for education of providers on acute pain in children, for all age groups and inpatient and outpatient surgery, including multimodal approaches for perioperative pain control. In addition, she said, surgical specialists and dentists need to know how to counsel parents about both use and disposal of unneeded meds.
Chris Feudtner, MD, PhD, of the Children’s Hospital of Philadelphia, Pennsylvania, said he is keeping his eye on 2 groups: adolescents and young adults who take opioids in a prohibited, harmful manner, and children at risk of having inadequately relieved severe pain. Nevertheless, he argued, labeling is not for the purpose of trying to strike this balance. Labeling, he said, “has a fiduciary interest of providing evidence-based guidance for individual level decision making.”