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.

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.

More: Treatment of opioid use disorder

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.”

NEXT: What needs to be done


Labeling, Feudtner said, “can provide both a confirmation of the best practice, the most evidence-based practice, as well as to constrain practices--to say that there are other ways of using this drug that are not to be employed.”

Feudtner, like Houck, noted that when the FDA expanded indication for OxyContin to some children aged 11 to 17 years, there was concern that there might be a boost in its use, but that does not seem to be happening.

Labeling, he argued, is but one small piece of how the nation should respond to the opioid epidemic, and the nation needs to also look at more effective use, including prescription monitoring.

What needs to be done

The systems that have to be thought through to strike the balance in opioid concerns include the FDA, the health system, the payment system, and law enforcement, Feudtner said. He also warned that we lack information about the risk and benefit for an individual and have even less certainty about specific interventions on misuse or pain on a population level, so that many of our thoughts about that are suspect. He cautioned that despite the very specific focus on pediatric opioid abuse, most pediatric patients who misuse don’t get their medications from a pediatric source.

During the final day of discussion, Sharon Hertz, MD, director of the FDA Division of Anesthesia, Analgesia and Addiction Products, said, “We are here because we know that there is a real paucity of data.” The agency never thought it would be simple, she said, but, “I think we didn’t adequately provide space for the complexities and the questions.”

Next: Timeline of the opioid epidemic

Among other things, Hertz noted, the session heard about data that showed that adolescents may be more at risk, but the agency would want to hear if there is some aspect of the adolescent risk with opioids to consider. Another question, she said, is how long studies should follow these children to determine if there were problems.

“What we can do is require these data be collected, which could then stimulate the interest of companies who have to fulfill these requirements to look for ways to do it,” she said.

Tamar Lasky, PhD, of MIE Resources of Baltimore, Maryland, cited the estimate that there are hundreds of thousands of opioid prescriptions for children for dental pain and indicated that might be a patient pool for clinical trials to provide answers about labeling. Looking at those prescriptions might also be an opportunity, she said, to learn about dentists’ prescribing and whether it is contributing to the problems.

Another suggestion concerned studying clinical screening tools or assessments that would be given after patients have started opioid therapy to determine if they know how to use it safely, as well as what the history of medication adherence is or whether there is a history of misuse.

In a submitted comment, several medical groups including the American Society of Anesthesiologists cited the AAP estimate that almost 50,000 children die in the United States each year and about a third of those deaths are attributed to conditions associated with substantial pain. In addition, there are many children with severe refractory pain from cancer, sickle cell anemia, musculoskeletal disorders, and other illnesses.

“To ensure that pediatric patients have access to opioid analgesics, we support reasonable regulatory approaches that incentivize prescribers to obtain the proper education and training to treat acute pain in children.”

They indicated the lack of pediatric pain specialists in many regions may require looking at alternatives, including web-based collaborations.

The FDA had said that it would not make determinations on any of the issues until later. Materials from the meeting, which may eventually include a transcript and a webcast, are available at under advisory meetings for September 15-16, 2016.

Ms Foxhall is a freelance writer in the Washington, DC, area. She has nothing to disclose in regard to affiliations with or financial interests in any organizations that might have an interest in any part of this article.

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