FDA: More data needed on opioid use in kids
The lack of data available for pediatric trials and the effects of opioids in pediatric patients, were major points in the discussion in a 2-day FDA advisory committee meeting. The committee and the FDA discussed the challenging analgesic needs of the pediatric population and how to best address the issues.
Charles Berde, MD, of Boston Children's Hospital gave a warning that children can develop a "profound opioid tolerance" and continued use of these drugs can lead to discontinuation syndrome in infants and children. However, FDA current policy requires evidence of efficacy and most available evidence comes from trials in adults.
Clinical observations have highlighted adults have some epidemiologic differences in their responses to pain. Chris Feudtner, MD, of Children's Hospital of Philadelphia, disagreed that the opioid epidemic needs to be examined from both an individual and a population point of view, but that population concerns should not be the deciding factor in the labeling of a medication. He said, "FDA should not be asking for longer labels. The label shouldn't be about whether that medication is going to disappear from your medicine cabinet at some point". "We can address this problem through prescribing practices, but it should not be a labeling issue."
He warned the committee not to "overstep" regulatory requirements and take on other tasks, such as public health considerations, just because "other players have stepped away," and restated that the issue is about drug regulation, not trying to control a public health problem. Clinicians lack the data on the safety and efficacy of opioids in the pediatric population which were issues the committee was asked to address.