NPA Responds to Report of Increased, Unintentional Pediatric Melatonin Ingestion
Over the past decade and particularly since the beginning of the COVID-19 pandemic, the use of melatonin supplements to address sleep issues has increased significantly by both adults and children. On Thursday, June 3, the Centers for Disease Control and Prevention (CDC) released a 10-year study that found a sharp increase in the use of melatonin by children specifically. According to the study, “During 2012–2021, the annual number of pediatric ingestions of melatonin increased 530 [percent] with a total of 260,435 ingestions reported. Pediatric hospitalizations and more serious outcomes also increased, primarily because of an increase in unintentional melatonin ingestions in children aged ≤5 years.”
As a result of this increase, the study reported, the amount of inadvertent poisonings among children increased throughout the 10-year period. ” … pediatric melatonin ingestions accounted for 4.9 [percent] of all pediatric ingestions reported to poison control centers in 2021 compared with 0.6 [percent] in 2012.”
In response to these findings, Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), pointed out, “This is an important finding, but officials do need to ensure that they have the most accurate data regarding melatonin. As the article clearly states, ‘the American Association of Poison Control Centers is not able to confirm the accuracy of each case reported to poison control centers, and individual chart review of all cases could not be performed. Finally, poison control center data do not include patient medical records or medical examiner reports, and confirmation of whether a death was secondary to toxic effects solely from melatonin or because of comorbidities was not possible.’”
Fabricant continued, “These deficiencies can lead to hazy and potentially misleading snapshots, which is precisely why the serious adverse event reporting system at FDA via Medwatch was established. Medwatch is the gold standard for detecting and alerting public health officials of potential concerns with products, and so far we have seen no action by the FDA as it relates to Melatonin. Melatonin has been used safely and continues to be under the normal conditions of use as labeled on the product. In the meantime, we remind everyone, including parents with children, who uses dietary supplements to always consult with their doctor or medical professional about what is best for their own personal health and wellness.”
In the study, researchers suggested, “Health care providers should advise parents regarding the safe storage and appropriate use of melatonin. Further, consumers and health care professionals should be encouraged to report any melatonin product–related adverse events to MedWatch, the FDA’s (U.S. Food and Drug Administration) medical product safety reporting program.”
For more information, visit www.cdc.gov.
