Are Adverse Events from Pediatric Dermatology Products Getting Reported?
The FDA relies on consumers to report adverse events associated with product use to assist them in regulating product safety. A recent study looked into the consumer adverse event reports that were submitted to the FDA that had to do with cosmetics and personal care products (PCP) that are marketed for pediatric use. One objective of this study was to use this information to provide policy recommendations relevant to patient safety.
The study found that over a sixteen year period, 166 total adverse events were reported to the FDA for baby products. In addition, the reports dramatically increased in the final two years of the study (2014-16); baby powder increased to 52 reports from one report in the 3 prior years, and diaper and baby wipes increased to 42 reports from 3 in the 3 prior years. The majority of the reports specified a rash as the main adverse reaction.
The authors note that it was difficult to draw many conclusions because the number of reports was small for that time period. They also state that it is possible that media attention may have led to sudden burst of reports for baby powders and wipes.
They conclude that patient-reported adverse events must be supplemented with reports from manufacturers and providers to better identify problems. Most of these products are not subject to before-market approvals, so robust post-marketing surveillance and reporting is particularly important.
The authors note that because pediatric dermatology providers are often the first clinicians to encounter new trends in allergens and cutaneous adverse events in children, they are uniquely positioned to improve public safety by reporting more frequently.