The growth and developmental changes that occur during childhood can affect the safety and effectiveness of medical products when used in children. The FDA works to ensure pediatric safety is appropriately monitored and assessed in clinical trials conducted to support FDA approval. The safety information obtained from these clinical trials may be limited because the trials may be shorter in duration and may enroll fewer patients relative to when the medical product enters the market and is available for wide use. For this reason, the FDA maintains robust programs and systems for monitoring postmarket safety.
Postmarket safety reviews are particularly important for pediatrics. Pediatric product development studies, other than for vaccines or some childhood illnesses such as otitis media, tend to be small due to the limited number of children available for clinical trial participation. Additionally, once a product is approved for either adults or older children, it is frequently used off-label for younger children or for children with different medical conditions. Pediatric postmarket safety reviews enhance our understanding of the safety of a product and our assessment of the balance of risks and benefits of medical products used in children.
The FDA helps ensure medical products are safe when used in children. For example, the FDA’s Office of Pediatric Therapeutics coordinates the Congressionally-mandated postmarket pediatric-focused safety reviews of drugs, biologics, vaccines and humanitarian device exemption devices studied in the pediatric population. The FDA convenes meetings of the Pediatric Advisory Committee to obtain advice on the safety assessments for these products as needed. If safety concerns are identified, the FDA ensures the medical product labeling contains information about the risks. If an important new safety concern arises during postmarket surveillance, the FDA communicates the information to the public. See FDA Pediatric Safety Communications | FDA for pediatric-specific safety communications.
Healthcare professionals, patients, families and manufacturers play a vital role in helping the FDA monitor postmarket safety of medical products. If you suspect that an adverse event is related to an FDA-regulated product, file a report through MedWatch, the FDA’s adverse event reporting system. Detailed information about the product and the patient is imperative to allow the FDA to evaluate the risk.
If you suspect that an adverse event is related to a vaccine, file a report through the Vaccine Adverse Event Reporting System (VAERS).
- FDA Pediatric Safety Communications
- Pediatric Advisory Recommendations and Updates
- Pediatric Labeling Changes
- Consumer Updates: Children's Health
- Medwatch: The FDA Safety Information and Adverse Event Reporting Program
- Vaccine Adverse Event Reporting System (VAERS) (hhs.gov)
- FDA Adverse Event Reporting System (FAERS) Public Dashboard | FDA
- About Manufacturer and User Facility Device Experience (MAUDE) | FDA