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Children's Medical Products: Reporting Problems to the FDA

When your child is sick, getting the right medication or medical device can make all the difference to your child’s health. Sometimes, however, medication or a medical device doesn’t work the way it’s supposed to, and your child may suffer from adverse side effects or product quality issues.

Consumers like you can play an important role in helping the Food and Drug Administration’s regulation of children’s medical products. By reporting the occurrence of any serious adverse effects or product quality issues your child has experienced related to a medication or medical device regulated by the FDA, you are helping the FDA to pinpoint problems and take actions to enhance the safety of the products it regulates.

Dianne Murphy, director of the FDA Office of Pediatric Therapeutics (OPT), notes that this is particularly important when it comes to medical products for children. Unlike trials for adult products, clinical trials for medical products for children often involve a smaller number of patients and as a result, problems related to the use of products may not be discovered until the products are used more widely. In some cases, a medication or device may have been tested on one age group but used for another age group which has not been tested.

So what should you include in your adverse event report to the FDA? It’s important to include details such as your child’s age, the product name, type, dose, method of administration and how long your child used the product, any other medications your child was also using or any other medical conditions present and the outcome. You don’t need to submit proof that the drug or device caused the problem experienced by your child. Give a clear statement about the event, followed by a detailed description of what happened.

Reports can be submitted online to MedWatch Reporting. Other methods of reporting can be found here.