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