How do you know if your child has been prescribed an 'off-label' medicine?
You could ask your doctor or pharmacist, or simply check the package insert (PI) that came with the medication. In the PI, look for a section called 'Indications and Usage' or 'Pediatric Use' and see what ages are listed. Remember that just because your child is younger than the listed age doesn't mean that the medication isn't safe and you shouldn't stop it without talking with your doctor.Downsides of 'off-label' medicine use
One big downside is that doctors sometimes have to estimate the dosage to give younger children based on the commonly used dosage for older children and adults. This might lead to children getting too much or too little medicine.Another downside is that if your doctor doesn't feel comfortable using drugs 'off-label' then your child might not be getting the best treatment available. Your doctor might be using an older medication with more side effects or your child might not be receiving any medication at all.
The Pediatric Drug Rule was instituted by the FDA to try and get drug companies to test their drugs in children. The Best Pharmaceuticals for Children Act also works 'to improve the safety and efficacy of pharmaceuticals for children.' Hopefully they will lead to more drugs being tested and approved for use in children so that they don't have to be used off-label anymore.
