Clinical Use of Pharmacogenetic Tests in Prescribing Psychotropic Medications
for Children and Adolescents
Several commercially available combinatorial pharmacogenomic tests are being marketed for psychiatric clinical practice. Commercial entities claim that the testing measures drug metabolism to guide medication choice and dosing to impact therapeutic response and side effects.
In October 2018, the Food and Drug Administration (FDA) issued a safety communication warning against the use of genetic tests with unapproved claims to predict medication response. The FDA stated that changing a patient’s medication regimen based on the results of a pharmacogenomic test leads to “inappropriate treatment decisions and potentially serious health consequences for the patient.”
Only a small fraction of the available commercial products have undergone randomized controlled trials in adults only.
Current studies are limited by:
- Potential conflicts of interest
- Small sample sizes
- Short duration of follow-up
- Lack of blinding
- Lack of appropriate control groups
Additionally, numerous factors affect medication response unaccounted for by genetic variation. Genetic variations are managed clinically with slow and thoughtful medication management.
Furthermore, pharmacogenomic testing provides little meaningful information when two or more medications are used concurrently.
The American Academy of Child and Adolescent Psychiatry recommends:
- Clinicians avoid using pharmacogenetic testing to select psychotropic medications in children and adolescents.
- Future high-quality prospective studies to assess the clinical significance of pharmacodynamic and combinatorial pharmacogenomic testing in children and adolescents.