What is the evidence?

Brain and Behavior, PLLC believes in the importance of practicing evidence based medicine and offering our patients the most up to date care. Many individuals have asked about Pharmacogenetic testing. Genetic testing to guide treatment in the future holds enormous potential in benefiting patients, but at this time it does not appear to have the scientific evidence to meet the standard of care.

The issue has become concerning enough that the United States Food & Drug Administration (FDA) has sent warning letters to companies for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness. The tests claim to predict patients’ responses to specific medications based on genetic variants. Selecting or changing drug treatment in response to the test results could lead to potentially serious health consequences for patients.

What does the FDA say?

The FDA is alerting patients and health care providers that claims for many genetic tests to predict a patient's response to specific medications have not been reviewed by the FDA, and may not have the scientific or clinical evidence to support this use for most medications. Changing drug treatment based on the results from such a genetic test could lead to inappropriate treatment decisions and potentially serious health consequences for the patient.

Recommendations for Patients:

• Do not change or stop taking any medicine based on a report from a genetic test you took on your own. Discuss the results of the genetic test with your health care provider, including whether the medication label includes information on how to use genetic information to determine dosage, and whether your health care provider recommends changes to your treatment. Medicine should always be taken as prescribed by your health care provider.
• Be aware that most genetic tests that make claims about the effects of a specific medicine are not supported by enough scientific information or clinical evidence.