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Pharmaceuticals / Regulatory Affairs

FDA Warns Against Genetic Tests Predicting Medication Response

Nov. 9, 2018
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The FDA issued an alert warning against using unapproved genetic tests to predict patient responses to medications.

The agency made the move in response to reports of DNA tests and software programs claiming they could predict the effectiveness or side effects of drugs such as antidepressants, heart medications and acid reflux drugs in certain patients. The claims are not based on any currently existing sufficient clinical evidence, the FDA said.

For example, some tests claim results can be used by doctors to identify which antidepressant would be most effective. There is no established relationship between DNA variations and the effectiveness of antidepressants, the FDA said, expressing particular concern about reports that some healthcare providers have already changed prescriptions based on genetic test results, which could put patients at risk.

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