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FDA Warns Against Genetic Tests Predicting Medication Response

Nov. 6, 2018

The FDA issued an alert warning against the use of 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.

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