FDA cautions consumers about genetic tests that claim to predict patients' responses to specific medications

FDA is alerting the public to its concerns about pharmacogenetic tests whose claims have not been reviewed by the agency, in particular about genetic tests that claim to predict how a patient will respond to certain medications.

FDA is alerting the public to its concerns about pharmacogenetic tests whose claims have not been reviewed by the agency, in particular about genetic tests that claim to predict how a patient will respond to certain medications. "Tests that make such claims that have not been evaluated by the FDA and are not supported by prescribing recommendations in the FDA-approved drug label, may not be supported by scientific and clinical evidence, and may not be accurate," note Jeffrey Shuren, MD, JD, director of FDA's Center for Devices and Radiological Health, and Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research, in a statement. An FDA Safety Communication details their concerns about health care providers and patients "inappropriately selecting or changing drug treatment based on the results from insufficiently substantiated genetic tests, which could lead to potentially serious health consequences for patients." Shuren and Woodcock note that these kinds of genetic tests claim to predict how someone will respond to specific medications used to treat conditions such as depression, heart conditions, and acid reflux. They add, "It is important to note that there are some drugs whose use can be aided by the results of pharmacogenetic information. In those cases, there is scientific evidence to support relationships between the genetic variant and how a patient responds to a drug, which has been reviewed by the FDA. The FDA-approved labeling for such a drug and genetic test provide health care providers with adequate information on how to use genetic information reported by the genetic test to manage medication treatment using the drug."