Drugs

FDA Warns About Some Genetic Test Predictions

FDA says healthcare providers and patients should be aware that claims for many genetic tests to predict a patient’s response to specific medications have not been reviewed by the agency and may not have the scientific or clinical evidence to support such use for most medications. An agency safety communication cautions that changing drug treatment based on results from such a genetic test could lead to inappropriate treatment decisions and potentially serious health consequences for the patient.

The agency has become aware, the notice says, of genetic tests that claim results can be used to help doctors identify which antidepressant medication would have increased effectiveness or side effects compared to other antidepressant medications. However, the notice says, the relationship between DNA variations and the effectiveness of antidepressant medication has never been established. “Patients and healthcare providers should not make changes to a patient’s medication regimen based on the results from genetic tests that claim to predict a patient’s response to specific medications, but are not supported by sufficient scientific or clinical evidence to support this use,” the notice says.

FDA says there are a limited number of cases for which at least some evidence exists to support a correlation between a genetic variant and drug levels in the body, and this is described in the labeling of FDA approved or cleared genetic tests and FDA approved medications.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

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FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome