FDA Publishes Details on Gene-Drug Interactions

February 28, 2020

The FDA has released a new table listing certain gene-drug interactions backed by scientific evidence that appear on agency-approved drug labeling.

The table, which was created by CDER and CDRH, lists pharmacogenetic associations the agency has evaluated and believes could impact subgroups of patients with certain genetic variants.

For example, the table lists abacavir, an HIV antiviral, as resulting in higher adverse reaction risk in patients with the HLA-B*57:01 allele, and warns that they should not be prescribed the medication.

The inclusion of a particular gene-drug interaction “does not necessarily mean FDA advocates using a pharmacogenetic test before prescribing the corresponding medication, unless the test is a companion diagnostic,” the agency noted.

The FDA said the table is incomplete but was released to inform clinicians, patients and test developers while scientific evidence continues to be studied.

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