> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 23andMe Clearance for Metabolism Report on 2 Drugs
- URL: https://www.fdaweb.com/23andme-clearance-for-metabolism-report-on-2-drugs/
- Published: 2020-08-18T12:00:00.000Z
- Updated: 2026-09-14T16:25:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147459

FDA has cleared a 23andMe 510(k) for a pharmacogenetics report on interpretive drug information for two drugs — heart drug clopidogrel and depression drug citalopram. The clearance modifies the labeling of the company’s 23andMe CYP2C19 Drug Metabolism Report, removing the need for confirmatory testing and allowing the company to provide interpretive drug information based on genetic factors. “Individuals with certain genetic variants impacting drug metabolism by the CYP2C19 enzyme may experience reduced efficacy or increased chances of side effects from these medications, which could lead to life-threatening adverse events, such as cardiac problems,” the company says. The clearance allows 23andMe to give consumers information to share with their doctors “through accurate variant detection and clinically validated pharmacogenomic associations, consistent with the FDA-approved drug labels for both of these medications,” it adds.