Clopidogrel
Pharmacogenomic Information in the Context of the FDA-Approved Drug Label*
The clopidogrel label mentions genetic testing as it relates to treatment with this drug.
Excerpt from the clopidogrel drug label:
"Pharmacogenetics: Based on literature data, patients with genetically reduced CYP2C19 function have lower systemic exposure to the active metabolite of clopidogrel and diminished antiplatelet responses, and generally exhibit higher cardiovascular event rates following myocardial infarction than do patients with normal CYP2C19 function (see CLINICAL PHARMACOLOGY: Pharmacogenetics)."
Twenty-one studies involving 4,520 subjects have shown that CYP2C19*2, CYP2C19*3, and other CYP2C19 loss-of-function alleles are associated with diminished antiplatelet responses to treatment with clopidogrel. CYP2C19 participates in the formation of both the active metabolite of clopidogrel and the 2-oxo-clopidogrel intermediate metabolite. Individuals with CYP2C19 loss-of-function alleles have reduced exposure to the active metabolite of clopidogrel, leading to less platelet inhibition or higher residual platelet reactivity. Key publications on pharmacogenetic studies of response to clopidogrel include: [PMID:19106083, PMID:19106084, PMID:19108880, PMID:19193675].
The clopidogrel drug label was updated on 5/5/2009 to include pharmacogenetic information. For the complete updated drug label text, see the Clopidogrel drug label PDF
Pharmacogenomic Diagnostic Testing
The information below is provided for educational purposes only and does not constitute an endorsement of any listed test or manufacturer.
| Drug | PGx Diagnostic Test¹ | Gene | Variants Assayed | FDA Document² |
|---|---|---|---|---|
| clopidogrel, esomeprazole, omeprazole, phenytoin, others | Roche AmpliChip Cytochrome P450 Genotyping test and Affymetrix GeneChip Microarray Instrumentation System | CYP2C19 | CYP2C19*1, CYP2C19*2, CYP2C19*3 | CLIA Document and 510(K) PMN Number K043576 |
¹ Entries in this column link to test manufacturer's website.
² Information in this column was found using searches of the entire FDA website (http://www.fda.gov/search.html), searches of the FDA CDRH CLIA database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/Search.cfm), or searches of the FDA CDRH Premarket Approval Database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm).
Table updated 10/19/2009.
Related PharmGKB resources:
| Drug information: | Clopidogrel |
|---|---|
| Variants of PGx interest: | CYP2C19*2, CYP2C19*3, CYP2C19*4(rs28399504), CYP2C19*5(rs56337013), CYP2C19*6, CYP2C19*7, CYP2C29*8 (rs41291556) |
| Very Important Pharmacogene (VIP) pages: | CYP2C19 VIP |
| Allele frequency information: | CYP2C19*2(rs4244285), CYP2C19*3(rs4986893), CYP2C19*4(rs28399504), CYP2C19*5(rs56337013), CYP2C29*8 (rs41291556) |
| Gene pages: | CYP2C19 |
| Gene Variants pages: | CYP2C19 variants |
| Pathways: | Antiplatelet Drug Clopidogrel Pathway (PK), Platelet Aggregation Pathway (PD) |
| Datasets: | Clopidogrel datasets |
| Genetics information: | All variant annotations mentioning clopidogrel |
| Literature: | Publications related to clopidogrel and CYP2C19 PGx |
*Disclaimer: The contents of this page have not been endorsed by the FDA and are the sole responsibility of PharmGKB.
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