Research

Research

A Cross-Reference of PGx Drug-Gene Association Listings in FDA’s Table of Pharmacogenetic Associations and CPIC Clinical Guidelines

Conducted Quarterly by

Background

By uncovering new insights about how individual patient genetic variation can affect responses to various drugs, researchers in the field of pharmacogenomics (PGx) are establishing a foundation for genetically guided personalized medicine. While many drug-gene interactions have been studied, experts from different institutions sometimes have differing perspectives regarding the evidence of the validity of certain drug-gene interactions, and regarding how they should affect clinical decision-making.

Recognizing that conflicting information about drug-gene interactions may be confusing to health care leaders who want to use certain PGx tests to help guide treatment decisions as part of a fast-evolving personalized medicine approach, PMC published a peer-reviewed article on March 1, 2022, to flag and explore inconsistencies in the drug-gene associations listed in the U.S. Food and Drug Administration's Table of Pharmacogenetic Associations and widely consulted clinical guidelines published by the Clinical Pharmacogenetics Implementation Consortium (CPIC). The article also explored the perspectives of the Pharmacogenomics Knowledge Base (PharmGKB), which curates knowledge about the impact of genetic variation on drug responses for use by researchers and clinicians.

To help show how FDA and CPIC's perspectives on the field are evolving, faculty at Manchester University in Fort Wayne, Indiana, lead a team of Master of Science in Pharmacogenomics students through the following quarterly comparative analysis of FDA and CPIC's resources. By centralizing information about changes in drug-gene association information published by leading sources, this resource is designed to help researchers, genetic test developers, and health care decision-makers keep up with the latest thinking in the field.

Results: As of July 8, 2022

According to the most recent cross-reference analysis, 139 drugs are listed with PGx information in FDA's table, CPIC's guidelines, or both. The results show that FDA's table and CPIC's guidelines overlap through the inclusion of 44 drugs listed by both sources. It is important to note, however, that FDA and CPIC often list differing gene associations and/or dosing implications in connection with those 44 drugs.

Below, you will find links to an online list of the drugs included in FDA's table, CPIC's guidelines, and both; a Venn diagram showing the numbers of drugs included in FDA's table, CPIC's guidelines, and both; a PDF document analyzing the information provided for each of the 44 drugs listed by both sources; and lists of changes made to the drug-gene associations listed in the two sources since the publication of PMC's original comparative analysis on March 1, 2022.

  • DRUGS NAMED BY CPIC, FDA, OR BOTH: AS OF JULY 8, 2022
    • CPIC Guidelines Only (28 Drugs)
      CPIC Guidelines and FDA Table (44 Drugs)
      FDA Table Only (67 Drugs)
      1. Amikacin
      2. Atazanavir
      3. Desflurane
      4. Enflurane
      5. Fluvastatin
      6. Gentamicin
      7. Halothane
      8. Hydrocodone
      9. Isoflurane
      10. Ivacaftor
      11. Kanamycin
      12. Lovastatin
      13. Lornoxicam
      14. Methoxyflurane
      15. Ondansetron
      16. Paromomycin
      17. Peginterferon alfa-2a
      18. Peginterferon alfa-2b
      19. Pitavastatin
      20. Plazomicin
      21. Pravastatin
      22. Rasburicase
      23. Sertraline
      24. Sevoflurane
      25. Streptomycin
      26. Tenoxicam
      27. Tobramycin
      28. Tropisetron
      1. Abacavir
      2. Allopurinol
      3. Amitriptyline
      4. Atomoxetine
      5. Atorvastatin
      6. Azathioprine
      7. Capecitabine
      8. Carbamazepine*
      9. Celecoxib
      10. Citalopram
      11. Clomipramine
      12. Clopidogrel
      13. Codeine*
      14. Desipramine
      15. Dexlansoprazole
      16. Doxepin
      17. Efavirenz
      18. Escitalopram
      19. Fluorouracil
      20. Flurbiprofen
      21. Fluvoxamine
      22. Fosphenytoin
      23. Ibuprofen
      24. Imipramine
      25. Lansoprazole
      26. Meloxicam
      27. Mercaptopurine
      28. Nortriptyline
      29. Omeprazole
      30. Oxcarbazepine
      31. Pantoprazole
      32. Paroxetine
      33. Phenytoin
      34. Piroxicam
      35. Rosuvastatin
      36. Simvastatin
      37. Succinylcholine
      38. Tacrolimus
      39. Tamoxifen
      40. Thioguanine
      41. Tramadol
      42. Trimipramine
      43. Voriconazole
      44. Warfarin
      1. Amifampridine
      2. Amifampridine phosphate
      3. Amoxapine
      4. Amphetamine
      5. Aripiprazole
      6. Aripiprazole lauroxil
      7. Avatrombopag
      8. Belinostat
      9. Belzutifan
      10. Brexpiprazole
      11. Brivaracetam
      12. Carisoprodol
      13. Carvedilol
      14. Cevimeline
      15. Clobazam
      16. Clozapine
      17. Darifenacin
      18. Deutetrabenazine
      19. Diazepam
      20. Dolutegravir
      21. Donepezil
      22. Dronabinol
      23. Elagolix
      24. Eliglustat
      25. Erdafitinib
      26. Esomeprazole
      27. Fesoterodine
      28. Flibanserin
      29. Galantamine
      30. Gefitinib
      31. Hydralazine
      32. Iloperidone
      33. Irinotecan
      34. Isoniazid
      35. Lapatinib
      36. Lofexidine
      37. Meclizine
      38. Metoclopramide
      39. Metoprolol
      40. Mirabegron
      41. Mivacurium
      42. Nebivolol
      43. Nilotinib
      44. Oliceridine
      45. Pazopanib
      46. Perphenazine
      47. Pimozide
      48. Pitolisant
      49. Procainamide
      50. Propafenone
      51. Propranolol
      52. Protriptyline
      53. Rabeprazole
      54. Raltegravir
      55. Risperidone
      56. Sacituzumab
      57. Siponimod
      58. Sulfamethoxazole/ trimethoprim
      59. Sulfasalazine
      60. Tamsulosin
      61. Tetrabenazine
      62. Thioridazine
      63. Tolterodine
      64. Valbenazine
      65. Venlafaxine
      66. Viloxazine
      67. Vortioxetine

      Abbreviations: CPIC (Clinical Pharmacogenetics Implementation Consortium); FDA (Food and Drug Administration); PK (pharmacokinetics).
      Codeine and carbamazepine are listed in two FDA sections for different gene-drug associations.

  • WHERE DRUGS NAMED BY FDA AND CPIC APPEAR: AS OF JULY 8, 2022
    • Drugs Included in FDA's Table of Pharmacogenetic Associations and CPIC Clinical Guidelines: As of July 8, 2022


  • CHANGE LOG: APRIL 6, 2022 - JULY 8, 2022
    • DrugFrom:
      To:
      Amikacin
      Not listed by either source.CPIC's guidelines only.
      Gentamicin
      Not listed by either source.
      CPIC's guidelines only.
      Kanamycin
      Not listed by either source.CPIC's guidelines only.
      Paromomycin
      Not listed by either source.
      CPIC's guidelines only.
      Plazomicin
      Not listed by either source.CPIC's guidelines only.
      Streptomycin
      Not listed by either source.
      CPIC's guidelines only.
      Tobramycin
      Not listed by either source.CPIC's guidelines only.
      Fluvastatin
      Not listed by either source.
      CPIC's guidelines only.
      Lovastatin
      Not listed by either source.CPIC's guidelines only.
      Pitavastatin
      Not listed by either source.
      CPIC's guidelines only.
      Pravastatin
      Not listed by either source.CPIC's guidelines only.
      Belzutifan
      Not listed by either source.
      FDA's table only.
      Lansoprazole
      CPIC's guidelines only.CPIC's guidelines and FDA's table.
  • CHANGE LOG: MARCH 1, 2022 - APRIL 6, 2022
    • DrugFrom:
      To:
      Fosphenytoin
      CPIC's guidelines only.CPIC's guidelines and FDA's table.
      Phenytoin
      CPIC's guidelines only.
      CPIC's guidelines and FDA's table.
      Atorvastatin
      FDA's table only.CPIC's guidelines and FDA's table.
      Rosuvastatin
      FDA's table only.
      CPIC's guidelines and FDA's table.
      Viloxazine
      Not listed by either source.FDA's table only.
      BiomarkerFrom:
      To:
      NUDT15
      PharmGKB 2B
      PharmGKB 1A
      Drug-BiomarkerFrom:
      To:
      Succinylcholine-BCHE
      CPIC C/DCPIC B/C
      Tramadol-CYP2D6
      PharmGKB 1B
      PharmGKB 1A