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: September 28, 2022

According to the most recent cross-reference analysis, 205 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 48 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 48 drugs.

Below, you will find 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 downloadable Excel document analyzing the information provided for each of the 48 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 SEPTEMBER 28, 2022
    • CPIC Guidelines Only (94 Drugs)
      CPIC Guidelines and FDA Table (48 Drugs) *
      FDA Table Only (63 Drugs)
      1. Aceclofenac
      2. Alfentanil
      3. Amikacin
      4. Aminosalicylic acid
      5. Aspirin
      6. Atazanavir
      7. Buprenorphine
      8. Chloramphenicol
      9. Chloroquine
      10. Chlorpropamide
      11. Ciprofloxacin
      12. Dabrafenib
      13. Dapsone
      14. Desflurane
      15. Diclofenac
      16. Dimercaprol
      17. Doxorubicin
      18. Enflurane
      19. Fentanyl
      20. Fluvastatin
      21. Furazolidone
      22. Gentamicin
      23. Gliclazide
      24. Glimepiride
      25. Glipizide
      26. Glyburide
      27. Halothane
      28. Hydrocodone
      29. Hydromorphone
      30. Hydroxychloroquine
      31. Indomethacin
      32. Isoflurane
      33. Ivacaftor
      34. Kanamycin
      35. Levomethadone
      36. Lornoxicam
      37. Lovastatin
      38. Lumiracoxib
      39. Mafenide
      40. Mepacrine
      41. Mesalazine
      42. Metamizole
      43. Methadone
      44. Methoxyflurane
      45. Methylene blue
      46. Morphine
      47. Moxifloxacin
      48. Nabumetone
      49. Nalidixic acid
      50. Naltrexone
      51. Naproxen
      52. Nicorandil
      53. Nitrofural
      54. Nitrofurantoin
      55. Norfloxacin
      56. Ofloxacin
      57. Ondansetron
      58. Oxycodone
      59. Paromomycin
      60. Peginterferon alfa-2a
      61. Peginterferon alfa-2b
      62. Pegloticase
      63. Phenazopyridine
      64. Pitavastatin
      65. Plazomicin
      66. Pravastatin
      67. Primaquine
      68. Probenecid
      69. Quinine
      70. Rasburicase
      71. Remifentanil
      72. Ribavirin
      73. Sertraline
      74. Sevoflurane
      75. Sodium nitrite
      76. Streptomycin
      77. Sufentanil
      78. Sulfacetamide
      79. Sulfadiazine
      80. Sulfadimidine
      81. Sulfanilamide
      82. Sulfisoxazole
      83. Tafenoquine
      84. Tegafur
      85. Tenoxicam
      86. Tobramycin
      87. Tolazamide
      88. Tolbutamide
      89. Toluidine blue
      90. Trametinib
      91. Trimipramine
      92. Tropisetron
      93. Vitamin C
      94. Vitamin K
      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. Esomeprazole
      20. Fluorouracil
      21. Flurbiprofen
      22. Fluvoxamine
      23. Fosphenytoin
      24. Ibuprofen
      25. Imipramine
      26. Lansoprazole
      27. Meloxicam
      28. Mercaptopurine
      29. Nortriptyline
      30. Omeprazole
      31. Oxcarbazepine
      32. Pantoprazole
      33. Paroxetine
      34. Phenytoin
      35. Piroxicam
      36. Rabeprazole
      37. Rosuvastatin
      38. Simvastatin
      39. Succinylcholine
      40. Sulfamethoxazole/Trimethoprim
      41. Sulfasalazine
      42. Tacrolimus
      43. Tamoxifen
      44. Thioguanine
      45. Tramadol **
      46. Trimipramine
      47. Voriconazole
      48. 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. Fesoterodine
      27. Flibanserin
      28. Galantamine
      29. Gefitinib
      30. Hydralazine
      31. Iloperidone
      32. Irinotecan
      33. Isoniazid
      34. Lapatinib
      35. Lofexidine
      36. Meclizine
      37. Metoclopramide
      38. Metoprolol
      39. Mirabegron
      40. Mivacurium
      41. Nebivolol
      42. Nilotinib
      43. Oliceridine
      44. Pazopanib
      45. Perphenazine
      46. Pimozide
      47. Pitolisant
      48. Procainamide
      49. Propafenone
      50. Propranolol
      51. Protriptyline
      52. Raltegravir
      53. Risperidone
      54. Sacituzumab
      55. Siponimod
      56. Tamsulosin
      57. Tetrabenazine
      58. Thioridazine
      59. Tolterodine
      60. Valbenazine
      61. Venlafaxine
      62. Viloxazine
      63. Vortioxetine 

      Abbreviations: CPIC (Clinical Pharmacogenetics Implementation Consortium); FDA (Food and Drug Administration); PK (pharmacokinetics).
      * Reflects CPIC provisional levels.
      ** Carbamazepine, codeine, and tramadol are listed in two FDA sections for different gene-drug associations.

  • WHERE DRUGS NAMED BY FDA AND CPIC APPEAR: AS OF SEPTEMBER 28, 2022
    • Drugs Included in FDA's Table of Pharmacogenetic Associations and CPIC Clinical Guidelines: As of September 28, 2022


  • CHANGE LOG: JULY 8, 2022 - SEPTEMBER 28, 2022
    • DrugFrom:
      To:
      Tramadol
      CPIC's guidelines and FDA's table.Updated/additional entry in CPIC's guidelines and FDA's table under "Potential Impact on Safety/Response."
      Esomeprazole 
      FDA's table only.
      CPIC's guidelines and FDA's table.
      Rabeprazole 
      FDA's table only.CPIC's guidelines and FDA's table.
      Sulfamethoxazole/trimethoprim
      FDA's table only.
      CPIC's guidelines and FDA's table.
      Sulfasalazine
      FDA's table only.CPIC's guidelines and FDA's table.
      Aceclofenac
      Not listed by either source.
      CPIC's guidelines only.
      Alfentanil
      Not listed by either source.CPIC's guidelines only.
      Aminosalicylic acidNot listed by either source.
      CPIC's guidelines only.
      Aspirin
      Not listed by either source.CPIC's guidelines only.
      Buprenorphine
      Not listed by either source.
      CPIC's guidelines only.
      Chloramphenicol
      Not listed by either source.CPIC's guidelines only.
      Chloroquine
      Not listed by either source.
      CPIC's guidelines only.
      ChlorpropamideNot listed by either source.CPIC's guidelines only.
      CiprofloxacinNot listed by either source.
      CPIC's guidelines only.
      DabrafenibNot listed by either source.CPIC's guidelines only.
      DapsoneNot listed by either source.
      CPIC's guidelines only.
      DicolfenacNot listed by either source.CPIC's guidelines only.
      DimercaprolNot listed by either source.
      CPIC's guidelines only.
      DoxorubicinNot listed by either source.CPIC's guidelines only.
      FentanylNot listed by either source.
      CPIC's guidelines only.
      FurazolidoneNot listed by either source.CPIC's guidelines only.
      Gliclazide
      Not listed by either source.
      CPIC's guidelines only.
      GlimepirideNot listed by either source.CPIC's guidelines only.
      Glipizide
      Not listed by either source.
      CPIC's guidelines only.
      GlyburideNot listed by either source.CPIC's guidelines only.
      HydromorphoneNot listed by either source.
      CPIC's guidelines only.
      HydroxychloroquineNot listed by either source.CPIC's guidelines only.
      IndomethacinNot listed by either source.
      CPIC's guidelines only.
      LevomethadoneNot listed by either source.CPIC's guidelines only.
      LumiracoxibNot listed by either source.
      CPIC's guidelines only.
      MafenideNot listed by either source.CPIC's guidelines only.
      MepacrineNot listed by either source.
      CPIC's guidelines only.
      MesalazineNot listed by either source.CPIC's guidelines only.
      MetamizoleNot listed by either source.
      CPIC's guidelines only.
      MethadoneNot listed by either source.CPIC's guidelines only.
      Methylene blueNot listed by either source.
      CPIC's guidelines only.
      MorphineNot listed by either source.CPIC's guidelines only.
      MoxifloxacinNot listed by either source.
      CPIC's guidelines only.
      NabumetoneNot listed by either source.CPIC's guidelines only.
      Nalidixic acidNot listed by either source.
      CPIC's guidelines only.
      NaltrexoneNot listed by either source.CPIC's guidelines only.
      NaproxenNot listed by either source.
      CPIC's guidelines only.
      NicorandilNot listed by either source.CPIC's guidelines only.
      NitrofuralNot listed by either source.
      CPIC's guidelines only.
      NitrofurantoinNot listed by either source.CPIC's guidelines only.
      NorfloxacinNot listed by either source.
      CPIC's guidelines only.
      OfloxacinNot listed by either source.CPIC's guidelines only.
      OxycodoneNot listed by either source.
      CPIC's guidelines only.
      PegloticaseNot listed by either source.CPIC's guidelines only.
      PhenazopyridineNot listed by either source.
      CPIC's guidelines only.
      PrimaquineNot listed by either source.CPIC's guidelines only.
      ProbenecidNot listed by either source.
      CPIC's guidelines only.
      QuinineNot listed by either source.CPIC's guidelines only.
      RasburicaseNot listed by either source.
      CPIC's guidelines only.
      RemifentanilNot listed by either source.CPIC's guidelines only.
      RibavirinNot listed by either source.
      CPIC's guidelines only.
      Sodium nitriteNot listed by either source.CPIC's guidelines only.
      SufentanilNot listed by either source.
      CPIC's guidelines only.
      SulfacetamideNot listed by either source.CPIC's guidelines only.
      SulfadiazineNot listed by either source.
      CPIC's guidelines only.
      SulfadimidineNot listed by either source.CPIC's guidelines only.
      SulfanilamideNot listed by either source.
      CPIC's guidelines only.
      SulfisoxazoleNot listed by either source.CPIC's guidelines only.
      TafenoquineNot listed by either source.
      CPIC's guidelines only.
      TegafurNot listed by either source.CPIC's guidelines only.
      TolazamideNot listed by either source.
      CPIC's guidelines only.
      TolbutamideNot listed by either source.CPIC's guidelines only.
      Toluidine blueNot listed by either source.
      CPIC's guidelines only.
      TrametinibNot listed by either source.CPIC's guidelines only.
      Vitamin CNot listed by either source.
      CPIC's guidelines only.
      Vitamin KNot listed by either source.CPIC's guidelines only.
  • 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