Table 1.

New signals of DIIHA identified in Vigibase

Suspected drugsNumber of cases recorded in VigibaseROR95% CIMarketed in France between 2012 and 2018Exposure measurable in out-of-hospital data of the SNDS database
Class A: alimentary tract and metabolism 
Mesalazine 8 2.9 1.5-5.9 Yes Yes 
Glibenclamide 14 6.1 3.6-10.3 Yes Yes 
Repaglinide 5 9.3 3.9-22.5 Yes Yes 
Imiglucerase 3 6.5 2.1-20.2 Yes No 
Laronidase 4 17.8 6.7-47.6 Yes No 
Class B: blood and blood-producing organs 
Romiplostim 30 19.6 13.7-28.1 Yes Yes 
Eltrombopag 15 8.5 5.1-14.1 Yes Yes 
Class C: cardiovascular system 
Tocainide 3 13.1 4.2-40.8 No - 
Urapidil 3 11.2 3.6-35.0 Yes Yes 
Amiloride 7 4.7 2.2-9.9 Yes Yes 
Chlorothiazide 3 21.7 7.0-67.5 No - 
Lercanidipine 4 4.9 1.85-13.2 Yes Yes 
Lovastatin 6 2.3 1.0-5.0 No - 
Class G: genito-urinary system and sex hormones 
Danazol 4 7.6 2.9-20.3 Yes Yes 
Serenoa repens 3 21.1 6.8-65.6 Yes Yes 
Class J: anti-infective for systemic use 
Flucloxacillin 6 3.8 1.7-8.5 No — 
Cefpodoxime 5 5.0 2.1-12.0 Yes Yes 
Cefepime 7 4.0 1.9-8.5 Yes Yes 
Sulfamethoxazole and trimethoprim∗  8 5.3 2.7-10.7 Yes Yes 
Indinavir 4 3.4 1.3-9.0 Yes Yes 
Zidovudine†  13 1.9 1.1-3.2 Yes Yes 
Entecavir 5 6.5 2.7-15.6 Yes Yes 
Ribavirin 41 2.8 2.1-3.9 Yes Yes 
Anti-D immunoglobulin 11 32.7 18.1-59.3 Yes No 
Normal human immunoglobulin 109 11.6 9.7-14.2 Yes No 
Class L: antineoplastics and immunomodulating agents 
Chlorambucil 5 14.3 6.0-34.6 Yes Yes 
Cyclophosphamide‡  85 5.8 4.7-7.2 Yes Yes 
Busulfan‡  13 15.9 9.2-27.5 Yes Yes 
Thiotepa 4 11.1 4.2-29.8 Yes No 
Azacitidine‡  5 3.0 1.3-7.3 Yes Yes 
Etoposide‡  13 2.2 1.3-3.8 Yes Yes 
Ibrutinib 63 12.8 10.0-16.5 Yes Yes 
Idelalisib 5 5.5 2.3-13.2 Yes Yes 
Ofatumumab 4 16.3 6.1-43.7 Yes No 
Nivolumab 82 12.9 10.4-16.1 Yes No 
Pembrolizumab 35 10.3 7.4-14.4 Yes No 
Ipilimumab 26 8.9 6.1-13.2 Yes No 
Atezolizumab 6 7.8 3.5-17.4 Yes No 
Hydroxycarbamide 4 3.5 1.3-9.4 Yes Yes 
Venetoclax 32 23.2 16.4-33.0 Yes Yes 
Pentostatin 10 90.2 48.3-168.6 Yes No 
Mycophenolate 40 5.7 4.1-7.7 Yes Yes 
Sirolimus 7 4.7 2.2-9.8 Yes Yes 
Fingolimod 22 1.8 1.2-2.7 Yes Yes 
Azathioprine 27 6.6 4.5-9.6 Yes Yes 
Antithymocyte immunoglobulin 38 27.9 20.3-38.5 Yes No 
Vedolizumab 8 2.9 1.5-5.8 Yes No 
Basiliximab 6 14.7 6.6-32.9 Yes No 
Eculizumab 19 3.1 2.0-4.9 Yes No 
Daclizumab 15 21.9 13.2-36.5 No — 
Efalizumab 8 16.9 8.5-33.9 No — 
Class M: musculo-skeletal system 
Meclofenamic acid 6 77.7 34.7-174.0 No — 
Penicillamine 4 7.2 2.7-19.3 Yes Yes 
Allopurinol 20 3.8 2.4-5.9 Yes Yes 
Class N: nervous system 
Carbidopa and levodopa§  21 4.1 2.7-6.3 Yes Yes 
Benserazide and levodopa §  16 17.4 10.7-28.6 Yes Yes 
Entacapone and levodopa§  5 6.9 2.9-16.5 Yes Yes 
Apomorphine 15 14.3 8.6-23.8 Yes Yes 
Class V: various 
Deferasirox 13 3.8 2.2-6.5 Yes Yes 
Suspected drugsNumber of cases recorded in VigibaseROR95% CIMarketed in France between 2012 and 2018Exposure measurable in out-of-hospital data of the SNDS database
Class A: alimentary tract and metabolism 
Mesalazine 8 2.9 1.5-5.9 Yes Yes 
Glibenclamide 14 6.1 3.6-10.3 Yes Yes 
Repaglinide 5 9.3 3.9-22.5 Yes Yes 
Imiglucerase 3 6.5 2.1-20.2 Yes No 
Laronidase 4 17.8 6.7-47.6 Yes No 
Class B: blood and blood-producing organs 
Romiplostim 30 19.6 13.7-28.1 Yes Yes 
Eltrombopag 15 8.5 5.1-14.1 Yes Yes 
Class C: cardiovascular system 
Tocainide 3 13.1 4.2-40.8 No - 
Urapidil 3 11.2 3.6-35.0 Yes Yes 
Amiloride 7 4.7 2.2-9.9 Yes Yes 
Chlorothiazide 3 21.7 7.0-67.5 No - 
Lercanidipine 4 4.9 1.85-13.2 Yes Yes 
Lovastatin 6 2.3 1.0-5.0 No - 
Class G: genito-urinary system and sex hormones 
Danazol 4 7.6 2.9-20.3 Yes Yes 
Serenoa repens 3 21.1 6.8-65.6 Yes Yes 
Class J: anti-infective for systemic use 
Flucloxacillin 6 3.8 1.7-8.5 No — 
Cefpodoxime 5 5.0 2.1-12.0 Yes Yes 
Cefepime 7 4.0 1.9-8.5 Yes Yes 
Sulfamethoxazole and trimethoprim∗  8 5.3 2.7-10.7 Yes Yes 
Indinavir 4 3.4 1.3-9.0 Yes Yes 
Zidovudine†  13 1.9 1.1-3.2 Yes Yes 
Entecavir 5 6.5 2.7-15.6 Yes Yes 
Ribavirin 41 2.8 2.1-3.9 Yes Yes 
Anti-D immunoglobulin 11 32.7 18.1-59.3 Yes No 
Normal human immunoglobulin 109 11.6 9.7-14.2 Yes No 
Class L: antineoplastics and immunomodulating agents 
Chlorambucil 5 14.3 6.0-34.6 Yes Yes 
Cyclophosphamide‡  85 5.8 4.7-7.2 Yes Yes 
Busulfan‡  13 15.9 9.2-27.5 Yes Yes 
Thiotepa 4 11.1 4.2-29.8 Yes No 
Azacitidine‡  5 3.0 1.3-7.3 Yes Yes 
Etoposide‡  13 2.2 1.3-3.8 Yes Yes 
Ibrutinib 63 12.8 10.0-16.5 Yes Yes 
Idelalisib 5 5.5 2.3-13.2 Yes Yes 
Ofatumumab 4 16.3 6.1-43.7 Yes No 
Nivolumab 82 12.9 10.4-16.1 Yes No 
Pembrolizumab 35 10.3 7.4-14.4 Yes No 
Ipilimumab 26 8.9 6.1-13.2 Yes No 
Atezolizumab 6 7.8 3.5-17.4 Yes No 
Hydroxycarbamide 4 3.5 1.3-9.4 Yes Yes 
Venetoclax 32 23.2 16.4-33.0 Yes Yes 
Pentostatin 10 90.2 48.3-168.6 Yes No 
Mycophenolate 40 5.7 4.1-7.7 Yes Yes 
Sirolimus 7 4.7 2.2-9.8 Yes Yes 
Fingolimod 22 1.8 1.2-2.7 Yes Yes 
Azathioprine 27 6.6 4.5-9.6 Yes Yes 
Antithymocyte immunoglobulin 38 27.9 20.3-38.5 Yes No 
Vedolizumab 8 2.9 1.5-5.8 Yes No 
Basiliximab 6 14.7 6.6-32.9 Yes No 
Eculizumab 19 3.1 2.0-4.9 Yes No 
Daclizumab 15 21.9 13.2-36.5 No — 
Efalizumab 8 16.9 8.5-33.9 No — 
Class M: musculo-skeletal system 
Meclofenamic acid 6 77.7 34.7-174.0 No — 
Penicillamine 4 7.2 2.7-19.3 Yes Yes 
Allopurinol 20 3.8 2.4-5.9 Yes Yes 
Class N: nervous system 
Carbidopa and levodopa§  21 4.1 2.7-6.3 Yes Yes 
Benserazide and levodopa §  16 17.4 10.7-28.6 Yes Yes 
Entacapone and levodopa§  5 6.9 2.9-16.5 Yes Yes 
Apomorphine 15 14.3 8.6-23.8 Yes Yes 
Class V: various 
Deferasirox 13 3.8 2.2-6.5 Yes Yes 
∗

Marketed in France only as fixed association: the risk associated with each drug cannot be measured individually.

†

Marketed in France mostly in association with other drugs.

‡

Exposure to these chemotherapy drugs is not measurable in the out-of-hospital data of the SNDS for parenteral route but for the oral route only.

§

Marketed in France only in association with levodopa (listed by Garratty et al5): the risks associated with each drug cannot be measured individually.

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