Table 1.
New signals of DIIHA identified in Vigibase
| Suspected drugs | Number of cases recorded in Vigibase | ROR | 95% CI | Marketed in France between 2012 and 2018 | Exposure 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.