Table 6.
Adverse events of pyrimethamine-based therapies for congenital toxoplasmosis
| Study (first author, year) | PYR-based treatment | Total AEs | Discontinuation/change of treatment | Hematologic | Gastrointestinal | Dermatologic | Other | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neutropenia | Thrombocytopenia | Anemia | Eosinophilia | Nausea and/or vomiting | Diarrhea | Intolerance | Rash | |||||
| Randomized studies | ||||||||||||
| McLeod (2006) [47] | TX-A: PS 2 months TX-B: PS 6 months |
– | TX-A: 21/57 (37%) TX-B 20/59 (34%) |
21/57 (37%) | – | – | – | – | – | – | – | – |
| 20/59 (34%) | – | – | – | – | – | – | – | – | ||||
| Observational studies | ||||||||||||
| Faucher (2012) [51] | PYR + SDX | 10/121 (8.3%) | 5/121 (4.1%) | 2/121 (1.7%) | – | 1/121 (0.8%) | – | 1/121 (0.8%) | – | – | 1/121 (0.8%) | – |
| Guerina (1994) [48] | PYR + SDZ | 15/47 (31.9%) | 4/52 (7.7%) | 7/47 (14.9%) | – | 6/47 (14.9%) | – | – | – | – | 1/47 (2.1%) | – |
| Hohlfeld (1989) [52] | Maternal PYR + SDX | 5/43 (11.6%) | – | – | – | Maternal 4/43 (9.3%) | – | – | – | Maternal 1/43 (2.3%) | – | – |
| Infants PYR + sulfonamides | 2/54 (3.7%) | – | – | – | Infant 1/54 (1.9%) | – | – | – | – | – | Allergic reaction 1/54 (1.9%) | |
| Lipka (2011) [49] | PS and PYR + SDX | 11/24 (45.8%) | 12/24 (50%) | 11/24 (45.8%) | – | – | – | – | – | – | – | – |
| Mombro (1995) [53] | PYR + SMP | 3/6 (50%) | 3/6 (50%) | – | – | 3/6 (50%) | – | – | – | – | – | – |
| Schmidt (2006) [67] | PS | 7/48 (14.6%) | 7/48 (14.6%) | 6/48 (12.5%) | – | – | – | – | – | – | – | Elevated bilirubin 1/48 (2.0%) |
| Stray-Pedersen (1980) [68] | PS | 0/52 (0%) | – | – | – | – | – | – | – | – | – | – |
| Hotop (2012) [56] | PS | Maternal 25/119 (21.0%) Infant 0/33 (0%) |
– | – | – | – | – | Maternal 25/119 (21%) | – | – | – | Maternal Hypersensitivity reaction 1/119 (0.8%) |
| Villena (1998) [55] | PYR + SDX | 1/78 (1.3%) | – | – | – | – | – | – | – | – | 1/78 (1.3%) | – |
| Teil (2016) [58] | PYR + SDZ PYR + SDX |
16/65 (24.6%) (none were attributed to TX) 37/65 (36.9%) hematologic AEs |
7/65 (10.8%) | 21/65 (32.3%) | 5/65 (7.7%) | 14/65 (21.5%) | 17/65 (26.2%) | 7/65 (10.8%) | 4/65 (6.2%) | – | 1/65 (1.5%) | Agitation 4/65 (6.2%) Erythema 1/65 (1.5%) |
| Capobiango (2014) [59] | PS | 16/29 (55.2%) | – | 13/29 (44/8%) | 2/29 (6.9%) | 2/29 (6.9%) | – | – | – | – | – | Hepatitis 4/29 (13.8%) |
| Carellos (2017) [57] | – | – | 3/171 (1.8%) | 65/171 (37%) | 12/171 (7.0%) | 28/171 (16.4%) | – | – | – | 3/171 (1.8%) | – | Multiple blood disorder 9.4% |
Unless otherwise specified, values refer to infant/children
AEs adverse events, PS pyrimethamine plus sulfadiazine, PYR pyrimethamine, SDX sulfadoxine, SDZ sulfadiazine, SMP sulphamethopyrazine, TX treatment