Recommendations for antifungal use in pregnancy
| Antifungal . | FDA pregnancy category* . | Placental transfer . | Animal data . | Clinical data . |
|---|---|---|---|---|
| Amphotericin (AmBisome) | B | Yes | No teratogenic harmIn high dose, SA | Much successful data; transient neonatal renal dysfunction if given in the third trimester (safety unclear) |
| Caspofungin | C | Yes | Skeletal abnormalities | Avoid in pregnancy in the first trimester. |
| Fluconazole | D (C if single 150 mg dose) | LMW makes passage likely | Skeletal and cardiac malformations for long-term high-dose use | Skeletal and cardiac malformations for long-term high-dose use; avoid in pregnancy |
| Itraconazole | C | LMW makes passage likely | Major skeletal defects, encephaloceles, macroglossia | Risk of structural anomalies (skeletal, cardiac, renal) is low; increase in SA. Avoid in pregnancy unless benefit outweighs risk |
| Posaconazole | C | LMW makes passage likely | No data. Avoid in pregnancy unless benefit outweighs risk | |
| Voriconazole | D | LMW makes passage likely | Strongly associated with teratogenicity: cleft palate, hydronephrosis, bone abnormalities | Avoid in pregnancy unless benefit outweighs risk |
| Antifungal . | FDA pregnancy category* . | Placental transfer . | Animal data . | Clinical data . |
|---|---|---|---|---|
| Amphotericin (AmBisome) | B | Yes | No teratogenic harmIn high dose, SA | Much successful data; transient neonatal renal dysfunction if given in the third trimester (safety unclear) |
| Caspofungin | C | Yes | Skeletal abnormalities | Avoid in pregnancy in the first trimester. |
| Fluconazole | D (C if single 150 mg dose) | LMW makes passage likely | Skeletal and cardiac malformations for long-term high-dose use | Skeletal and cardiac malformations for long-term high-dose use; avoid in pregnancy |
| Itraconazole | C | LMW makes passage likely | Major skeletal defects, encephaloceles, macroglossia | Risk of structural anomalies (skeletal, cardiac, renal) is low; increase in SA. Avoid in pregnancy unless benefit outweighs risk |
| Posaconazole | C | LMW makes passage likely | No data. Avoid in pregnancy unless benefit outweighs risk | |
| Voriconazole | D | LMW makes passage likely | Strongly associated with teratogenicity: cleft palate, hydronephrosis, bone abnormalities | Avoid in pregnancy unless benefit outweighs risk |
LMW, low molecular weight. Other abbreviations are explained in Table 1.
FDA pregnancy categories: (Category A) Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). (Category B) Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. (Category C) Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. (Category D) There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.52