Elidel (Pimecrolimus) and Pregnancy
Elidel (pimecrolimus) cream is classified as FDA Pregnancy Category C and should only be used during pregnancy if clearly needed, as there are no adequate and well-controlled studies in pregnant women. 1
FDA Classification and Safety Data
Pimecrolimus is FDA Pregnancy Category C, meaning animal studies have shown adverse effects on the fetus, but there are no adequate studies in humans; the drug should be used only if potential benefits justify the potential risk to the fetus. 1
No adequate and well-controlled studies exist in pregnant women, and the experience with Elidel cream when used by pregnant women is too limited to permit assessment of safety during pregnancy. 1
Animal Reproductive Studies
Dermal (Topical) Studies
Dermal embryofetal developmental studies in rats and rabbits showed no maternal or fetal toxicity up to the highest practicable doses tested (10 mg/kg/day in both species, representing 0.14X MRHD in rats and 0.65X MRHD in rabbits based on AUC comparisons). 1
No teratogenicity was observed in dermal studies when pimecrolimus cream was applied topically during organogenesis in rats and rabbits. 1
Oral Studies (Higher Systemic Exposure)
Oral administration studies revealed embryofetal toxicity at high doses: In rats, indicators of embryofetal toxicity (post-implantation loss and reduced litter size) occurred at 45 mg/kg/day (38X MRHD), though no malformations were noted. 1
Maternal toxicity, embryolethality, and fetotoxicity were observed at 45 mg/kg/day in rats (271X MRHD) and 20 mg/kg/day in rabbits (12X MRHD) in oral studies, with slight increases in skeletal variations indicating delayed ossification. 1
Pimecrolimus crosses the placenta in oral rat and rabbit embryofetal developmental studies. 1
Clinical Recommendation
Given the lack of human pregnancy data and the FDA Category C classification, Elidel should be avoided during pregnancy unless the benefit clearly outweighs the risk. 1
Key Considerations:
The topical formulation results in minimal systemic absorption in clinical use, which theoretically reduces fetal exposure compared to oral administration. 2, 3
Pharmacokinetic studies have shown very low blood levels of pimecrolimus following topical application with no accumulation after repeated applications. 3
For atopic dermatitis during pregnancy, consider alternative therapies with better-established safety profiles such as emollients and low-to-medium potency topical corticosteroids, which have more extensive pregnancy safety data. 2