Flixotide Use In Pregnancy & Lactation

Effects on Fertility: There are no data on human fertility. No effects of FLIXOTIDE on male or female fertility were observed in rats at subcutaneous doses up to 50 μg/kg/day.
Use in Pregnancy: There are limited data in pregnant women. Administration of FLIXOTIDE during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
An observational retrospective epidemiological cohort study utilising electronic health records from the United Kingdom was conducted to evaluate the risk of major congenital malformations (MCMs) following first trimester exposure to inhaled fluticasone propionate alone and salmeterol-fluticasone propionate combination relative to non-fluticasone propionate containing inhaled corticosteroids. No placebo comparator was included in this study.
Within the asthma cohort of 5,362 first trimester inhaled corticosteroid-exposed pregnancies, 131 diagnosed MCMs were identified: 1,612 (30%) were exposed to fluticasone propionate or salmeterol-fluticasone propionate of which 42 diagnosed MCMs were identified. The adjusted odds ratio for MCMs diagnosed by 1 year was 1.1 (95%CI: 0.5 - 2.3) for fluticasone propionate exposed vs non-fluticasone propionate inhaled corticosteroid exposed women with moderate asthma and 1.2 (95%: 0.7 - 2.0) for women with considerable to severe asthma. No difference in the risk of MCMs was identified following first trimester exposure to fluticasone propionate alone versus salmeterol-fluticasone propionate combination. Absolute risks of MCM across the asthma severity strata ranged from 2.0 to 2.9 per 100 fluticasone propionate-exposed pregnancies which is comparable to results from a study of 15,840 pregnancies unexposed to asthma therapies in the General Practice Research Database (2.8 MCM events per 100 pregnancies).
Results from the retrospective epidemiological study did not find an increased risk of MCMs following exposure to fluticasone propionate when compared to other inhaled corticosteroids, during the first trimester of pregnancy.
Corticosteroids are known to induce fetotoxic and teratogenic effects in rodent studies. However, equivalent effects have not been reported when these compounds have been given to humans during pregnancy. Teratology studies with fluticasone propionate in mice and rats have shown the expected fetotoxic and teratogenic effects at SC doses of 100 to 150 micrograms/kg/day and above. In an inhalational teratology study in rats, fluticasone propionate was not teratogenic at inhalational doses up to 68.7 micrograms/kg/day, but reduced fetal bodyweight and delayed fetal development were noted at maternal doses of 25.7 micrograms/kg/day and greater. Mean fetal weight, retardation of ossification, and decreased postnatal viability were observed in rats receiving fluticasone propionate at 50 micrograms/kg/day SC. As for previous compounds of this class, these effects are unlikely to be relevant to human therapy.
Use in Lactation: The excretion of fluticasone propionate into human breast milk has not been investigated. Subcutaneous administration of titrated drug to lactating rats resulted in measurable radioactivity in both plasma and milk (levels in milk were 3-7 times plasma levels) 1-8 hours post-dose.
However, the amount of fluticasone propionate ingested by the newborn is estimated to be very small as a consequence of very low maternal plasma concentration of fluticasone propionate.
Administration during lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the child.