Fluvoxamine Pregnancy and Breastfeeding Warnings
Fluvoxamine Pregnancy Warnings
Fluvoxamine has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity. One study compared 267 women exposed to a selective serotonin reuptake inhibitor (SSRI), either fluvoxamine, paroxetine, or sertraline, to 267 controls. Exposure to SSRIs was not reported to be associated with either increased risk for major malformations, higher rates of miscarriage, stillbirth, or prematurity. Mean birth weights among SSRI users were similar to controls as were the gestational ages. The study concluded that the SSRIs fluvoxamine, paroxetine, and sertraline did not appear to increase teratogenic risk when used in their recommended doses. Fluvoxamine should only be given during pregnancy when benefit outweighs risk.
Fluvoxamine Breastfeeding Warnings
Fluvoxamine is excreted into human milk. No adverse effects in nursing infants have been reported. Fluvoxamine is described by the American Academy of Pediatrics as a drug whose "effect on nursing infants is unknown but may be of concern".
Upon entering the breast milk compartment, a large proportion of fluvoxamine has been reported to become ionized and therefore trapped. Two reports from lactating woman taking fluvoxamine have described milk fluvoxamine concentrations to be about one-third serum concentrations. A third report from a lactating women had various levels depending on when the samples were taken. Fluvoxamine breast milk levels were reported to be highest four hours after receiving a dose and lowest just before the next dose was taken. Three infants breast-fed by mothers who were taking fluvoxamine have been reported in the literature. Two were reported to have had an estimated dose of fluvoxamine equal to 0.50% of the maternal dose while the third infant was reported to have had an estimated dose of fluvoxamine that was 0.62% of the maternal dose. The third infant was reported to have an actual serum level of fluvoxamine that was 45% of the maternal serum level. It was theorized that the difference in levels may have been due to this infant's hepatic cytochrome P450 enzyme system. Because this infant's rate of metabolism for fluvoxamine may be atypical, more studies of fluvoxamine levels in breast-fed infants are needed before any conclusions can be drawn. The clinical relevance of this is also uncertain because what level of fluvoxamine constitutes a significant exposure in a nursing infant has yet to be determined.
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