Fluphenazine Pregnancy and Breastfeeding Warnings
Fluphenazine Pregnancy Warnings
Fluphenazine has not been formally assigned to a pregnancy category by the FDA. Fluphenazine has been assigned to pregnancy Risk Factor C by Briggs et al. One case of multiple congenital abnormalities has been reported in an infant whose mother took fluphenazine enanthate and other drugs during pregnancy. The anomalies reported include metopic suture, telecanthus, ocular hypertelorism, nystagmoid eye movements, bilateral cleft lip and palate, imperforate anus, rectourethral fistula, bifid scrotum and hypospadias. Another case has been reported where a woman on fluphenazine had a baby with gastroesophageal reflux and left hydronephrosis due to uretero pelvic junction obstruction. Two years later at 38 weeks gestation that same woman (still on fluphenazine) gave birth to a healthy baby. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Fluphenazine should be given during pregnancy only when benefit outweighs risk.
Fluphenazine Breastfeeding Warnings
There are no data on the excretion of fluphenazine into human milk.
References for pregnancy information
- Cleary MF "Fluphenazine decanoate during pregnancy." Am J Psychiatry 134 (1977): 815-6
- Donaldson GL, Bury RG "Multiple congenital abnormalities in a newborn boy associated with maternal use of fluphenazine enanthate and other drugs during pregnancy." Acta Paediatr Scand 71 (1982): 335-8
- Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 7th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2005):
- Merlob P, Stahl B, Maltz E "Is fluphenazine a teratogen?" Am J Med Genet 52 (1994): 231-2
References for breastfeeding information
- "Product Information. Prolixin (fluphenazine)." Bristol-Myers Squibb, Princeton, NJ.
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