Is Ziprasidone safe while breastfeeding?

Summary of use during breastfeeding

Because there is little published experience with ziprasidone during breastfeeding, other antipsychotic agents may be preferred, especially while nursing a newborn or preterm infant. A safety scoring system finds ziprasidone possible to use cautiously during breastfeeding.[1] Infants breastfed during maternal use of ziprasidone should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms, such as tremors and abnormal muscle movements.

Effects on the breastfed infant

A woman took ziprasidone 40 mg and citalopram 60 mg daily throughout pregnancy and postpartum. She breastfed extensively, except for occasional formula feedings by others. At 6 months of age, a pediatrician found the infant to be healthy with normal growth and development.[3]

Patients enlisted in the National Pregnancy Registry for Atypical Antipsychotics who were taking a second-generation antipsychotic drug while breastfeeding (n = 576) were compared to control breastfeeding patients who were not treated with a second-generation antipsychotic (n = 818). Of the patients who were taking a second-generation antipsychotic drug, 60.4% were on more than one psychotropic. A review of the pediatric medical records, no adverse effects were noted among infants exposed or not exposed to second-generation antipsychotic monotherapy or to polytherapy.[4] The number of women taking ziprasidone was not reported.

Effects on milk supply

Prolactin elevation has occurred during ziprasidone treatment,[5-10] and galactorrhea has been reported, often in adolescents.[7-12] However, prolactin elevation might be more transient and less severe than with phenothiazines.[13-15] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Patients enlisted in the National Pregnancy Registry for Atypical Antipsychotics who were taking a second-generation antipsychotic drug while breastfeeding (n = 576) were compared to control breastfeeding patients who had primarily diagnoses of major depressive disorder and anxiety disorders, most often treated with SSRI or SNRI antidepressants, but not with a second-generation antipsychotic (n = 818). Among women on a second-generation antipsychotic, 60.4% were on more than one psychotropic compared with 24.4% among women in the control group. Of the women on a second-generation antipsychotic, 59.3% reported “ever breastfeeding” compared to 88.2% of women in the control group. At 3 months postpartum, 23% of women on a second-generation antipsychotic were exclusively breastfeeding compared to 47% of women in the control group.[4] The number of women taking ziprasidone was not reported.

Levels in milk

Maternal Levels. In one woman, ziprasidone was started at 9 days postpartum (dosage not stated, but presumably at a low dose and titrated upward). Serum and milk concentrations were obtained 10 minutes before the morning dose every day for 16 days. By day 7 of therapy, the patient was taking 80 mg of ziprasidone twice daily. Ziprasidone was not detectable in milk until day 10 of therapy when the milk concentration was 11 mcg/L; thereafter, the milk concentrations were not quantifiable (<10 mcg/L).[2]

Infant Levels. Relevant published information was not found as of the revision date.

Alternatives LactMed lists

• Haloperidol
• Olanzapine
• Quetiapine
• Risperidone