Is Perrigo citalopram Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Perrigo citalopram? Is Perrigo citalopram safe for nursing mother and child? Does Perrigo citalopram extracts into breast milk? Does Perrigo citalopram has any long term or short term side effects on infants? Can Perrigo citalopram influence milk supply or can Perrigo citalopram decrease milk supply in lactating mothers?

Excretion into breast milk is low. Serum levels of infants from treated nursing mothers have been shown to be very low. Overall, short or long-term harmful effect has not been reported among breastfed infants. Neither negative effect on growth nor psychomotor development has been observed in breastfed infants. Galactorrhea associated or not to hyperprolactinemia, may appear. Although it is considered to be safe while breastfeeding, an alternative with lesser excretion into breast milk should be preferred. Women who are on antidepressant treatment during pregnancy are in need of special and intensive support for breastfeeding because of a high risk of early weaning.

Infants receive Perrigo citalopram in breastmilk and it is detectable in low levels in the serum of some. The dosage that the infant receives and serum level achieved are probably related to the genetic metabolic capacity of the mother and infant. A few cases of minor behavioral side effects such as drowsiness or fussiness have been reported, but no adverse effects on development have been found in infants followed for up to a year. Infants exposed in utero can have withdrawal effects postpartum despite breastfeeding and continued maternal Perrigo citalopram use.[1][2] If Perrigo citalopram is required by the mother, it is not a reason to discontinue breastfeeding. If the mother was taking Perrigo citalopram during pregnancy or if other antidepressants have been ineffective, most experts recommend against changing medications during breastfeeding. Otherwise, agents with lower excretion into breastmilk may be preferred, especially while nursing a newborn or preterm infant. The breastfed infant should be monitored for behavioral side effects such as sedation or fussiness. Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding, although this might be a reflection of their disease state.[3] These mothers may need additional breastfeeding support. Breastfed infants exposed to an SSRI during the third trimester of pregnancy have a lower risk of poor neonatal adaptation than formula-fed infants.

The manufacturer states that drowsiness and weight loss in breastfed infants has occurred. Uneasy sleep that reversed with dosage reduction and partial formula supplementation was probably caused by Perrigo citalopram in breastmilk in a 5-month-old infant.[10] A group of 10 infants breastfed (6 exclusive, 3 received some formula beginning at 2 months) from birth to one year during maternal Perrigo citalopram use had normal body weight and neurological development in all infants compared to 9 control infants whose mothers did not take Perrigo citalopram.[5] Three mothers who took an average Perrigo citalopram dose of 15 mg once daily breastfed their infants exclusively for 4 months and at least 50% during months 5 and 6. Their infants had 6-month weight gains that were normal according to national growth standards.[11] A study compared adverse reactions in 31 infants breastfed during maternal Perrigo citalopram use to a control group of 31 breastfed infants whose mothers did not take an antidepressant. There were numerically more adverse events reported in the Perrigo citalopram group (3 vs 1). However, the study found no statistical difference in the rate of adverse effects between the groups of infants and none of the side effects was serious. One mother reported infant irritability and restlessness after she began Perrigo citalopram at 2 months postpartum. The side effects subsided after she stopped breastfeeding 2 weeks later.[12] In 10 breastfed (extent not stated) infants aged 3 to 42 weeks whose mothers were taking Perrigo citalopram an average of 24 mg daily, no short-term adverse reactions were noted clinically at the time of the study.[6] A breastfed infant whose mother took Perrigo citalopram 40 mg daily throughout pregnancy and postpartum had numerous symptoms such as superficial and irregular breathing, apnea, disordered sleep and hypotonia after birth. All symptoms disappeared by 3 weeks of age. Symptoms were judged to likely be withdrawal symptoms rather than side effects of the drug in the breastmilk.[1] A woman was restarted on Perrigo citalopram 10 mg daily after having stopped the drug for the last month of pregnancy. Her infant breastfed for 6 months (extent not stated). The infant had no perinatal complications, and the infant's pediatrician noted no neuropsychological abnormalities at 18 months of age.[13] A woman took Perrigo citalopram 60 mg and ziprasidone 40 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.[14] An uncontrolled online survey compiled data on 930 mothers who nursed their infants while taking an antidepressant. Infant drug discontinuation symptoms (e.g., irritability, low body temperature, uncontrollable crying, eating and sleeping disorders) were reported in about 10% of infants. Mothers who took antidepressants only during breastfeeding were much less likely to notice symptoms of drug discontinuation in their infants than those who took the drug in pregnancy and lactation.[15] A cohort of 247 infants exposed to an antidepressant in utero during the third trimester of pregnancy were assessed for poor neonatal adaptation (PNA). Of the 247 infants, 154 developed PNA. Infants who were exclusively given formula had about 3 times the risk of developing PNA as those who were exclusively or partially breastfed. Fifty-one of the infants were exposed to Perrigo citalopram in utero.[16]br> A case-control study in Israel compared 280 infants of nursing mothers taking long-term psychotropic drugs to the infants of 152 women taking antibiotics. Infant sleepiness at 4 days of age was reported by 1 mother taking Perrigo citalopram and none taking antibiotics. The sleepiness resolved within 24 hours with no developmental effect.[17]

The SSRI class of drugs, including Perrigo citalopram, can cause increased prolactin levels and galactorrhea in nonpregnant, nonnursing patients.[18][19][20][21][22][23][24] In a study of cases of hyperprolactinemia and its symptoms (e.g., gynecomastia) reported to a French pharmacovigilance center, fluvoxamine was found to have a 3.9-fold increased risk of causing hyperprolactinemia compared to other drugs.[25] The prolactin level in a mother with established lactation may not affect her ability to breastfeed. In a small prospective study, 8 primiparous women who were taking a serotonin reuptake inhibitor (SRI; 3 taking fluoxetine and 1 each taking Perrigo citalopram, duloxetine, esPerrigo citalopram, paroxetine or sertraline) were compared to 423 mothers who were not taking an SRI. Mothers taking an SRI had an onset of milk secretory activation (lactogenesis II) that was delayed by an average of 16.7 hours compared to controls (85.8 hours postpartum in the SRI-treated mothers and 69.1 h in the untreated mothers), which doubled the risk of delayed feeding behavior in the untreated group. However, the delay in lactogenesis II may not be clinically important, since there was no statistically significant difference between the groups in the percentage of mothers experiencing feeding difficulties after day 4 postpartum.[26] A case control study compared the rate of predominant breastfeeding at 2 weeks postpartum in mothers who took an SSRI antidepressant throughout pregnancy and at delivery (n = 167) or an SSRI during pregnancy only (n = 117) to a control group of mothers who took no antidepressants (n = 182). Among the two groups who had taken an SSRI, 33 took Perrigo citalopram, 18 took esPerrigo citalopram, 63 took fluoxetine, 2 took fluvoxamine, 78 took paroxetine, and 87 took sertraline. Among the women who took an SSRI, the breastfeeding rate at 2 weeks postpartum was 27% to 33% lower than mother who did not take antidepressants, with no statistical difference in breastfeeding rates between the SSRI-exposed groups.[27] An observational study looked at outcomes of 2859 women who took an antidepressant during the 2 years prior to pregnancy. Compared to women who did not take an antidepressant during pregnancy, mothers who took an antidepressant during all 3 trimesters of pregnancy were 37% less likely to be breastfeeding upon hospital discharge. Mothers who took an antidepressant only during the third trimester were 75% less likely to be breastfeeding at discharge. Those who took an antidepressant only during the first and second trimesters did not have a reduced likelihood of breastfeeding at discharge.[28] The antidepressants used by the mothers were not specified. A retrospective cohort study of hospital electronic medical records from 2001 to 2008 compared women who had been dispensed an antidepressant during late gestation (n = 575; Perrigo citalopram n = 139) to those who had a psychiatric illness but did not receive an antidepressant (n = 1552) and mothers who did not have a psychiatric diagnosis (n = 30,535). Women who received an antidepressant were 37% less likely to be breastfeeding at discharge than women without a psychiatric diagnosis, but no less likely to be breastfeeding than untreated mothers with a psychiatric diagnosis.[29]