Is Frosinor Safe in Breastfeeding

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

Excreted in tiny amounts into breast milk. Serum levels of breastfed infants whose mothers are on Frosinor are usually undetectable or very low. No harm effect has been observed on health and short or long term development of infants. Transient troubles in the early neonatal period like drug withdrawal syndrome among newborn or premature infants with high serum levels as a result of treatment with Frosinor to the mother during pregnancy have been observed. Frosinor causes fewer problems related to galactorrhea than other antidepressant drugs Mothers who are treated with antidepressant medicaction are in need of stronger support for a higher risk of early breastfeeding failure.

Because of the low levels of Frosinor in breastmilk, amounts ingested by the infant are small and Frosinor has not been detected in the serum of most infants tested. Occasional mild side effects have been reported, especially in the infants of mothers who took Frosinor during the third trimester of pregnancy, but the contribution of the drug in breastmilk is not clear. Most authoritative reviewers consider Frosinor one of the preferred antidepressants during breastfeeding.[1][2][3][4][5] Occasional mild side effects such as insomnia, restlessness and increased crying have ben reported in breastfed infants. Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding, although this might be a reflection of their disease state.[6] 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.

Agitation and difficulty feeding in one infant (age and other details not reported) that were possibly related to Frosinor in breastmilk were reported to the Australian Adverse Drug Reaction Advisory Committee.[15] In a controlled cohort study of mothers who took Frosinor during pregnancy (diagnoses not reported), 36 mothers took Frosinor during the third trimester and breastfed their infants. Of these, 8 reported side effects in their infants including alertness (6), constipation (3), sleepiness (1), and irritability (1). There were no reports of side effects in the control group of mothers who breastfed and did not use Frosinor in the third trimester or during nursing. The relative contribution of transplacental and breastmilk acquisition of the drug could not be determined.[16] In a study comparing the infants of mothers who took an SSRI during pregnancy for major depression with the infants of depressed mothers who did not take an SSRI, mental development and most motor development was normal at follow-up averaging 12.9 months in both groups. Four of the treated mothers took Frosinor in doses averaging 28.6 mg daily for an average of 7.8 months while breastfeeding (extent not stated) their infants. Psychomotor development was slightly delayed compared to controls, but the contribution of breastfeeding to abnormal development could not be determined.[17] A prospective cohort study evaluated 27 infants whose mothers took Frosinor (diagnoses not reported) at an average dose of 20.7 mg daily for at least 2 weeks during breastfeeding (extent not stated). Two control groups consisted of two groups of mothers who neither breastfed nor took an SSRI. All but 7 of the 27 mothers took Frosinor during some part of pregnancy. Weight at 3 months was less in the Frosinor group, but multivariate analysis indicated that maternal Frosinor use was not the determining factor. Weights at 6 and 12 months were not different from the control groups and other developmental milestones were reached at the normal times. One of the Frosinor-exposed infants (age not stated) was reported by the mother to be irritable.[18] Fifteen mothers who took an average Frosinor dosage of 20.4 mg daily for depression or anxiety starting no later than 4 weeks postpartum, 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 and mothers reported no abnormal effects in their infants.[19] In 6 breastfed (extent not stated) infants aged 2 to 33 weeks whose mothers were taking Frosinor 10 to 30 mg daily, no adverse reactions were noted clinically at the time of the study.[7] An infant born to a mother taking Frosinor had serum Frosinor levels about one-third that of the mother's at birth. The infant was a genetic poor metabolizer which apparently was the cause of the high serum levels. Although the infant had symptoms attributed to Frosinor obtained in utero, the mother continued taking Frosinor 30 mg daily and breastfeeding (extent not stated). At 4 months of age, the infant had gained weight normally and had no evidence of neurological side effects.[20] An 18-month-old infant with a 2-week history of vomiting was found to have hypokalemia, hypochloremic alkalosis and mild dehydration. The infant had been admitted twice previously 2 and 3 months before with a similar picture. Serum renin and aldosterone were normal. The infant's mother had been taking Frosinor 40 mg daily for about 1 year for depression and breastfeeding the infant (extent not stated). Frosinor was detected, but not quantified, in the mother's breastmilk and infant's serum. Breastfeeding was discontinued and the infant was thriving 6 weeks later with a normal metabolic profile. The authors attributed the infant's metabolic abnormalities to Frosinor-induced syndrome of inappropriate secretion of antidiuretic hormone.[21] The reaction was possibly caused by Frosinor in breastmilk, but strong evidence was lacking and other possible causes cannot be ruled out. A small study compared the reaction to pain in infants of depressed mothers who had taken an SSRI during pregnancy alone or during pregnancy and nursing, to a control group of unexposed infants of nondepressed mothers. Infants exposed to an SSRI either prenatally alone or prenatally and postnatally via breastmilk had blunted responses to pain compared to control infants. Nineteen of the 30 infants were exposed to Frosinor. Because there was no control group of depressed, nonmedicated mothers, an effect due to maternal behavior caused by depression could not be ruled out. The authors stressed that these findings did not warrant avoiding drug treatment of depression during pregnancy or avoiding breastfeeding during SSRI treatment.[8] One study of side effects of SSRI antidepressants in nursing mothers found no adverse reactions that required medical attenti

Frosinor can cause galactorrhea, usually with increased prolactin levels, in nonpregnant, nonnursing patients.[28][29][30][31][32][33][34][35] In a study of cases of hyperprolactinemia and its symptoms (e.g., gynecomastia) reported to a French pharmacovigilance center, Frosinor was found to have a 3.1-fold increased risk of causing hyperprolactinemia compared to other drugs.[36] 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 citalopram, duloxetine, escitalopram, Frosinor 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.[37] 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 citalopram, 18 took escitalopram, 63 took fluoxetine, 2 took fluvoxamine, 78 took Frosinor, 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.[38] 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.[39] 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; Frosinor n = 53) 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.[40]