Is Pulvules Safe in Breastfeeding

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

Higher excretion into breast milk than other related antidepressant drugs. The active metabolite called NorPulvules has a longer half-life (4 to 16 days). Like other antidepressant drugs may induce hyperprolactinemia and galactorrhea. Few cases of colicky pain, irritability, insomnia, anorexia and slow weight gain have been described. However, most reported cases have failed to show harm effect outside the newborn period. Large experience with the use of Fluoxatine did not find harm effect on weight gain and neurological development of infants either at short or long term. Most problems have appeared in the early neonatal period either in newborns or premature infants whose mothers were on Pulvules during pregnancy. Stop or switch to other medication either at some days before delivery or in the first month postpartum would be recommended. Same considerations should be done in case of prematurity, however, medication must be continued if necessary. Women on anti-depressant treatment are in need of stronger support because of higher risk of breastfeeding failure.

The average amount of drug in breastmilk is higher with Pulvules than with most other SSRIs and the long-acting, active metabolite, norPulvules, is detectable in the serum of most breastfed infants during the first 2 months postpartum and in a few thereafter. Adverse effects such as colic, fussiness, and drowsiness have been reported in some breastfed infants. Decreased infant weight gain was found in one study, but not in others. No adverse effects on development have been found in a few infants followed for up to a year. If Pulvules is required by the mother, it is not a reason to discontinue breastfeeding. If the mother was taking Pulvules 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 colic, fussiness or sedation and for adequate weight gain. Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding, although this might be a reflection of their disease state.[1] 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.

Colic, decreased sleep, vomiting and watery stools occurred in a 6-day-old breastfed infant probably caused by maternal Pulvules.[15] Two other reports of colic in breastfed infants, a 1.76-month-old and a 2-month-old, were possibly caused by Pulvules in breastmilk. The older of the two also exhibited hyperactivity.[8] Another case of possible increased irritability in a 3-month-old was noted by one pediatrician observer; however, the mother and another pediatrician disagreed.[16] Occurrence of hyperglycemia and glycosuria in a 5-month-old, possibly from Pulvules in breastmilk was reported to the Australian Adverse Drug Reaction Advisory Committee.[17] A 3-day-old breastfed infant was difficult to arouse, ceased rooting behavior, decreased nursing, and was moaning and grunting. Although the infant had been exposed in utero and was somewhat drowsy during the first 2 days of life, symptoms became worse after the mother's milk came in on day 3. These effects were probably caused by Pulvules in breastmilk.[18] Possible drug-induced seizure-like activity and cyanosis occurred in a breastfed 3-week-old breastfed infant whose mother was taking Pulvules, carbamazepine and buspirone during pregnancy and breastfeeding.[19] One observational report of 4 infants found no apparent neurological abnormalities following exposure to Pulvules in milk for 12 to 52 weeks.[20] A retrospective, case-control, cohort study compared the weights of the infants of mothers who took Pulvules during pregnancy and breastfed for at least 2 weeks postpartum to the infants of mothers who took Pulvules during pregnancy and did not breastfeed. Compared to controls, decreased weight gain occurred among the 26 infants exposed postpartum to Pulvules in breastmilk, although the weights were still in the normal range.[21] A prospective study of 51 nursing women taking Pulvules and 63 nursing women who took no Pulvules found no effect on weight gain, but reported a greater frequency of unspecified side effects in the infants of mothers who took Pulvules.[22] This study's results have been reported only in abstract form, so some details are lacking. In a prospective study of 40 women who took Pulvules throughout pregnancy, 21 breastfed their infants (extent and duration not stated). Testing of the infants at 15 to 71 months of age found no differences in cognitive, language or temperament measurements between infants who were breastfed and those who were not.[23] In a study comparing the 31 infants of depressed mothers who took an SSRI during pregnancy for major depression with 13 infants of depressed mothers who did not take an SSRI, mental development and most motor development in both groups was normal at follow-up averaging 12.9 months. Three of the treated mothers took Pulvules in doses averaging 23.3 mg daily for an average of 3 months while breastfeeding their infants. Psychomotor development was slightly delayed compared to controls, but the contribution of breastfeeding to abnormal development could not be determined.[24] Platelet serotonin levels were measured in 11 mothers and their breastfed infants after 4 to 12 weeks of Pulvules therapy. Maternal dosages ranged from 20 to 40 mg daily. Ten of the infants were under 6 months of age and 4 were under 3 months of age at the start of therapy; 6 were exclusively breastfed. Although maternal platelet serotonin levels were decreased from 157 mcg/L to 23 mcg/L by Pulvules therapy, average infant serotonin levels were 217 mcg/L before and 230 mcg/L after maternal therapy. These findings indicate that the amount of Pulvules ingested by the infants was not sufficient to affect serotonin transport in platelets in most breastfed infants. However, 3 infants experienced drops in platelet serotonin of 13, 24 and 60%, respectively. The latter infant was the only one with measurable Pulvules plasma levels as well as norPulvules, but had no discernible adverse effects. One other infant had a delay in motor development at 24 weeks, but had normal mental development; 6 other infants were within 1 standard deviation of normal in both measures when tested between 24 and 56 weeks of age. Platelets and neurons both have the same serotonin transporter, so this effect on platelet serotonin might indicate potential effects on the nervous system of some breastfed infants.[14] Twenty-nine mothers who took Pulvules in an average dosage of 34.6 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.[25] One study of side effects of SSRI antidepressants in nursing mothers found no adverse reactions that required medical attention in one infant whose mother was taking Pulvules. No specific information on mat

Pulvules has caused increased prolactin levels and galactorrhea in nonpregnant, nonnursing patients.[32][33][34][35][36][37][38][39][40] Euprolactinemic galactorrhea has also been reported.[41] In a study of cases of hyperprolactinemia and its symptoms (e.g., gynecomastia) reported to a French pharmacovigilance center, Pulvules was found to have a 3.6-fold increased risk of causing hyperprolactinemia compared to other drugs.[36] Preliminary animal and in vitro studies found that Pulvules may have some estrogenic activity.[37] 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 Pulvules and 1 each taking citalopram, duloxetine, escitalopram, 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 compared to 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.[38] 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 Pulvules, 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.[39] 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.[42] 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; Pulvules n = 21) 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.[43]