Venlafaxine use while Breastfeeding
Drugs containing Venlafaxine: Effexor, Effexor XR
Venlafaxine Levels and Effects while Breastfeeding
Summary of Use during Lactation
Infants receive venlafaxine and its active metabolite in breastmilk, and the metabolite of the drug can be found in the plasma of most breastfed infants; however, concurrent side effects have rarely been reported. Breastfed infants, especially newborn or preterm infants, should be monitored for excessive sedation and adequate weight gain if this drug is used during lactation, possibly including measurement of serum levels of desvenlafaxine (O-desmethylvenlafaxine), to rule out toxicity if there is a concern. However, newborn infants of mothers who took the drug during pregnancy may experience poor neonatal adaptation syndrome as seen with other antidepressants such as SSRIs or SNRIs. Use of venlafaxine during breastfeeding has been proposed as a method of mitigating infant venlafaxine withdrawal symptoms, but this has not been rigorously demonstrated.
Venlafaxine is metabolized to a metabolite, desvenlafaxine, that has antidepressant activity similar to that of venlafaxine.
Maternal Levels. Three mothers with infants aged 0.37, 1.3 and 6 months were taking venlafaxine in doses of 3.04 to 8.18 mg/kg daily for at least a week. Peak breastmilk levels of venlafaxine and its active metabolite, desvenlafaxine, occurred 1 to 3 hours after the dose in 2 of the mothers. Infants received an average of 7.6% (range 4.7 to 9.2%) of the maternal weight-adjusted dosage of venlafaxine plus desvenlafaxine.
Six women averaging 7 months postpartum were receiving venlafaxine 225 to 300 mg daily for at least 18 days; 1 was taking the sustained-release (SR) formulation once daily and the others took 2 divided doses daily. In the women taking immediate-release product, the time of the peak milk levels averaged 2 hours (range 1.7 to 2.8 hours) for venlafaxine and 2.8 hours (range 1.8 to 4.2 hours) for desvenlafaxine. For the SR formulation, peak venlafaxine and desvenlafaxine levels occurred at 5.7 and 7.7 hours, respectively. The authors estimated that an exclusively breastfed infant would receive an average of 6.4% (range 5.2 to 7.4%) of the maternal weight-adjusted dosage of venlafaxine as the drug plus metabolite.
Three women were taking venlafaxine during breastfeeding in doses of 37.5, 75 and 225 mg daily. Milk samples were taken 8 hours after a dose and measured for venlafaxine and desvenlafaxine. The infants were estimated to have received 11.8%, 3% and 6.3% of the weight-adjusted maternal dosage.
In 3 women 8 to 30 weeks postpartum who were taking venlafaxine 75 to 225 mg daily, the authors calculated that their fully breastfed infants would receive an average of 5.2% of the maternal dosage, primarily as desvenlafaxine.
A woman who was taking venlafaxine 375 mg daily during pregnancy and postpartum had a combined breastmilk level of 690 mcg/L of venlafaxine and 2 metabolites. The authors estimated that the breastfed infant was receiving at least 3.5% of the maternal weight-adjusted dosage.
Two women who were 6.5 and 9.5 weeks postpartum and taking venlafaxine 75 mg and 225 mg daily had their milk measured at unreported times after their doses. The venlafaxine concentrations in their milk were 103 and 327 mcg/L, respectively.
Eleven women taking an average of 194 mg of venlafaxine daily (1 as immediate-release and 10 as sustained-release) had their breastmilk venlafaxine and desvenlafaxine concentrations measured. The estimated excretion of the drug and metabolite into breastmilk was 8.1% (range 3.2 to 13.3%) of the weight-adjusted maternal dosage. The peak drug concentration in breastmilk occurred at about 8 hours after the dose; desvenlafaxine was the primary contributor to total milk concentration. The estimated infant dosage was 0.208 mg/kg daily (range 0.07 to 0.38 mg/kg daily), which translates to 6.4% of the maternal weight-adjusted dosage.
Infant Levels. Three breastfed (extent not stated) infants aged 0.37, 1.3 and 6 months whose mothers were taking venlafaxine 3.04 to 8.18 mg/kg daily had undetectable (<10 mcg/L) venlafaxine and an average of 100 mcg/L (range 23 to 225 mcg/L) of desvenlafaxine in their plasma.
Two mothers on stable doses of venlafaxine 75 and 150 mg daily exclusively breastfed their infants for 6 months. At ages 3 and 4 weeks, respectively, venlafaxine was undetectable (<10 mcg/L) in the serum of both infants. Desvenlafaxine was detectable in their serum at 16 and 21 mcg/L, respectively.
Three breastfed (extent not stated) infants whose mothers were taking venlafaxine 37.5, 75 and 225 mg daily had blood samples taken 8 hours after the previous maternal dose. The infants, whose ages were 3, 10.4 and 14.6 weeks, had venlafaxine serum levels of 9 mcg/L, <3 mcg/L and undetectable; desvenlafaxine serum levels were <8, 7.5 and 12.5 mcg/L, respectively.
Of 7 breastfed (extent not stated) infants with an average age of 7 months, including 1 set of twins, whose mothers were taking 225 to 300 mg of venlafaxine daily, only 1 (maternal dose 225 mg daily) had a measurable serum level of venlafaxine of 5 mcg/L (detection limit 1 mcg/L). Measurable desvenlafaxine serum levels were 3, 6, 20 and 38 mcg/L in 4 of the 7 infants.
In 3 breastfed (extent not stated) infants aged 8 to 30 weeks whose mothers were taking venlafaxine 75 to 225 mg daily, their serum drug levels were 10.2% of those of their mothers, mostly as desvenlafaxine.
Six nursing infants (average 20 weeks; range 7.3 to 60 weeks of age) whose mothers were taking an average of 206 mg daily of venlafaxine had their serum analyzed for venlafaxine and desvenlafaxine. Five were exclusively breastfed and 1 was about 50% breastfed. Five of the 6 had no detectable (<2 mcg/L) venlafaxine in their serum, and 1 had a concentration of 5 mcg/L. Two infants, including the one who was partially breastfed had no detectable desvenlafaxine in their serum; the other 4 had desvenlafaxine concentrations ranging from 4 to 243 mcg/L. The group of infants had an average serum concentrations of the drug and metabolite of 37% that of their mothers' serum.
Effects in Breastfed Infants
No acute adverse effects or abnormal weight gain were seen in 3 breastfed infants who had detectable serum levels of desvenlafaxine.
No adverse effects on growth or in sleep, feeding or behavioral patterns were noticed clinically in 2 infants who were exclusively breastfed for 6 months during maternal therapy with venlafaxine 75 and 150 mg daily.
Three mothers took an average venlafaxine dose of 162.5 mg once daily. They 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.
Seven infants (including 1 set of twins) breastfed for 2.7 to 10.3 months during maternal venlafaxine therapy. Three mothers were taking venlafaxine since birth and 3 were started later. Denver Developmental Screening Tests in all infants were normal. All but 2 had normal growth; these 2 had a decrease in weight gain.
In 3 infants aged 8 to 30 weeks whose mothers were taking venlafaxine 75 to 225 mg daily, no adverse reactions were noted clinically at the time of the study.
An newborn infant whose mother had been taking venlafaxine 375 mg daily during pregnancy had symptoms of lethargy, poor sucking ability, and dehydration at 2 days of age. The infant was allowed to breastfeed and the symptoms subsided over 1 week. The authors concluded that the symptoms were likely withdrawal symptoms that were mitigated by the venlafaxine in breastmilk. Another infant whose mother was taking venlafaxine 300 mg daily was reported by the same center. In this case, the infant's symptoms of withdrawal improved markedly on day 7 when breastfeeding was initiated, but no drugs levels were measured in milk or in the infant.
Two nursing mothers were taking venlafaxine and quetiapine for postpartum depression; one was also taking trazodone. Their breastfed infants' development were tested at 12 to13 months of age with the Bayley Scales. Scores were within normal limits on the mental, psychomotor and behavior scales.
Thirteen infants whose mothers were taking venlafaxine in doses ranging from 37.5 to 300 mg daily were breastfed (11 exclusively and 2 about 50%). Three of the infants were also exposed to a second psychotropic drug in breastmilk: 1 each of buspirone, trazodone, quetiapine. None of the infants had any adverse reactions reported by their mothers or in their medical records.
Two nursing mothers who were 6.5 and 9.5 weeks postpartum were taking venlafaxine in doses of 75 and 225 mg daily, respectively, in addition to quetiapine for major depression postpartum; one mother was also taking trazodone. Their breastfed infants' development were tested at 9 to 18 months of age with the Bayley Scales. Both infants had scores that were within normal limits.
A mother was taking venlafaxine 75 mg daily for depression and anxiety, although when the drug was started is not clear from the report. Her 1-month-old infant was seen in a pediatric clinic and was demonstrating agitation, infantile colic, drowsiness, increased startle response, jitteriness and sleeplessness. The symptoms began at 1 week of age and became progressively worse over time and with breastfeeding. The symptoms were possibly caused by venlafaxine, although whether they represent a withdrawal reaction of direct drug effects cannot be determined.
A woman with depression and anxiety was treated with venlafaxine 300 mg daily monotherapy beginning at 20 weeks of pregnancy. On day three of life, the infant had extensor posturing and cycling of the limbs which was thought to be seizure related. Clinical examination was normal. Her suck was noted to be strong but uncoordinated and the infant fatigued rapidly. The infant was partially breastfed initially, but when breastmilk feeding was discontinued, the infant''s alertness improved and she gained 314 grams over 7 days. The authors felt that venlafaxine in breastmilk might have contributed to the infant's lethargy, especially given the high maternal dosage. The symptoms were possibly caused by venlafaxine in breastmilk.
Effects on Lactation and Breastmilk
Cases of galactorrhea and elevated serum prolactin have been reported in which venlafaxine played a primary or secondary role in the etiology. Galactorrhea with normal prolactin levels has also been reported. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
One mother who was nursing a 10.3-month-old infant reported that her milk letdown took longer after starting venlafaxine 1 month earlier.
Alternate Drugs to Consider
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