Can I take venlafaxine while pregnant or breastfeeding?

8.1 Pregnancy Based on data from published observational studies, exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.13) and Clinical Considerations]. Teratogenic Effects Venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human daily dose on a mg/m 2 basis. However, in rats, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known. These effects occurred at 2.5 times (mg/m 2 ) the maximum human daily dose. The no effect dose for rat pup mortality was 0.25 times the human dose on a mg/m 2 basis. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): venlafaxine hydrochloride, extended release (oral), Edenbridge Pharmaceuticals LLC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

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. Some experts feel that venlafaxine is not recommended during nursing.[1] 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. Maternal poor metabolism by metabolic enzymes does not appear to result in excessive infant serum concentrations. Bruxism was reported in one infant.

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. Breastfed infants exposed to venlafaxine during the third trimester of pregnancy are at risk for neonatal withdrawal syndrome consisting of hypoglycemia, tremors, tachycardia, or hypotonia, and might be at a greater risk of readmission due to jaundice.[2,3] Use of venlafaxine during breastfeeding has been proposed as a method of mitigating infant venlafaxine withdrawal symptoms, and institution of maternal milk feeding of mothers taking venlafaxine has reversed symptoms of neonatal abstinence.[4-6]

“Summary of Use during Lactation”, LactMed record “Venlafaxine” (LM329), quoted verbatim. Everything LactMed reports about Venlafaxine while breastfeeding.

Nursing Mothers Venlafaxine and ODV have been reported to be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Venlafaxine Hydrochloride Extended-Release Tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Prescribing label, section “Nursing Mothers”: venlafaxine hydrochloride, extended release (oral), Edenbridge Pharmaceuticals LLC. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.