What is the field experience of treatment with Zoloft (sertraline) during pregnancy? What are the p

Fråga: What is the field experience of treatment with Zoloft (sertraline) during pregnancy? What are the possible effects on the fetus?

Sammanfattning: The only information that could be found was one report of neonatal withdrawal symtoms, five cases of adverse events reported to the manufacturer, and 58 uneventful pregnancies.

Since sertraline is a relatively new drug and the experience of its use in pregnancy is therefore limited its use during pregnancy cannot be recommended.

Svar: A thorough literature search including Drugline, Medline and common pharmacological handbooks gave a meagre result.

Briggs says that no reports describing the use of sertraline in human pregnancy have been located. Animal studies have not revealed any teratogenicity but a probable direct effect on the fetuses resulting in decreased neonatal survival was observed with maternal doses as low as 5 times the maximum human mg/kg dose (1).

One letter was also found reporting neonatal withdrawal symtoms when the mother had been treated with 200 mg sertraline throughout the pregnancy, she was also treated with lithium and thioridazine for the first 6 weeks of her pregnancy. The pregnancy proceeded without any complications and she continued treatment with sertraline until 3 weeks postpartum, when it was stopped abruptly. She had breast-fed since delivery.

The baby, previously feeding and developing well, after one day developed symtoms of agitation, restlessness, poor feeding, constant crying, insomnia and an enhanced startle reaction. These symtoms were intense for approximately a further 48 hours and then began to subside over the next few days. The mother remained well with no adverse symtoms after stopping sertraline.

The explanation given for the delay of onset of symtoms was that the breast-milk contained enough sertraline (2).

Similar symptoms are described for the older antidepressants. Several Drugline documents describe abstinence in infants post-partum when the mother has been treated with tricyclic antidepressants during pregnancy (3).

Personal communication with the manufacturer revealed that they have reports on twelve events where they had judged five as possible effects of sertraline. The events judged as possible were two miscarriages, one cystic hygroma, one VATER syndrome (vertebral defects, imperforate anus, transesophageal fistula and radial and renal dysplasia) and one baby with seizures. The connection with the sertraline treatment is unclear and some of the mothers had other medication as well. No information was given about the total number of women treated with sertraline during pregnancy (4).

The Motherisk program has 58 follow-ups where women have been treated with sertraline during pregnancy. No harmful effects were seen (5).