Frågedatum: 1999-04-19
RELIS database 1999; id.nr. 14917, DRUGLINE
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Is fluoxetine or naproxen teratogenic?/nA 33-year-old woman has been treated with fluoxetine (Fonte



Fråga: Is fluoxetine or naproxen teratogenic?

A 33-year-old woman has been treated with fluoxetine (Fontex) since 8 months. She also takes naproxen (Pronaxen) now and then. The patient is now pregnant and had the last menstruation 15/7. She stopped fluoxetine treatment 17/8. The patient believes that the fetus is about three weeks old.

Sammanfattning: There are no reports that fluoxetine could cause major congenital malformations.

In the present case the treatment was stopped 4 weeks after the last menstruation and this early exposure should impose no increased risk.

Naproxen does not cause teratogenic effects but should not be given during the last trimester before delivery.

Svar: Fluoxetine is a selective serotonine reuptake inhibitor (SSRI). The regional drug information centres in Sweden have answered questions about fluoxetine and pregnancy before (1-4). In summary there is no indication that fluoxetine could cause major congenital malformations, but the incidence of minor malformations was increased. According to a reference (5) the increase in perinatal complications after fluoxetine exposure late in pregnancy is a serious concern. It is added that the increased incidence of spontaneous abortions during fluoxetine treatment needs further investigations.

In a case report potential fluoxetine toxicity in a newborn was reported (6). The mother had an obsessive-compulsive disorder treated with fluoxetine, 60 mg daily. She delivered a boy who was jittery and hypertonic after birth with mild grunting, flaring and retracting. Scattered petechiae on the face and the trunk was seen and the boy had a small subdural hematoma and a clavicular fracture. The infants serum fluoxetine levels the second day was 129 ng/ml (normal: 91-302 ng/ml for adults) and its metabolite norfluoxetine was 227 ng/ml (normal: 72-258 ng/ml for adults). At 5-month follow-up, the infant was normal.

There are no reports of teratogenic effects during naproxen treatment (7) according to a literature search. Naproxen should not be used the last trimester before delivery to avoid early closing of ductus arteriosus in utero.

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