What is known about reboxetine (Edronax) treatment during pregnancy?

Fråga: What is known about reboxetine (Edronax) treatment during pregnancy?

Sammanfattning: Data on reboxetine during pregnancy is very limited and its use should therefore be avoided. Animal studies do not indicate teratogenetic properties of reboxetine.

Svar: Reboxetine (Edronax) is a potent inhibitor of the reuptake of noradrenalin with a lesser inhibition potential on the reuptake of serotonin (1). The drug was approved in Sweden during October 1997.

No clinical studies addressing possible harmful effects of reboxetine during pregnancy have been published in the literature, but the experience of this drug is limited. There is only one case of reboxetine exposure during pregnancy reported in the Swedish Medical Birth Registry. In this case the woman delivered a healthy child (2). A total of 16 spontaneous reports of reboxetine use during pregnancy have been reported to the manufacture (3). The majority of these exposures are during the first trimester (N=10). This material is too scarce to allow proper risk assessment.

There are unpublished teratogenicity studies in rats and rabbits, referred to in the SPC presented by the manufacturer, that do not indicate that reboxetine has teratogenetic properties (1). Slightly reduced frequencies in postpartum survival were observed in rats at much higher doses than therapeutic ones.