Is loratadine considered to be safe during pregnancy?/nBackground: This antihistamine is available

Fråga: Is loratadine considered to be safe during pregnancy? Background: This antihistamine is available over-the-counter in Sweden (Clarityn, Versal), and as the hay fever season is approaching, many questions from pregnant women are expected.

Sammanfattning: There are no published reports of toxic effects on the embryo or fetus in loratadine-exposed pregnant women, despite a considerable number of exposed cases. Therefore, it appears that loratadine intake in pregnancy may be justified from a safety perspective.

Svar: The issue of loratadine safety during pregnancy has been addressed several times previously at the Drug Research and Information Centre, and some recent Drugline documents are enclosed (1, 2).

The main conclusion from these, as well as from more recent review articles (3, 4), is that there is no data in the literature suggesting that loratadine intake during pregnancy could be harmful to the embryo or fetus in humans, despite animal data suggestive of embryotoxicity (5).

Clinical studies are still lacking. However, as much as 1488 cases of loratadine-exposed pregnant women are now listed in the National Medical Birth Register (MBR). In this material, the frequency of malformations (2.15 per cent) was not different from that in the non-exposed population (2.14 per cent). Moreover, there was a similar distribution of different types of malformations in both groups. Taken together, the data speaks against a possible teratogenic effect of loratadine.