Can treatment with remoxipride (Roxiam) or clozapine (Leponex) during pregnancy be harmful to the i

Fråga: Can treatment with remoxipride (Roxiam) or clozapine (Leponex) during pregnancy be harmful to the infant?

A 31-year-old woman is treated with remoxipride 300 mg daily due to a paranoid psychosis. The patient now wants to become pregnant.

Sammanfattning: The possible teratogenic effects of clozapine and remoxipride are unclear. If treatment is necessary with an antipsychotic drug during pregnancy, the lowest possible dose is recommended to minimize fetal exposure. Treatment should also be discontinued about 10 days before delivery in order to minimize the risk of extrapyramidal symptoms in the neonate.

Svar: No data in the literature concerning the use of remoxipride during pregnancy could be located. Since 1993 remoxipride is only available on licence. According to (1) remoxipride is in category C. This corresponds to other classical neuroleptics such as chlorpromazine, which may produce extrapyrimidal adverse effects in the fetus during late pregnancy.

The manufacturer is aware of four cases of remoxipride treatment during pregnancy. In two of the cases treatment proceeded during the whole pregnancy with a dose of 40 mg and 600 mg respectively. In the other two cases treatment was only during one day after conception (dose unknown) and the first two months of pregnancy with a dose of 200 mg daily. All mothers delivered normal infants at the end of pregnancy (2).

The files of SADRAC (Swedish Adverse Drug Reactions Advisory Committee) contain one case of remoxipride treatment during pregnancy. In this case the dental enamel was found to be modified in the two-year-old child. Since no data in the literature could verify this effect on the child´s teeth, the assessment was unlikely.

There are few data regarding the use of atypical antipsychotics during pregnancy (3). Some clinical follow-up studies on clozapine have not been able to find any causal connection between clozapine and the occurrence of fetal malformations (3,4). In a review including 61 children born to 59 women who received clozapine therapy during pregnancy, five cases of congenital malformations and five cases of neonatal toxicity were seen. However, several of the mothers had treatment with other drugs that could have caused the congenital malformations in these children (3). According to (1) clozapine is also in category C. In contrast, children to women with psychoses may have an increased risk of malformations independently of antipsychotic exposure. In a study on women with psychoses with and without chlorpromazine, the rate of fetal damage was similar in both groups (3). 1 FASS 1992 (The Swedish catalogue of approved medical products) 2 Ingrid Edsman, Astra Arcus Safety 3 Trixler M, Tenyi T: Antipsychotic use in pregnancy: What are the best treatment options? Drug Safety 1997; 16: 403-410 4 Waldman MD, Safferman AZ: Pregnancy and clozapine. Am J Psychiatry 1993; 150: 168-169