Is itraconazole teratogenic?/nA pregnant woman had her last menstruation 9 or 5 weeks ago (uncertai
Fråga: Is itraconazole teratogenic? A pregnant woman had her last menstruation 9 or 5 weeks ago (uncertain if the last period was a real one). Six weeks ago, she started medicating with Sporanox (itraconazole) 400 mg daily, but stopped treatment after only one day.
Sammanfattning: There seems to be an increased incidence of spontaneous abortion following exposure to itraconazole, but no significantly increased risk of major malformations in the live born children. Human data is still insufficient to completely rule out an increased risk of rare birth defects. In this specific case, the exposure was brief and in early pregnancy (possibly even prior to conception) and the risk of teratogenic effects therefore seems negligible.
Svar: A question about itraconazole and pregnancy has previously been answered in Drugline (1). It was then concluded that high doses given to rodents resulted in skeletal and neural tube defects in the embryo. The available human data did not indicate any teratogenicity, although it was too scarce to rule out such effects with certainty.
An updated Medline search revealed a prospective cohort study in 229 women exposed to itraconazole (198 during the first trimester) and matched unexposed controls (2). The rate of major malformations was 3.2 percent in the exposed group compared with 4.8 percent in the control group, resulting in a relative risk of 0.67 (95 percent CI 0.23-1.95). However, the rate of spontaneous abortion was higher in the exposed group with a RR of 1.75 (1.47-2.09).
In the Swedish Medical Birth Registry, there are 20 reports of itraconazole exposure during pregnancy (3). One of the exposed children had hypospadia, but the number of reports is obviously too small to permit any conclusions.
Fluconazole, a closely related substance has been studied in large groups of pregnant women without any teratogenic or fetotoxic effects shown (4).