Study Finds No Link Between Fluconazole During Pregnancy and Stillbirth or Neonatal Death

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MedicalResearch.com Interview with:

Björn Pasternak,

Dr. Pasternak

Björn Pasternak, MD, PhD
Associate Professor,Clinical Epidemiology Division
Department of Medicine Solna
Karolinska Institutet
Stockholm, Sweden

MedicalResearch.com: What is the background for this study?

Response: To summarize the background for this study, there have been animal studies suggesting that oral fluconazole may give rise to fetal death. Given this background and the paucity of controlled human studies, we previously conducted a nationwide register-based study in Denmark, which was published in JAMA in 2016. In that study, we observed an increased risk of spontaneous abortion associated with fluconazole use in pregnancy. This prompted the European Medicines Agency to update the European label of fluconazole, warning about this potential adverse event. Further, findings in that study indicated that there could be an increased risk of stillbirth. We wanted to investigate this outcome further, in an independent data material, and also to investigate the outcome of neonatal death.

Here, we report the results of a bi-national study conducted on the basis of nationwide health care registers in Sweden and Norway. From a background cohort of close to 1.5 million deliveries, we identified more than 10,000 pregnancies exposed to oral fluconazole and matched these to more than 100,000 unexposed pregnancies.

MedicalResearch.com: What are the main findings?

Response: The main results are that oral fluconazole use during pregnancy was not associated with stillbirth (hazard ratio 0.76 [95% CI 0.52-1.10]) or neonatal death (risk ratio 0.73 [95% CI 0.42-1.29]). Further, results were similar in analyses according to fluconazole dose; that is, estimates did not differ for doses usually used for the treatment of vaginal candidiasis (single-dose 150 mg, used once or twice) and for higher doses.

MedicalResearch.com: What should readers take away from your report?

Response: The findings are reassuring with respect to stillbirth and neonatal death. However, the results should be interpreted considering other pregnancy safety issues with fluconazole, such as malformations, before recommendations to guide clinical decisions are made.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: Additional research is needed to understand the full spectrum of oral fluconazole safety in pregnancy. 

MedicalResearch.com: Is there anything else you would like to add?

Response: This study was supported by the Thrasher Research Fund, the Magnus Bergvall Foundation, and the Karolinska Institutet Research Foundation. Björn Pasternak and Olof Stephansson were also supported by the Strategic Research Area Epidemiology program at Karolinska Institutet.

No conflicts of interest

Citation: 

Pasternak B, Wintzell V, Furu K, Engeland A, Neovius M, Stephansson O. Oral Fluconazole in Pregnancy and Risk of Stillbirth and Neonatal Death. JAMA. 2018;319(22):2333–2335. doi:10.1001/jama.2018.6237 

 

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