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Use of oral fluconazole during pregnancy is not associated with an increase in risk of stillbirth or neonatal death, results of a large European cohort study suggest.
The rate of stillbirths was 2.7 per 1,000 fluconazole-exposed pregnancies, versus 3.6 per 1,000 unexposed pregnancies (hazard ratio, 0.76, 95% confidence interval, 0.52-1.10), investigators reported based on an analysis of national registry data including nearly 1.5 million recent pregnancies in Sweden and Norway.
Neonatal deaths occurred in 1.2 per 1,000 exposed pregnancies and 1.7 per 1,000 unexposed pregnancies, investigators added in the report, which appeared in JAMA.
Results were not different for doses of 300 mg or less versus more than 300 mg, said senior researcher Björn Pasternak, MD, PhD, of Karolinska Institutet, Stockholm, and his co-authors.
“Although the data on fluconazole use in pregnancy suggest no increased risk of stillbirth, additional studies should be conducted and the collective body of data scrutinized by drug authorities before recommendations to guide clinical decision making are made, and weighed against the benefits of therapy,” the investigators wrote.
About 4% of pregnant women in the United States take oral fluconazole, even though it is generally discouraged during pregnancy due to concerns that its use may be associated with stillbirth in a previous Danish nationwide register-based study, published in JAMA.
In 2016, investigators similarly found no increased risk of stillbirth in 2,215 fluconazole-exposed women, though they noted the outcome was “relatively rare and the results therefore imprecise.” In a sensitivity analysis, they did find an association between higher doses of fluconazole (i.e., above 300 mg) and stillbirth, with a hazard ratio of 4.10 (95% CI, 1.89-8.90).
The stillbirth analysis in the present study included 10,669 fluconazole-exposed pregnancies from Sweden and Norway, though the number exposed to higher doses was small, Dr. Pasterak and co-authors said in their report.
Although more research and deliberation is needed, this new study does add one novel endpoint to the literature: “The outcome of neonatal death has not been reported previously, to our knowledge.”
Their study was supported by the Thrasher Research Fund, the Magnus Bergvall Foundation, and the Karolinska Institutet Research Foundation. Dr. Pasternak and co-authors reported no conflicts of interest.
SOURCE: Pasternak B, et al. JAMA. 2018 Jun 12;319:22.
Use of oral fluconazole during pregnancy is not associated with an increase in risk of stillbirth or neonatal death, results of a large European cohort study suggest.
The rate of stillbirths was 2.7 per 1,000 fluconazole-exposed pregnancies, versus 3.6 per 1,000 unexposed pregnancies (hazard ratio, 0.76, 95% confidence interval, 0.52-1.10), investigators reported based on an analysis of national registry data including nearly 1.5 million recent pregnancies in Sweden and Norway.
Neonatal deaths occurred in 1.2 per 1,000 exposed pregnancies and 1.7 per 1,000 unexposed pregnancies, investigators added in the report, which appeared in JAMA.
Results were not different for doses of 300 mg or less versus more than 300 mg, said senior researcher Björn Pasternak, MD, PhD, of Karolinska Institutet, Stockholm, and his co-authors.
“Although the data on fluconazole use in pregnancy suggest no increased risk of stillbirth, additional studies should be conducted and the collective body of data scrutinized by drug authorities before recommendations to guide clinical decision making are made, and weighed against the benefits of therapy,” the investigators wrote.
About 4% of pregnant women in the United States take oral fluconazole, even though it is generally discouraged during pregnancy due to concerns that its use may be associated with stillbirth in a previous Danish nationwide register-based study, published in JAMA.
In 2016, investigators similarly found no increased risk of stillbirth in 2,215 fluconazole-exposed women, though they noted the outcome was “relatively rare and the results therefore imprecise.” In a sensitivity analysis, they did find an association between higher doses of fluconazole (i.e., above 300 mg) and stillbirth, with a hazard ratio of 4.10 (95% CI, 1.89-8.90).
The stillbirth analysis in the present study included 10,669 fluconazole-exposed pregnancies from Sweden and Norway, though the number exposed to higher doses was small, Dr. Pasterak and co-authors said in their report.
Although more research and deliberation is needed, this new study does add one novel endpoint to the literature: “The outcome of neonatal death has not been reported previously, to our knowledge.”
Their study was supported by the Thrasher Research Fund, the Magnus Bergvall Foundation, and the Karolinska Institutet Research Foundation. Dr. Pasternak and co-authors reported no conflicts of interest.
SOURCE: Pasternak B, et al. JAMA. 2018 Jun 12;319:22.
Use of oral fluconazole during pregnancy is not associated with an increase in risk of stillbirth or neonatal death, results of a large European cohort study suggest.
The rate of stillbirths was 2.7 per 1,000 fluconazole-exposed pregnancies, versus 3.6 per 1,000 unexposed pregnancies (hazard ratio, 0.76, 95% confidence interval, 0.52-1.10), investigators reported based on an analysis of national registry data including nearly 1.5 million recent pregnancies in Sweden and Norway.
Neonatal deaths occurred in 1.2 per 1,000 exposed pregnancies and 1.7 per 1,000 unexposed pregnancies, investigators added in the report, which appeared in JAMA.
Results were not different for doses of 300 mg or less versus more than 300 mg, said senior researcher Björn Pasternak, MD, PhD, of Karolinska Institutet, Stockholm, and his co-authors.
“Although the data on fluconazole use in pregnancy suggest no increased risk of stillbirth, additional studies should be conducted and the collective body of data scrutinized by drug authorities before recommendations to guide clinical decision making are made, and weighed against the benefits of therapy,” the investigators wrote.
About 4% of pregnant women in the United States take oral fluconazole, even though it is generally discouraged during pregnancy due to concerns that its use may be associated with stillbirth in a previous Danish nationwide register-based study, published in JAMA.
In 2016, investigators similarly found no increased risk of stillbirth in 2,215 fluconazole-exposed women, though they noted the outcome was “relatively rare and the results therefore imprecise.” In a sensitivity analysis, they did find an association between higher doses of fluconazole (i.e., above 300 mg) and stillbirth, with a hazard ratio of 4.10 (95% CI, 1.89-8.90).
The stillbirth analysis in the present study included 10,669 fluconazole-exposed pregnancies from Sweden and Norway, though the number exposed to higher doses was small, Dr. Pasterak and co-authors said in their report.
Although more research and deliberation is needed, this new study does add one novel endpoint to the literature: “The outcome of neonatal death has not been reported previously, to our knowledge.”
Their study was supported by the Thrasher Research Fund, the Magnus Bergvall Foundation, and the Karolinska Institutet Research Foundation. Dr. Pasternak and co-authors reported no conflicts of interest.
SOURCE: Pasternak B, et al. JAMA. 2018 Jun 12;319:22.