Terbinafine use safe during pregnancy: JAMA
A new study published in JAMA Dermatology has declared Terbinafine use safe during pregnancy. Terbinafine is assigned as category B to pregnancy by the FDA.
Denmark: Terbinafine is a commonly used antifungal agent, but safety data of its use in pregnancy are limited. It has been assigned to pregnancy category B by the FDA.
A recent study publishes in the JAMA Dermatology shows that both oral and topical forms of the antifungal agent terbinafine seem safe to use during pregnancy. A nationwide, registry-based cohort study was conducted in Denmark from January 1, 1997, to December 31, 2016, which included 1, 650, 649 pregnancies.
Based on the study, oral terbinafine-exposed (n = 891 pregnancies) and topical terbinafine-exposed (n = 3174) pregnancies were identified; up to a total of 40, 650 unexposed pregnancies were included for the matched outcome analyses.
In the view of the risk of major malformations, the prevalence odds ratios were
1)1.01 for oral terbinafine-exposed vs unexposed pregnancies,
2)1.08 for topical terbinafine-exposed vs unexposed pregnancies, and
3)1.18 for oral vs topical terbinafine-exposed pregnancies.
With respect to the risk of spontaneous abortion, the hazard ratios were
1)1.06 for oral terbinafine-exposed vs unexposed pregnancies,
2)1.04 for topical terbinafine-exposed vs unexposed pregnancies, and
3)1.19 for oral vs topical terbinafine-exposed pregnancies.
No statistically significant associations were seen in sensitivity analyses of any of the comparisons.
The researchers concluded that among pregnancies exposed to oral or topical terbinafine, no increased risk of major malformations or spontaneous abortion was identified.
"Our results may provide reassurance for pregnancies exposed to terbinafine, as well as help inform clinicians, patients, and drug regulatory authorities," stated Dr Niklas Worm Andersson of University Hospital Bispebjerg and Frederiksberg in Copenhagen. "However, given that this is the first published observational study to examine the association between terbinafine use in pregnancy and fetal safety outcomes, additional studies are needed to confirm and expand on these findings.", he added.
Dr Jenny Murase of the Palo Alto Foundation Medical Group in Mountain View, CA, co-author of a related editorial, added that although terbinafine is likely the safest anti-fungal medication to use during pregnancy, it is always important to question the appropriateness of treating non-life-threatening issues during pregnancy and lactation.
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