Evaluation of Association Between Oral and Topical Terbinafine Use in Pregnancy and Risk of Major Malformations and Spontaneous Abortion

Andersson, Niklas Worm; Thomsen, Simon Francis; Andersen, Jón Trærup

doi:10.1001/jamadermatol.2020.0142

Cited by 17 publications

(9 citation statements)

References 32 publications

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“…Recent studies conclude terbinafine as a safe oral drug in pregnancy. 89 Choice of drugs in special situations is summarized as in Table 4.…”

Section: Use Of Systemic Antifungals In Special Situationsmentioning

confidence: 99%

The unprecedented epidemic-like scenario of dermatophytosis in India: III. Antifungal resistance and treatment options

Verma¹,

Panda²,

Nenoff³

et al. 2021

IJDVL

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One of the canonical features of the current outbreak of dermatophytosis in India is its unresponsiveness to treatment in majority of cases. Though there appears to be discordance between in vivo and in vitro resistance, demonstration of in vitro resistance of dermatophytes to antifungals by antifungal susceptibility testing is essential as it may help in appropriate management. The practical problem in the interpretation of antifungal susceptibility testing is the absence of clinical breakpoints and epidemiologic cutoff values. In their absence, evaluation of the upper limit of a minimal inhibitory concentration of wild type isolates may be beneficial for managing dermatophytosis and monitoring the emergence of isolates with reduced susceptibility. In the current scenario, most of the cases are unresponsive to standard dosages and duration of treatment recommended until now. This has resulted in many ex-cathedra modalities of treatment that are being pursued without any evidence. There is an urgent need to carry out methodical research to develop an evidence base to formulate a rational management approach in the current scenario.

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“…Recent studies conclude terbinafine as a safe oral drug in pregnancy. 89 Choice of drugs in special situations is summarized as in Table 4.…”

Section: Use Of Systemic Antifungals In Special Situationsmentioning

confidence: 99%

The unprecedented epidemic-like scenario of dermatophytosis in India: III. Antifungal resistance and treatment options

Verma¹,

Panda²,

Nenoff³

et al. 2021

IJDVL

View full text Add to dashboard Cite

show abstract

“…To our knowledge, no studies to date have evaluated the safety of oral terbinafine in infants exposed during lactation, but experts recommend avoiding its use during lactation because it is often taken for long periods . Future studies, similar to the one by Andersson et al, should assess this risk. In the meantime, while griseofulvin might be tumorigenic, oral fluconazole and ketoconazole are safe for use during lactation and can be alternatives if patients or clinicians are leery of oral terbinafine use .…”

mentioning

confidence: 99%

“…1,3,4 Owing to the limited safety data, terbinafine has not been recommended for therapy in pregnancy or lactation, and its use during those periods remains controversial. 1,3 The retrospective cohort study by Andersson et al 5 in this issue of JAMA Dermatology helps to settle part of this controversy. The authors investigated the risk of major malformations and spontaneous abortion following exposure to oral or topical terbinafine during pregnancy.…”

mentioning

confidence: 99%

“…7 However, griseofulvin has been shown to cross the placenta and be tumorigenic and teratogenic in rodents at high doses, and 1 account of conjoined twins has been reported with oral griseofulvin. 8 In light of those data, the study by Andersson et al 5 suggests that oral and topical terbinafine may be one of the safest, if not the safest, option to treat fungal infections in the pregnant population.…”

mentioning

confidence: 99%

“…The retrospective cohort study by Andersson et al in this issue of JAMA Dermatology helps to settle part of this controversy. The authors investigated the risk of major malformations and spontaneous abortion following exposure to oral or topical terbinafine during pregnancy.…”

mentioning

confidence: 99%

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Oral and Topical Terbinafine for Fungal Infections in Pregnancy

Abel

Murase

2020

JAMA Dermatol

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Antifungal medication use during pregnancy and the risk of selected major birth defects in the National Birth Defects Prevention Study, 1997–2011

Papadopoulos,

Howley,

Fisher

et al. 2023

Pharmacoepidemiology and Drug

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PurposeRecent studies suggest increased birth defect risk associated with maternal use of specific oral antifungals. We estimated associations between first‐trimester antifungal use and selected non‐cardiac birth defects using National Birth Defects Prevention Study (NBDPS) data.MethodsParticipants with a pregnancy affected by a study‐eligible birth defect (“cases”) were ascertained from 10 birth defect surveillance programs; participants who delivered livebirths without a major birth defect (“controls”) were randomly selected from birth records or hospital discharge lists. First‐trimester antifungal use was self‐reported via maternal interview. We estimated adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for birth defects with ≥5 exposed cases using logistic regression. We estimated crude ORs and exact 95% CIs for birth defects with 3–4 exposed cases. Additionally, we conducted a probabilistic bias analysis of exposure misclassification.ResultsOur analysis included 19 624 cases and 11 427 controls; 257 (1.3%) cases and 123 (1.1%) controls reported first‐trimester antifungal use. Of those who reported antifungals, 62.6% of cases and 64.2% of controls reported topical antifungals; 10.1% of cases and 4.9% of controls reported oral antifungals. We observed the strongest associations for encephalocele and Dandy‐Walker malformation and modestly elevated estimates for several other defects. Bias‐adjusted estimates were similar to the main analysis.ConclusionFirst‐trimester antifungal use was positively associated with several birth defects in our analysis, although CIs were imprecise. Further study is warranted to investigate associations between antifungal use and birth defects, including potential bias due to confounding by indication.

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Evaluation of Association Between Oral and Topical Terbinafine Use in Pregnancy and Risk of Major Malformations and Spontaneous Abortion

Abstract: IMPORTANCETerbinafine is a commonly used antifungal agent, but safety data of its use in pregnancy are limited.OBJECTIVE To examine the association between oral and topical terbinafine exposure in pregnancy and the risk of major malformations and spontaneous abortion.

Cited by 17 publications

References 32 publications

The unprecedented epidemic-like scenario of dermatophytosis in India: III. Antifungal resistance and treatment options

The unprecedented epidemic-like scenario of dermatophytosis in India: III. Antifungal resistance and treatment options

Oral and Topical Terbinafine for Fungal Infections in Pregnancy

Antifungal medication use during pregnancy and the risk of selected major birth defects in the National Birth Defects Prevention Study, 1997–2011

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