Risk of fetal malformation, spontaneous abortion, and adverse pregnancy outcomes after gestational terbinafine exposure: a systematic review. 2022

Philipp Foessleitner, and Alex Farr, and Julia Deinsberger
Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria.

Fungal skin and nail infections are common health issues affecting an estimated 10%-20% of the world's population. The antifungal agent terbinafine shows broad-spectrum activity against a wide range of fungal species and is commonly prescribed as a first-line treatment for dermatomycoses and onychomycoses. However, owing to insufficient data regarding embryotoxicity and adverse pregnancy outcomes, treatment with terbinafine is currently not recommended in pregnancy and breastfeeding. This systematic review aimed to evaluate the effects of gestational terbinafine exposure on congenital malformations, spontaneous abortions, and adverse pregnancy outcomes. PubMed/MEDLINE, EMBASE, and clinicaltrials.org were searched to retrieve relevant reports up to March 2022. Two investigators independently screened the articles, extracted the data, and performed a quality assessment using the Newcastle-Ottawa Scale. Two cohort and two case-control studies were eligible for inclusion. Overall, the study showed the absence of an increased risk of congenital malformations, spontaneous abortion, preterm birth, small for gestational age, low birth weight, or stillbirth, following systemic or topical terbinafine exposure during pregnancy. In conclusion, the use of systemic and topical terbinafine during pregnancy can be regarded as safe for mothers and unborn children. The current recommendation concerning gestational terbinafine administration should be reconsidered.

UI MeSH Term Description Entries
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D011247 Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. Gestation,Pregnancies
D011256 Pregnancy Outcome Results of conception and ensuing pregnancy, including LIVE BIRTH; STILLBIRTH; or SPONTANEOUS ABORTION. The outcome may follow natural or artificial insemination or any of the various ASSISTED REPRODUCTIVE TECHNIQUES, such as EMBRYO TRANSFER or FERTILIZATION IN VITRO. Outcome, Pregnancy,Outcomes, Pregnancy,Pregnancy Outcomes
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000022 Abortion, Spontaneous Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference. Abortion, Tubal,Early Pregnancy Loss,Miscarriage,Spontaneous Abortion,Abortions, Spontaneous,Abortions, Tubal,Early Pregnancy Losses,Loss, Early Pregnancy,Losses, Early Pregnancy,Miscarriages,Pregnancy Loss, Early,Pregnancy Losses, Early,Spontaneous Abortions,Tubal Abortion,Tubal Abortions
D000077291 Terbinafine A naphthalene derivative that inhibits fungal SQUALENE EPOXIDASE and is used to treat DERMATOMYCOSES of the skin and nails. (E)-N-(6,6-Dimethyl-2-heptenynyl)-N-methyl-1-naphthalenementhamin hydrochloride,DA 5505,Lamisil,SF 86-327,SF-86-327,TDT-067,Terbinafine Hydrochloride,Terbinafine, (Z)-,Terbinafine, (Z)-isomer,SF 86 327,SF 86327,SF86327,TDT 067,TDT067
D000935 Antifungal Agents Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. Anti-Fungal Agents,Antifungal Agent,Fungicides, Therapeutic,Antibiotics, Antifungal,Therapeutic Fungicides,Agent, Antifungal,Anti Fungal Agents,Antifungal Antibiotics
D047928 Premature Birth CHILDBIRTH before 37 weeks of PREGNANCY (259 days from the first day of the mother's last menstrual period, or 245 days after FERTILIZATION). Preterm Birth,Birth, Premature,Birth, Preterm,Births, Premature,Births, Preterm,Premature Births,Preterm Births

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