First‐trimester exposure to amoxycillin/clavulanic acid: a prospective, controlled study

Abstract

AimsThe number of published studies on the use of amoxycillin/clavulanic acid during pregnancy is small and so is the number of pregnancies investigated in those studies. In this study we wished to investigate prospectively the safety of intrauterine exposure to amoxycillin/clavulanic acid in a relatively large cohort of women. MethodsWomen treated ( n = 191) with amoxycillin/clavulanic acid during the first trimester of pregnancy were recruited from two teratogen information centres in Israel. Exposed women were matched for age, smoking habits and alcohol consumption with 191 controls exposed to amoxycillin only for similar medical indications. ResultsMaternal age, birth weight, gestational age at delivery, rates of live births and abortions were comparable between the two groups. Rates of major malformations in the amoxycillin/clavulanic acid group (3/158, 1.9%) did not differ significantly from controls (5/163, 3%) ( P = 0.49, relative risk = 0.62, 95% confidence interval 0.15, 2.55), and were within the expected baseline risk for the general population. ConclusionThese data suggest that exposure to amoxycillin/clavulanic acid during pregnancy is unlikely to be associated with an increased risk of malformations.

Pregnancy and Breastfeeding in Patients with Crohn’s Disease

“…In a population-based case-control study [32] and a prospective controlled study [33], amoxicillin/clavulanic acid has been shown not to increase the teratogenic risk and is considered compatible with breastfeeding. These studies were, however, not specifically designed for patients with Crohn’s disease in which antibiotic treatment is generally given for an extended duration.…”

Treatment of inflammatory bowel disease and pregnancy: a review of the literature

“…Tetracycline and sulfonamides are contraindicated in pregnancy (13) . Amoxicilin with or no clavulinic acid is compatible with breastfeeding and does not increase the risks for congenital anomalies (6) .…”

“…Ciprofloxacin and other quinolones have been used in pregnant women without evidence of congenital or musculoskeletal abnormalities in children and should be avoided its use in the first trimester (26) . However, more studies are needed to confirm (6) . Its use seems to be safe in breastfeeding (26) .…”

Enfermedad inflamatoria intestinal y gestación

“…En general, dada además la escasa evidencia que existe de beneficio en EII, debe evitarse durante el embarazo 36 . Cuando se necesita un antibiótico, una buena elección sería la amoxicilina-ácido clavulánico, que corresponde a la categoría B de la FDA y cuyo uso no se ha asociado a teratogenicidad 82,83 . c) Glucocorticoides…”

“…Los datos disponibles sobre la utilización de quinolonas en la lactancia materna son limitados, pero es probable que sean compatibles 8,80 . La seguridad de la rifaximina en la lactancia materna es desconocida 6 y, por último, la amoxicilina-ácido clavulánico es compatible con la lactancia 82,83 . c) Glucocorticoides…”