Maternal Exposure to Amoxicillin and the Risk of Oral Clefts

Abstract

Background Prior studies have suggested an increased risk of oral clefts after exposure to amoxicillin in early pregnancy, but findings have been inconsistent. Methods Among participants in the Slone Epidemiology Center Birth Defects Study from 1994 to 2008, we identified 877 infants with cleft lip with/without cleft palate (CL/P) and 471 with cleft palate alone (CP). Controls included 6952 non-malformed infants. Mothers were interviewed about demographic, reproductive and medical factors, and details of medication use. We estimated odds ratios (ORs) and 95% confidence intervals (CIs) associated with use of amoxicillin in the first trimester using conditional logistic regression and adjusting for known risk factors for oral clefts, as well as for infections, fever, and concomitant treatments. Results In the control group, 3% of women had used amoxicillin in the first trimester. Maternal use of amoxicillin was associated with an increased risk of CL/P (adjusted OR= 2.0 [95% CI= 1.0–4.1]), with an OR of 4.3 (1.4–13.0) for third-gestational-month use. Risks were not elevated for use of other penicillins or cephalosporins. For CP, the OR for first-trimester amoxicillin was 1.0 (0.4–2.3), with an OR of 7.1 (1.4–36.4) for third-gestational-month use. Conclusions Amoxicillin use in early pregnancy may be associated with an increased risk of oral clefts.

Prophylaxis and Treatment of Anthrax in Pregnant Women

“…36, 56, 57, 59–61 A recent case-control study of 877 case infants with CL+/−CP found a higher rate of first trimester amoxicillin-exposure among mothers of case-infants (n=28) than among mothers of control-infants (OR=2.0, 95% CI 1.0–4.1). 54 A similar finding was seen in an earlier case-control study (n=1374 cases); a statistically significant association between amoxicillin exposure and CL+/−CP (n=7) was observed. The prevalence odds ratios were 15.9 (95% CI 4.9–51.2) when compared to population controls and 5.4 (95% CI 1.9–15.4) when compared to malformed controls.…”

“…Although recent reports indicate a possible association of amoxicillin with facial clefts, 54, 55 some of these results reach only borderline statistical significance. 54 In addition, if we assume a doubling of the risk 54 in the context of the estimated birth prevalence for CL+/−CP 146 , the absolute risk of orofacial clefts with exposure to amoxicillin would still be considered low.…”

“…30, 31, 36, 54–62 The large retrospective cohort by Cooper et al, included 14,534 amoxicillin-exposures, which showed no increased risk of major congenital anomalies, with exposure during the 1 st four lunar months (RR=1.09, 95% CI 0.86–1.37) or any time during pregnancy (RR=0.99, 95% CI 0.80–1.23). A non-statistically significant increased risk of orofacial clefts (RR=1.67, 95% CI 0.56–5.04) was observed with amoxicillin exposure in the 1 st 4 lunar months of pregnancy.…”

Bruk av antibiotika i svangerskapet

“…Den første, med over 1 300 pasienter, identifiserte en signifikant økt risiko for åpen leppe-gane-spalte etter bruk av amoksicillin i første trimester (OR = 2,0; 95 % KI 1,0 -4,1) og i tredje svangerskapsmåned (OR = 4,3; 95 % KI 1,4 -13,0) og en signifikant økt risiko for isolert ganespalte etter bruk av amoksicillin i tredje svangerskapsmåned (OR = 7,1; 95 % KI 1,4 -36) (18). Funnene var basert på 28 amoksicillineksponerte tilfeller av åpen leppe-gane spalte og 11 tilfeller av isolert ganespalte etter amoksicillineksponering i første trimester.…”

Treatment of Acne in Pregnancy

“…Its use in early pregnancy may increase the risk of oral clefts. 23 Amoxicillin can be used alone or in combination with other agents as an option for treatment-resistant acne. 24 It is associated with gastrointestinal side effects such as nausea and vomiting.…”