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Research and analysis

Annex 2: Table 2

Updated 28 June 2021
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Study Includes erythromycin, azithromycin or clarithromycin Includes outcome of interest (MCM, CVM or miscarriage) Comparator Included or excluded Reason for exclusion
Czeizel AE, Rockenbauer M, Sorensen HT, Olsen J. A Population based case–control teratologic study of oral erythromycin treatment during pregnancy. Reprod Toxicol. 1999;13(6):531–6. yes (erythromycin) any congenital malformation NA (case-control) Included N/A
Crider KS, Cleves MA, Reefhuis J, Berry RJ, Hobbs CA, Hu DJ. Antibacterial medication use during pregnancy and risk of birth defects: national birth defects prevention study. Arch Pediatr Adolesc Med. 2009;163(11):978–85. https ://doi.org/10.1001/archp ediat rics.2009.188. yes (erythromycin) MCM NA (case-control) Included N/A
Andersen JT, Petersen M, Jimenez‐Solem E, Broedbaek K, Andersen NL, Torp‐Pedersen C, et al. Clarithromycin in early pregnancy and the risk of miscarriage and malformation: a register based nationwide cohort study. PLoS One. 2013;8(1):e53327. https ://doi.org/10.1371/journ al.pone.00533 27. yes (clarithromycin) MCM, miscarriage (spontaneous abortion) unexposed women Included N/A
Lin KJ, Mitchell AA, Yau WP, Louik C, Hernandez‐Diaz S. Safety of macrolides during pregnancy. Am J Obstet Gynecol. 2013;208(3):221. https ://doi.org/10.1016/j.ajog.2012.12.023. yes (erythromycin) CVM NA (case-control) Included N/A
Kallen B, Danielsson BR. Fetal safety of erythromycin. An update of Swedish data. Eur J Clin Pharmacol. 2014;70(3):355–60. https://doi.org/10.1007/s0022 8‐013‐1624‐3. yes (erythromycin) CVM unexposed women Included N/A
Wilton LV, Pearce GL, Martin RM, Mackay FJ, Mann RD. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol. 1998;105(8):882–9. yes (azithromycin) stillbirths, abortions (missed, spontaneous, therapeutic), intaruterine death, ectopic pregnancy, congenital malformations N/A excluded no outcomes of interest reported for azithromycin
Czeizel AE, Rockenbauer M, Olsen J, Sorensen HT. A case–control teratological study of spiramycin, roxithromycin, oleandomycin and josamycin. Acta Obstet Gynecol Scand. 2000;79(3):234–7. no MCM N/A excluded did not study macrolide of interest
Mahon BE, Rosenman MB, Kleiman MB. Maternal and infant use of erythromycin and other macrolide antibiotics as risk factors for infantile hypertrophic pyloric stenosis. J Pediatr. 2001;139(3):380–4. https//doi.org/10.1067/mpd.2001.11757 7. yes (all 3 macrolides) no (pyloric stenosis) unexposed women excluded did notstudy outcome of interest
Cooper WO, Griffin MR, Arbogast P, Hickson GB, Gautam S, Ray WA. Very early exposure to erythromycin and infantile hypertrophic pyloric stenosis. Arch Pediatr Adolesc Med. 2002;156(7):647–50. https ://doi.org/10.1001/archpe di.156.7.647. yes (erythromycin) no (pyloric stenosis) other antibiotics excluded did not study outcome of interest
Louik C, Werler MM, Mitchell AA. Erythromycin use during pregnancy in relation to pyloric stenosis. Am J Obstet Gynecol. 2002;186(2):288– 90. https ://doi.org/10.1067/mob.2002.11971 8. yes (erythromycin) no (pyloric stenosis) N/A (case-control) excluded did not study outcome of interest
Wolfgang P, Schloemp S, Sterzik K, Stoz F, editors. Does roxithromycin affect embryo development? 33rd Annual Conference of the European Teratology Society; 3–7 Sep, 2005; Haarlem, The Netherlands: Reproductive Toxicology. no all congenital malformations, miscarriage unexposed women excluded did not study macrolide of interest
Chun JY, Han JY, Ahn HK, Choi JS, Koong MK, Nava‐Ocampo AA, et al. Fetal outcome following roxithromycin exposure in early pregnancy. J Matern Fetal Neonatal Med. 2006;19(3):189–92. https ://doi.org/10.1080/14767 05050 04396 57. no congenital malformations unexposed women excluded did not study macrolide of interest
Bar‐Oz B, Diav‐Citrin O, Shechtman S, Tellem R, Arnon J, Francetic I, et al. Pregnancy outcome after gestational exposure to the new macrolides: a prospective multi‐center observational study. Eur J Obstet Gynecol Reprod Biol. 2008;141(1):31–4. https ://doi.org/10.1016/j.ejogr b.2008.07.008. yes (azithromycin, clarithromycin) MCM, spontaneous abortions women exposed to other antibiotics or other non teratogenic drug excluded mixed comparator groups
Sarkar M, Woodland C, Koren G, Einarson AR. Pregnancy outcome following gestational exposure to azithromycin. BMC Pregnancy Childbirth. 2006;6:18. https ://doi.org/10.1186/1471‐2393‐6‐18. yes (azithromycin) MCM, spontaneous abortions women exposed to nonteratogenic antibiotics for similar indications or nonteratogens excluded mixed comparator groups, only event rates presented
Bar‐Oz B, Weber‐Schoendorfer C, Berlin M, Clementi M, Di Gianantonio E, de Vries L, et al. The outcomes of pregnancy in women exposed to the new macrolides in the first trimester:a prospective, multicentre, observational study. Drug Saf. 2012;35(7):589–98. https ://doi.org/10.2165/11630 920‐000000000‐ 00000 yes (azithromycin, clarithromycin) congenital malformations women exposed to nonteratogens excluded mixed comparator group
Dinur AB, Koren G, Matok I, Wiznitzer A, Uziel E, Gorodischer R, et al. Fetal safety of macrolides. Antimicrob Agents Chemother. 2013;57(7):3307–11. https ://doi.org/10.1128/AAC.01691‐12. yes (erythromycin, azithromycin and clarithromycin) MCM unexposed women excluded no individual analysis per macrolide