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 |