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Association between use of macrolides in pregnancy and risk of major birth defects: nationwide, register based cohort study

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@article{01010723ca6c4e5f90e7075b3c5c4232,
title = "Association between use of macrolides in pregnancy and risk of major birth defects: nationwide, register based cohort study",
abstract = "OBJECTIVE: To examine the association between the use of macrolide antibiotics in pregnancy and the risk of major birth defects.DESIGN: Nationwide, register based cohort study.SETTING: Denmark, 1997-2016.PARTICIPANTS: Of 1 192 539 live birth pregnancies, pregnancies during which macrolides had been used (13 019) were compared with those during which penicillin (that is, phenoxymethylpenicillin) had been used (matched in a 1:1 ratio on propensity scores). Other comparative groups were pregnancies when macrolides had been used recently but before pregnancy (matched 1:1) and pregnancies where no antibiotics had been used (matched 1:4).MAIN OUTCOME MEASURES: Association with an outcome of any major birth defect and specific subgroups of birth defects were assessed by relative risk ratios and absolute risk differences.RESULTS: In matched comparisons, 457 infants were born with major birth defects to women who had used macrolides during pregnancy (35.1 per 1000 pregnancies) compared with 481 infants (37.0 per 1000 pregnancies) to women who had used penicillin (relative risk ratio 0.95; 95% confidence interval 0.84 to 1.08), corresponding to an absolute risk difference of -1.8 (95% confidence interval -6.4 to 2.7) per 1000 pregnancies. The risk of major birth defects was not significantly increased for women who had used macrolides during pregnancy compared with those who had used macrolides recently but before becoming pregnant (relative risk ratio 1.00 (95% confidence interval 0.88 to 1.14); absolute risk difference -0.1 (95% confidence interval -4.8 to 4.7) per 1000 pregnancies) or compared with women who did not use any antibiotics (1.05 (0.95 to 1.17); 1.8 (-1.7 to 5.3) per 1000 pregnancies). For all three comparative group analyses and in the analyses of use of individual macrolides, no significant increased risk of specific subgroups of birth defects associated with the use of macrolides was found.CONCLUSIONS: In this nationwide cohort study, the use of macrolide antibiotics in pregnancy was not associated with an increased risk of major birth defects. Analyses of the associated risk of 12 specific subgroups of birth defects with the use of macrolides in pregnancy were not significant.",
keywords = "Abnormalities, Drug-Induced/epidemiology, Adult, Anti-Bacterial Agents/therapeutic use, Case-Control Studies, Cohort Studies, Female, Gestational Age, Humans, Infant, Newborn, Macrolides/therapeutic use, Penicillin V/therapeutic use, Practice Patterns, Physicians'/statistics & numerical data, Pregnancy, Propensity Score, Registries",
author = "Andersson, {Niklas Worm} and Olsen, {Rasmus Huan} and Andersen, {Jon Tr{\ae}rup}",
note = "{\textcopyright} Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2021",
month = feb,
day = "10",
doi = "10.1136/bmj.n107",
language = "English",
volume = "372",
pages = "n107",
journal = "BMJ",
issn = "1756-1833",
publisher = "B M J Group",

}

RIS

TY - JOUR

T1 - Association between use of macrolides in pregnancy and risk of major birth defects

T2 - nationwide, register based cohort study

AU - Andersson, Niklas Worm

AU - Olsen, Rasmus Huan

AU - Andersen, Jon Trærup

N1 - © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2021/2/10

Y1 - 2021/2/10

N2 - OBJECTIVE: To examine the association between the use of macrolide antibiotics in pregnancy and the risk of major birth defects.DESIGN: Nationwide, register based cohort study.SETTING: Denmark, 1997-2016.PARTICIPANTS: Of 1 192 539 live birth pregnancies, pregnancies during which macrolides had been used (13 019) were compared with those during which penicillin (that is, phenoxymethylpenicillin) had been used (matched in a 1:1 ratio on propensity scores). Other comparative groups were pregnancies when macrolides had been used recently but before pregnancy (matched 1:1) and pregnancies where no antibiotics had been used (matched 1:4).MAIN OUTCOME MEASURES: Association with an outcome of any major birth defect and specific subgroups of birth defects were assessed by relative risk ratios and absolute risk differences.RESULTS: In matched comparisons, 457 infants were born with major birth defects to women who had used macrolides during pregnancy (35.1 per 1000 pregnancies) compared with 481 infants (37.0 per 1000 pregnancies) to women who had used penicillin (relative risk ratio 0.95; 95% confidence interval 0.84 to 1.08), corresponding to an absolute risk difference of -1.8 (95% confidence interval -6.4 to 2.7) per 1000 pregnancies. The risk of major birth defects was not significantly increased for women who had used macrolides during pregnancy compared with those who had used macrolides recently but before becoming pregnant (relative risk ratio 1.00 (95% confidence interval 0.88 to 1.14); absolute risk difference -0.1 (95% confidence interval -4.8 to 4.7) per 1000 pregnancies) or compared with women who did not use any antibiotics (1.05 (0.95 to 1.17); 1.8 (-1.7 to 5.3) per 1000 pregnancies). For all three comparative group analyses and in the analyses of use of individual macrolides, no significant increased risk of specific subgroups of birth defects associated with the use of macrolides was found.CONCLUSIONS: In this nationwide cohort study, the use of macrolide antibiotics in pregnancy was not associated with an increased risk of major birth defects. Analyses of the associated risk of 12 specific subgroups of birth defects with the use of macrolides in pregnancy were not significant.

AB - OBJECTIVE: To examine the association between the use of macrolide antibiotics in pregnancy and the risk of major birth defects.DESIGN: Nationwide, register based cohort study.SETTING: Denmark, 1997-2016.PARTICIPANTS: Of 1 192 539 live birth pregnancies, pregnancies during which macrolides had been used (13 019) were compared with those during which penicillin (that is, phenoxymethylpenicillin) had been used (matched in a 1:1 ratio on propensity scores). Other comparative groups were pregnancies when macrolides had been used recently but before pregnancy (matched 1:1) and pregnancies where no antibiotics had been used (matched 1:4).MAIN OUTCOME MEASURES: Association with an outcome of any major birth defect and specific subgroups of birth defects were assessed by relative risk ratios and absolute risk differences.RESULTS: In matched comparisons, 457 infants were born with major birth defects to women who had used macrolides during pregnancy (35.1 per 1000 pregnancies) compared with 481 infants (37.0 per 1000 pregnancies) to women who had used penicillin (relative risk ratio 0.95; 95% confidence interval 0.84 to 1.08), corresponding to an absolute risk difference of -1.8 (95% confidence interval -6.4 to 2.7) per 1000 pregnancies. The risk of major birth defects was not significantly increased for women who had used macrolides during pregnancy compared with those who had used macrolides recently but before becoming pregnant (relative risk ratio 1.00 (95% confidence interval 0.88 to 1.14); absolute risk difference -0.1 (95% confidence interval -4.8 to 4.7) per 1000 pregnancies) or compared with women who did not use any antibiotics (1.05 (0.95 to 1.17); 1.8 (-1.7 to 5.3) per 1000 pregnancies). For all three comparative group analyses and in the analyses of use of individual macrolides, no significant increased risk of specific subgroups of birth defects associated with the use of macrolides was found.CONCLUSIONS: In this nationwide cohort study, the use of macrolide antibiotics in pregnancy was not associated with an increased risk of major birth defects. Analyses of the associated risk of 12 specific subgroups of birth defects with the use of macrolides in pregnancy were not significant.

KW - Abnormalities, Drug-Induced/epidemiology

KW - Adult

KW - Anti-Bacterial Agents/therapeutic use

KW - Case-Control Studies

KW - Cohort Studies

KW - Female

KW - Gestational Age

KW - Humans

KW - Infant, Newborn

KW - Macrolides/therapeutic use

KW - Penicillin V/therapeutic use

KW - Practice Patterns, Physicians'/statistics & numerical data

KW - Pregnancy

KW - Propensity Score

KW - Registries

UR - http://www.scopus.com/inward/record.url?scp=85100982950&partnerID=8YFLogxK

U2 - 10.1136/bmj.n107

DO - 10.1136/bmj.n107

M3 - Journal article

C2 - 33568349

VL - 372

SP - n107

JO - BMJ

JF - BMJ

SN - 1756-1833

M1 - n107

ER -

ID: 62270150