Exposure to Macrolides During Pregnancy and the Risk for Spontaneous Abortions: A Population-Based Retrospective Cohort Study.
drug safety
drugs in pregnancy
macrolides
spontaneous abortion
Journal
Journal of clinical pharmacology
ISSN: 1552-4604
Titre abrégé: J Clin Pharmacol
Pays: England
ID NLM: 0366372
Informations de publication
Date de publication:
28 May 2024
28 May 2024
Historique:
received:
01
06
2023
accepted:
20
04
2024
medline:
28
5
2024
pubmed:
28
5
2024
entrez:
28
5
2024
Statut:
aheadofprint
Résumé
Previous studies evaluating the risk of spontaneous abortions following exposure to macrolides reported controversial results. The goal of the current study was to examine the risk for spontaneous abortions following exposure to macrolides during pregnancy. We conducted a population-based retrospective cohort study by linking three computerized databases: Clalit Health Services drug dispensation database, Soroka Medical Center (SMC) birth database, and SMC hospitalizations database. Multivariate time-varying Cox regressions were performed and adjusted for suspected confounders and known risk factors for spontaneous abortions. Hazard ratios (HR) and 95% confidence intervals (CI) were calculated. A secondary analysis was performed to assess the association between exposure to macrolides in terms of the defined daily dose dispensed and spontaneous abortions. The study cohort included 65,457 pregnancies that ended at Soroka Medical Center between 2004 and 2009, of which 6508 (9.9%) resulted in a spontaneous abortion. A total of 825 (1.26%) pregnancies were exposed to macrolides during the exposure period. Exposure to macrolides was not associated with spontaneous abortions as a group (adjusted HR 1.00 95% CI 0.77-1.31) or as specific medications. There was no evidence of a dose-response relationship between exposure to macrolides and spontaneous abortions. In conclusion, this population-based retrospective cohort study did not detect an increased risk for spontaneous abortion following exposure to macrolides during the first trimester of pregnancy.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024, The American College of Clinical Pharmacology.
Références
Bahat Dinur A, Koren G, Matok I, et al. Fetal safety of macrolides. Antimicrob Agents Chemother. 2013;57(7):3307‐3311. doi:10.1128/AAC.01691‐12
Brunton LL, Chabner BA, Knollmann BC. Chapter 55 Protein synthesis inhibitors and miscellaneous antibacterial agents. In: Goodman & Gilman's The Pharmacological Basis of Therapeutics. 12th ed. McGraw Hill; 2011.
Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community‐acquired pneumonia in adults. Clin Infect Dis Off Publ Infect Dis Soc Am. 2007;44 Suppl 2(Journal Article):27.
Jelic D, Antolovic R. From erythromycin to azithromycin and new potential ribosome‐binding antimicrobials. Antibiot Basel Switz. 2016;5(3):29. doi:10.3390/antibiotics5030029
Tozzi AE, Celentano LP, Ciofi degli Atti ML, Salmaso S. Diagnosis and management of pertussis. CMAJ Can Med Assoc J J Assoc Medicale Can. 2005;172(4):509‐515.
Murchison L, De Coppi P, Eaton S. Post‐natal erythromycin exposure and risk of infantile hypertrophic pyloric stenosis: a systematic review and meta‐analysis. Pediatr Surg Int. 2016;32(12):1147‐1152. doi:10.1007/s00383‐016‐3971‐5
Windfuhr JP, Toepfner N, Steffen G, Waldfahrer F, Berner R. Clinical practice guideline: tonsillitis I. Diagnostics and nonsurgical management. Eur Arch Oto‐Rhino‐Laryngol Off J Eur Fed Oto‐Rhino‐Laryngol Soc EUFOS Affil Ger Soc Oto‐Rhino‐Laryngol ‐ Head Neck Surg. 2016;273(4):973‐987. doi:10.1007/s00405‐015‐3872‐6
Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. Chapter 192: Infections due to Campylobacter and related organisms. In: Harrison's Principles of Internal Medicine. 19th ed. McGraw Hill; 2014.
Prernoll M, Benson R. Chapter 14 : Early pregnancy risks. In: Current Diagnosis & Treatment, Obstetrics & Gynecology. 10th ed. McGraw‐Hill; 2007.
Harlap S, Shiono PH. Alcohol, smoking, and incidence of spontaneous abortions in the first and second trimester. Lancet Lond Engl. 1980;2(8187):173‐176.
Wang X, Chen C, Wang L, Chen D, Guang W, French J. Conception, early pregnancy loss, and time to clinical pregnancy: a population‐based prospective study. Fertil Steril. 2003;79(3):577‐584.
Wilcox AJ, Weinberg CR, O'Connor JF, et al. Incidence of early loss of pregnancy. N Engl J Med. 1988;319(4):189‐194. doi:10.1056/NEJM198807283190401
Nybo Andersen AM, Wohlfahrt J, Christens P, Olsen J, Melbye M. Maternal age and fetal loss: population based register linkage study. BMJ. 2000;320(7251):1708‐1712.
Pritts EA, Parker WH, Olive DL. Fibroids and infertility: an updated systematic review of the evidence. Fertil Steril. 2009;91(4):1215‐1223. doi:10.1016/j.fertnstert.2008.01.051
Klatsky PC, Tran ND, Caughey AB, Fujimoto VY. Fibroids and reproductive outcomes: a systematic literature review from conception to delivery. Am J Obstet Gynecol. 2008;198(4):357‐366. doi:10.1016/j.ajog.2007.12.039
Salim R, Regan L, Woelfer B, Backos M, Jurkovic D. A comparative study of the morphology of congenital uterine anomalies in women with and without a history of recurrent first trimester miscarriage. Hum Reprod Oxf Engl. 2003;18(1):162‐166.
Mills JL, Simpson JL, Driscoll SG, et al. Incidence of spontaneous abortion among normal women and insulin‐dependent diabetic women whose pregnancies were identified within 21 days of conception. N Engl J Med. 1988;319(25):1617‐1623. doi:10.1056/NEJM198812223192501
Abalovich M, Gutierrez S, Alcaraz G, Maccallini G, Garcia A, Levalle O. Overt and subclinical hypothyroidism complicating pregnancy. Thyroid Off J Am Thyroid Assoc. 2002;12(1):63‐68. doi:10.1089/105072502753451986
Clifford K, Rai R, Watson H, Franks S, Regan L. Does suppressing luteinising hormone secretion reduce the miscarriage rate? Results of a randomised controlled trial. BMJ. 1996;312(7045):1508‐1511.
Robertson L, Wu O, Langhorne P, et al. Thrombophilia in pregnancy: a systematic review. Br J Haematol. 2006;132(2):171‐196.
Branch DW, Khamashta MA. Antiphospholipid syndrome: obstetric diagnosis, management, and controversies. Obstet Gynecol. 2003;101(6):1333‐1344.
ESHRE Capri Workshop Group. Nutrition and reproduction in women. Hum Reprod Update. 2006;12(3):193‐207.
Mishra GD, Dobson AJ, Schofield MJ. Cigarette smoking, menstrual symptoms and miscarriage among young women. Aust N Z J Public Health. 2000;24(4):413‐420.
Henriksen TB, Hjollund NH, Jensen TK, et al. Alcohol consumption at the time of conception and spontaneous abortion. Am J Epidemiol. 2004;160(7):661‐667. doi:10.1093/aje/kwh259
Weng X, Odouli R, Li DK. Maternal caffeine consumption during pregnancy and the risk of miscarriage: a prospective cohort study. Am J Obstet Gynecol. 2008;198(3):279.e1‐279.e8. doi:10.1016/j.ajog.2007.10.803
Er A. Azithromycin prevents pregnancy loss: reducing the level of tumor necrosis factor‐alpha and raising the level of interleukin‐10 in rats. Mediators Inflamm. 2013;2013:928137. doi:10.1155/2013/928137
Einarson A, Phillips E, Mawji F, et al. A prospective controlled multicentre study of clarithromycin in pregnancy. Am J Perinatol. 1998;15(9):523‐525. doi:10.1055/s‐2007‐994053
Andersen JT, Petersen M, Jimenez‐Solem E, 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. doi:10.1371/journal.pone.0053327
Muanda FT, Sheehy O, Berard A. Use of antibiotics during pregnancy and risk of spontaneous abortion. CMAJ Can Med Assoc J J Assoc Medicale Can. 2017;189(17):E625‐E633. doi:10.1503/cmaj.161020
Omranipoor A, Kashanian M, Dehghani M, Sadeghi M, Baradaran HR. Association of antibiotics therapy during pregnancy with spontaneous miscarriage: a systematic review and meta‐analysis. Arch Gynecol Obstet. 2020;302(1):5‐22. doi:10.1007/s00404‐020‐05569‐4
Abdellatif M, Ghozy S, Kamel MG, et al. Association between exposure to macrolides and the development of infantile hypertrophic pyloric stenosis: a systematic review and meta‐analysis. Eur J Pediatr. 2019;178(3):301‐314. doi:10.1007/s00431‐018‐3287‐7
Angel D. Patterns of fertility in 2006 (article in Hebrew). 2007;2024(12/18). https://www.cbs.gov.il/he/mediarelease/DocLib/2007/215/01_07_215b.pdf
Damari N. National Insurance Institute of Israel, periodic survey [article in Hebrew]. 2021; 2024. https://www.btl.gov.il/Publications/survey/Documents/320/seker_320.pdf
Daniel S, Koren G, Lunenfeld E, Levy A. Immortal time bias in drug safety cohort studies: spontaneous abortion following nonsteroidal antiinflammatory drug exposure. Am J Obstet Gynecol. 2015;212(3):307.e1‐307.e6. doi:10.1016/j.ajog.2014.09.028
Suissa S. Immortal time bias in pharmaco‐epidemiology. Am J Epidemiol. 2008;167(4):492‐499.
Lanas A, Polo‐Tomas M, Roncales P, Gonzalez MA, Zapardiel J. Prescription of and adherence to non‐steroidal anti‐inflammatory drugs and gastroprotective agents in at‐risk gastrointestinal patients. Am J Gastroenterol. 2012;107(5):707‐714. doi:10.1038/ajg.2012.13
Ray WA, Griffin MR. Use of Medicaid data for pharmacoepidemiology. Am J Epidemiol. 1989;129(4):837‐849.
West SL, Savitz DA, Koch G, Strom BL, Guess HA, Hartzema A. Recall accuracy for prescription medications: self‐report compared with database information. Am J Epidemiol. 1995;142(10):1103‐1112.
Johnson RE, Vollmer WM. Comparing sources of drug data about the elderly. J Am Geriatr Soc. 1991;39(11):1079‐1084.