Metronidazole (Flagyl®)

Selected References:

  • Ajiji P, et al. 2021. Investigating the efficacy and safety of metronidazole during pregnancy; A systematic review and meta-analysis. European Journal of Obstetrics & Gynecology and Reproductive Biology: X11, 100128.
  • Burtin P, et al. 1995. Safety of metronidazole in pregnancy: a meta-analysis. Am J Obstet Gynecol 172(21):525-529.
  • Cantu JM & Garcia-Cruz D. 1982. Midline facial defect as a teratogenic effect of metronidazole. Birth Defects 18:85-88.
  • Caro-Paton T, et al. 1997. Is metronidazole teratogenic? A meta-analysis. Br J Clin Pharmacol 44:(2)179-182.
  • Cram LF, et al. 2015. Genitourinary infections and their association with preterm labor. American Family Physician; 65(2), 241–249.
  • Czeizel AE & Rockenbauer M. 1998. A population-based case-control teratologic study of oral metronidazole. Br J Obstet Gynecol; 105(3):322-327.
  • Finegold SM. 1980. Metronidazole. Ann Intern Med 93:585-587.
  • Flagyl® Prescribing Information. Available online at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020334s015lbl.pdf.
  • Gilbert NM, et al. 2013. Urinary tract infection as a preventable cause of pregnancy complications: Opportunities, challenges, and a global call to action. Global Advances in Health and Medicine; 2(5), 59–69.
  • Gray MS, et al. 1961. Further observations on metronidazole (Flagyl). Br J Vener Dis; 37:278-9.
  • Heisterberg L, Branebjerg PE. 1983. Blood and milk concentrations of metronidazole in mothers and infants. J Perinat Med; 11:114-20.
  • Kazy Z, et al. 2005. Teratogenic potential of vaginal metronidazole treatment during pregnancy. Eur J Obstet Gynecol Reprod Biol. 123(2):174-178.
  • Koss CA, et al. 2012. Investigation of Metronidazole Use during Pregnancy and Adverse Birth Outcomes. Antimicrob Agents Chemother 56(9): 4800–4805.
  • Löfmark S, et al. 2010. Metronidazole is still the drug of choice for treatment of anaerobic infections. Clinical Infectious Diseases, 50(S1), S16–S23.
  • Muanda FT, et al. 2017. Use of antibiotics during pregnancy and risk of spontaneous abortion. CMAJ. 189(17):E625-E633.
  • Nwosu OC, Bloom K. The safety of metronidazole in pregnancy. Health Care Women Int. 2021;42(4-6):726-738.
  • Omranipoor A et al. 2020. Association of antibiotics therapy during pregnancy with spontaneous miscarriage: a systematic review and meta-analysis. Archives of Gynecology and Obstetrics302: 5-22.
  • Passmore CM, et al. 1988. Metronidazole excretion in human breastmilk and its effect on suckling neonates. British J Clin Pharmacol 26(1):45-51.
  • Piper JM, et al. 1993. Prenatal use of metronidazole and birth defects: no association. Obstet Gynecol 82(3):348-352.
  • Rosa FW, et al. 1987. Pregnancy outcomes after first trimester vaginitis drug therapy. Obstet Gynecol 69:751-755.
  • Sheehy O, et al. 2015. The use of metronidazole during pregnancy: a review of evidence. Curr Drug Saf. 10(2):170-9.
  • Workowski KA, Bolan GA. 2015. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep; 64:1-137.


Metronidazole (Flagyl®)

Selected References:

  • Anderson PO. 2021. Monoclonal antibodies during breastfeeding. Breastfeeding Medicine16(8): 591-93.
  • Noseda R, et al. 2024. Safety of Monoclonal Antibodies Inhibiting PCSK9 in Pregnancy: Disproportionality Analysis in VigiBase®. Clinical pharmacology and therapeutics, 10.1002/cpt.3269. Advance online publication.
  • Praluent® Prescribing Information. Available online at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125559Orig1s000lbledt.pdf, Accessed May 28, 2024
  • Vuignier Y, et al. 2021. Exposure to alirocumab during the first trimester of pregnancy: A case report. Birth Defects Research. 113(15): 1156–60.


Metronidazole (Flagyl®)

Selected References:

  • Anderson PO. 2021. Monoclonal antibodies during breastfeeding. Breastfeeding Medicine16(8): 591-93.
  • Dernoncourt A., et al. 2023. Fetal and Neonatal Adverse Drug Reactions Associated with Biologics Taken During Pregnancy by Women with Autoimmune Diseases: Insights from an Analysis of the World Health Organization Pharmacovigilance Database (VigiBase®). BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 37(1), 73–87.
  • Kimball AB. 2020. Pregnancy outcomes in women exposed to guselkumab: Experience from the clinical development program. J Am Acad Dermatol. 83(6):AB27.
  • McMullan P et al. 2024. Safety of dermatologic medications in pregnancy and lactation: An Update-Part I: Pregnancy. Journal of the American Academy of Dermatology.
  • Tremfya® Prescribing Information. Available online at http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf. Accessed on May 28, 2024.
  • Wolfe C et al., 2024. A Retrospective Review of Pregnancies in our Psoriasis Biologics Cohort. Clinical and Experimental Dermatology. llae106.


Metronidazole (Flagyl®)

Selected References:

  • Biocon Biologics Inc. 2023. Semglee Product Label. National Institute of Health DailyMed database. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?. Accessed 1 April 2024.
  • Bruttomesso D, et al. 2011. Type 1 diabetes control and pregnancy outcomes in women treated with continuous subcutaneous insulin infusion (CSII) or with insulin glargine and multiple daily injections of rapid-acting insulin analogues (glargine-MDI). Diabetes Metab. 37(5):426-431.
  • Callesen NF, et al. 2013. Treatment with the long-acting insulin analogues detemir or glargine during pregnancy in women with type 1 diabetes: comparison of glycaemic control and pregnancy outcome. J Matern Fetal Neonatal Med. 26(6):588-592.
  • Chico A, et al. 2016. Glycemic control and maternal and fetal outcomes in pregnant women with type 1 diabetes according to the type of basal insulin. Eur J Obstet Gynecol Reprod Biol 206: 84-91.
  • de Jong J, et al. 2016. Insulin analogues in pregnancy and specific congenital anomalies: a literature review. Diabetes Metab Res Rev 32(4): 366-375.
  • Di Cianni G, et al. 2005. Use of insulin glargine during the first weeks of pregnancy in five type 1 diabetic women. Diabetes Care 28:982-983.
  • Di Cianni G, et al. 2008. Perinatal outcomes associated with the use of glargine during pregnancy. Diabet Med. 25(8):993-996.
  • Dolci M, et al. 2005. Use of glargine insulin before and during pregnancy in a woman with type 1 diabetes and Addison’s Disease. Diabetes Care 28:2084-2085.
  • Eli Lilly and Company. 2023. Basaglar Product Label. National Institute of Health DailyMed database. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?. Accessed 1 April 2024.
  • Gallen IW, et al. 2008. Survey of glargine use in 115 pregnant women with Type 1 diabetes. Diabet Med. 25(2):165-169.
  • Holstein A, et al. 2003. Use of insulin glargine during embryogenesis in a pregnant woman with type 1 diabetes. Diabet Med 20:779-780.
  • Imbergamo MP, et al. 2008. Use of glargine in pregnant women with type 1 diabetes mellitus: a case-control study. Clin Ther. 30(8):1476-1484.
  • Lapolla A, et al. 2005. Insulin therapy in pregnancy complicated by diabetes: are insulin analogs a new tool? Diabetes Metab Res Rev 21:241-52.
  • Lepercq J, et al. 2010. Use of insulin glargine throughout pregnancy in 102 women with type 1 diabetes. Diabetes Metab. 36(3):209-212.
  • Negrato CA, et al. 2010. Glargine vs. NPH insulin therapy in pregnancies complicated by diabetes: an observational cohort study. Diabetes Res Clin Pract. 89(1):46-51.
  • Pantalone KM, et al. 2011. Glargine vs. NPH insulin therapy in pregnancies complicated by diabetes: an observational cohort study–comment on Negrato et al. Diabetes Res Clin Pract. 93(1):e9-10.
  • Pantalone KM, et al. 2011. Insulin glargine use during pregnancy. Endocr Pract. 17(3):448-55.
  • Pollex E, et al. 2011. Safety of insulin glargine use in pregnancy: a systematic review and meta-analysis. Ann Pharmacother. 45(1):9-16.
  • Price N, et al. 2007. Use of insulin glargine during pregnancy: a case-control pilot study. BJOG. 114(4):453-457.
  • Sanofi-Aventis U.S. 2022. Lantus Product Label. National Institute of Health DailyMed database. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?. Accessed 1 April 2024.
  • Sonfi-Aventus U.S. 2023. Toujeo Product Label. National Institute of Health DailyMed database. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?. Accessed 1 April 2024.
  • Torlone E, et al. 2007. Successful use of insulin glargine during entire pregnancy until delivery in six Type 1 diabetic women. Eur J Obstet Gynecol Reprod Biol. 132(2):238-239.
  • Woolderink JM, et al. 2005. Use of insulin glargine during pregnancy in seven type 1 diabetic women. Diabetes Care 28:2594-2595.


Metronidazole (Flagyl®)

Selected References

  • Anghelescu I, et al. 2004. Successful switch to aripiprazole after induction of hyperprolactinemia by ziprasidone: a case report. J Clin Psychiatry 65:1286-1287.
  • Biesdorf C, et al. 2019. Physiologically-based pharmacokinetics of ziprasidone in pregnant women. Br J Clin Pharmacol 85(5):914-923.
  • Bode’n R, et al. 2012. Antipsychotics During Pregnancy Relation to Fetal and Maternal Metabolic Effects. Arch Gen Psychiatry 69(7):715-721.
  • Creeley CE, et al. 2019. Use of Prescribed Psychotropics during Pregnancy: A Systematic Review of Pregnancy, Neonatal, and Childhood Outcomes. Brain Sci. 9(9), 235. https://doi.org/10.3390/brainsci9090235
  • Damkier P, Videbech P. 2018. The safety of second-generation antipsychotics during pregnancy: A clinically focused review. CNS Drugs. 32(4):351-366.
  • Einarson A, Boskovic R. 2009. Use and safety of antipsychotic drugs during pregnancy. J Psychiatr Pract 15(3):183-192.
  • FDA. 2011. Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns (issued 2/2011). https://www.fda.gov/Drugs/DrugSafety/ucm243903.htm
  • FDA 2014. Drug Safety Communication: FDA reporting mental health drug ziprasidone (Geodon) associated with rare but potentially fatal skin reactions. (Issued 12/2014). https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-reporting-mental-health-drug-ziprasidone-geodon-associated-rare#:~:text=Ziprasidone%20is%20marketed%20under%20the%20brand%20name%20Geodon%2C%20and%20as%20generics.
  • Ginsberg DL. 2003. Ziprasidone-induced galactorrhea. Prim Psychiatry 10:22-23.
  • Ginsbery DL. 2004. Ziprasidone-induced hyperprolactinemia. Prim Psychiatry 11:26–27.
  • Goodnick PJ, et al. 2002. Antipsychotics: Impact on prolactin levels. Expert Opin Pharmacother 3:1381–1391.
  • Haddad PM, Wieck A. 2004. Antipsychotic-induced hyperprolactinaemia: mechanisms, clinical features and management. Drugs 64:2291-2314.
  • Heinonen E, et al. 2022. Antipsychotic Use During Pregnancy and Risk for Gestational Diabetes: A National Register-Based Cohort Study in Sweden. CNS drugs 36(5):529–539.
  • Humby T, Davies W. 2019. Brain gene expression in a novel mouse model of postpartum mood disorder. Trans Neurosci 10:168-174.
  • Huybrechts KF, et al. 2016. Antipsychotic use in pregnancy and the risk for congenital malformations. JAMA Psychiatr 73(9):938-46.
  • Huybrechts KF, et al. 2023. Association of In Utero Antipsychotic Medication Exposure With Risk of Congenital Malformations in Nordic Countries and the US. JAMA psychiatry 80(2):156–166.
  • Jordan MP. 2003. Ziprasidone-associated galactorrhea in a female teenager. J Am Acad Child Adolesc Psychiatry 42:4-5.
  • Khan SJ, et al. 2016. Bipolar disorder in pregnancy and postpartum: Principles of management. Curr Psychiatry Rep; 18(2):13.
  • Kopecek M, et al. 2005. Ziprasidone-induced galactorrhea: A case report. Neuro Endocrinol Lett 26:69–70.
  • Kulkarni J, et al. 2015. Antipsychotic use in pregnancy. Expert Opin Pharmacother 16(9):1335-1345.
  • Lusskin SI, et al. 2004. Prolactin Elevation with Ziprasidone. American Journal of Psychiatry 161(10): 1925.
  • Maguire GA. 2002. Prolactin elevation with antipsychotic Medications: Mechanisms of action and clinical consequences. J Clin Psychiatry 63 Suppl 4:56–62.
  • McCauley-Elsom K, et al. 2010. Antipsychotics in pregnancy. Psychiat Ment Health Nurs 17(2):97-104.
  • Myers WT. 2014. A lacting adolescent on atypical antipsychotics: A case report of an emerging challenge. J Investig Med 62:485.
  • Park Y, et al. 2018. Continuation of atypical antipsychotic medication during early pregnancy and the risk of gestational diabetes. Am J Psychiatry 175(6):564-574
  • Peitl MV, et al. 2010. Ziprasidone as a possible cause of cleft palate in a newborn. Psychiatr Danub 22(1):117-119.
  • Ramadan M, et al. 2005. D2-blockade and possible ziprasidone-induced galactorrhea. Int Clin Psychopharmacol 20:113–114.
  • Raza S, Haq F. 2010. Ziprasidone-induced galactorrhea in an adolescent female: A case report. Prim Care Companion J Clin Psych 12.
  • Ruzic K, et al. 2009. Pregnancy and atypical antipsychotics. Psychiatr Danub 21(3):368-370.
  • Saldaña SN, Delgado SV. 2007. Ziprasidone-associated galactorrhea in an adolescent female. J Child Adolesc Psychopharmacol 17:259–260.
  • Schlotterbeck P, et al. 2009. Low concentration of ziprasidone in human milk: a case report. Int J Neuropsychopharmacology. 12(3) 437–438. https://doi.org/10.1017/S1461145709009936
  • Sørensen MJ, et al. 2015. Risk of fetal death after treatment with antipsychotic medications during pregnancy. PLoS One 10(7):e0132280.
  • Werremeyer A. 2009. Ziprasidone and citalopram use in pregnancy and lactation in a woman with psychotic depression. Am J Psychiatry 166(11):1298.
  • Uguz F. 2016. Second-generation antipsychotics during the lactation period: A comparative systematic review on infant safety. J Clin Psychopharmacol 36:244-252.
  • Uguz FJ. 2019. Antipsychotic use during pregnancy and the risk of gestational diabetes mellitus: A systematic review. Clin Psychopharmacol 39(2):162-167.