Antihistamines and birth defects: a systematic review of the literature

Bibliography

• Thorpe PG, Gilboa SM, Hernandez-Diaz S, et al. Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk. Pharmacoepidemiol Drug Saf 2013;22:1013-18
   PubMed Web of Science ®Google Scholar
• Werler MM, Mitchell AA, Hernandez-Diaz S, Honein MA. Use of over-the-counter medications during pregnancy. Am J Obstetr Gynecol 2005;193:771-7
   PubMed Web of Science ®Google Scholar
• Gilboa SM, Strickland MJ, Olshan AF, et al. Use of antihistamine medications during early pregnancy and isolated major malformations. Birth Defects Res A Clin Molec Teratol 2009;85:137-50
   PubMed Web of Science ®Google Scholar
• Brent R. Bendectin and birth defects: hopefully, the final chapter. Birth Defects Res A Clin Molec Teratol 2003;67:79-87
   PubMed Web of Science ®Google Scholar
• McKeigue PM, Lamm SH, Linn S, Kutcher JS. Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. Teratology 1994;50:27-37
   PubMedGoogle Scholar
• Einarson TR, Leeder JS, Koren G. A method for meta-analysis of epidemiological studies. Drug Intell Clin Pharmacy 1988;22:813-24
   PubMedGoogle Scholar
• MacMahon B. More on Bendectin. JAMA 1981;246:371-2
   PubMed Web of Science ®Google Scholar
• Beardsley T. Bendectin/debendox. Drug not guilty, says court. Nature 1985;314:209
   PubMed Web of Science ®Google Scholar
• Brent RL. Bendectin: review of the medical literature of a comprehensively studied human nonteratogen and the most prevalent tortogen-litigen. Reprod Toxicol 1995;9:337-49
   PubMed Web of Science ®Google Scholar
• Danks DM. Blame, compensation and birth defects. Med J Austr 1985;143:135-6
   PubMed Web of Science ®Google Scholar
• Davis JM. Good-bye, Bendectin, old friend. Postgrad Med 1984;75:20-4
   PubMed Web of Science ®Google Scholar
• Källén B. Use of antihistamine drugs in early pregnancy and delivery outcome. J Mat Fet Neonatal Med 2002;11:146-52
   PubMedGoogle Scholar
• Asker C, Norstedt Wikner B, Kallen B. Use of antiemetic drugs during pregnancy in Sweden. Eur J Clin Pharmacol 2005;61:899-906
   PubMed Web of Science ®Google Scholar
• Kullander S, Källén B. A prospective study of drugs and pregnancy. II. Anti-emetic drugs. Acta Obstetr Gynecol Scand 1976;55:105-11
   PubMed Web of Science ®Google Scholar
• McBride WG. An aetiological study of drug ingestion by women who gave birth to babies with cleft palate. Austr N Zeal J Obstet Gynecol 1969;9:103-4
   PubMed Web of Science ®Google Scholar
• Milkovich L, van den Berg BJ. An evaluation of the teratogenicity of certain antinauseant drugs. Am J Obstetr Gynecol 1976;125:244-8
   PubMed Web of Science ®Google Scholar
• Shapiro S, Kaufman DW, Rosenberg L, et al. Meclizine in pregnancy in relation to congenital malformations. BMJ 1978;1:483
   PubMed Web of Science ®Google Scholar
• Yerushalmy J, Milkovich L. Evaluation of the teratogenic effect of meclizine in man. Am J Obstetr Gynecol 1965;93:553-62
   PubMed Web of Science ®Google Scholar
• Källén B, Mottet I. Delivery outcome after the use of meclozine in early pregnancy. Eur J Epidemiol 2003;18:665-9
   PubMed Web of Science ®Google Scholar
• Ashkenazi-Hoffnung L, Merlob P, Stahl B, Klinger G. Evaluation of the efficacy and safety of bi-daily combination therapy with pyridoxine and doxylamine for nausea and vomiting of pregnancy. Israel Med Assoc J 2013;15:23-6
   PubMed Web of Science ®Google Scholar
• Boskovic R, Rudic N, Danieliewska-Nikiel B, et al. Is lack of morning sickness teratogenic? A prospective controlled study. Birth Defects Res A Clin Molec Teratol 2004;70:528-30
   PubMed Web of Science ®Google Scholar
• Einarson A, Bailey B, Jung G, et al. Prospective controlled study of hydroxyzine and cetirizine in pregnancy. Ann Allergy Asthma Immunol 1997;78:183-6
   PubMed Web of Science ®Google Scholar
• Erez S, Schifrin BS, Dirim O. Double-blind evaluation of hydroxyzine as an antiemetic in pregnancy. J Reprod Med 1971;7:35-27
   PubMed Web of Science ®Google Scholar
• Michaelis J, Michaelis H, Gluck E, Koller S. Prospective study of suspected associations between certain drugs administered during early pregnancy and congenital malformations. Teratology 1983;27:57-64
   PubMedGoogle Scholar
• Aselton P, Jick H, Milunsky A, et al. First-trimester drug use and congenital disorders. Obstetr Gynecol 1985;65:451-5
   PubMed Web of Science ®Google Scholar
• Jick H, Holmes LB, Hunter JR, et al. First-trimester drug use and congenital disorders. JAMA 1981;246:343-6
   PubMed Web of Science ®Google Scholar
• Schatz M, Zeiger RS, Harden K, et al. The safety of asthma and allergy medications during pregnancy. J Allergy Clin Immunol 1997;100:301-6
   PubMed Web of Science ®Google Scholar
• Bsat FA, Hoffman DE, Seubert DE. Comparison of three outpatient regimens in the management of nausea and vomiting in pregnancy. J Perinatol 2003;23:531-5
   PubMedGoogle Scholar
• Diav-Citrin O, Shechtman S, Aharonovich A, et al. Pregnancy outcome after gestational exposure to loratadine or antihistamines: a prospective controlled cohort study. J Allergy Clin Immunol 2003;111:1239-43
   PubMed Web of Science ®Google Scholar
• Källén B, Olausson PO. Monitoring of maternal drug use and infant congenital malformations. Does loratadine cause hypospadias? Int J Risk Safety Med 2001;14:115-19
   Google Scholar
• Källén B, Olausson PO. No increased risk of infant hypospadias after maternal use of loratadine in early pregnancy. Int J Med Sci 2006;3:106-7
   PubMedGoogle Scholar
• Loebstein R, Lalkin A, Addis A, et al. Pregnancy outcome after gestational exposure to terfenadine: a multicenter, prospective controlled study. J Allergy Clin Immunol 1999;104:953-6
   PubMed Web of Science ®Google Scholar
• Moretti ME, Caprara D, Coutinho CJ, et al. Fetal safety of loratadine use in the first trimester of pregnancy: a multicenter study. J Allergy Clin Immunol 2003;111:479-83
   PubMed Web of Science ®Google Scholar
• Pastuszak A, Schick B, D’Alimonte D, et al. The safety of astemizole in pregnancy. J Allergy Clin Immunol 1996;98:748-50
   PubMed Web of Science ®Google Scholar
• Weber-Schoendorfer C, Schaefer C. The safety of cetirizine during pregnancy. A prospective observational cohort study. Reprod Toxicol 2008;26:19-23
   PubMed Web of Science ®Google Scholar
• Källén B, Robert-Gnansia E. Maternal drug use, fertility problems, and infant craniostenosis. Cleft Palate Craniofac J 2005;42:589-93
   PubMed Web of Science ®Google Scholar
• Werler MM, Mitchell AA, Shapiro S. First trimester maternal medication use in relation to gastroschisis. Teratology 1992;45:361-7
   PubMedGoogle Scholar
• Werler MM, Sheehan JE, Mitchell AA. Maternal medication use and risks of gastroschisis and small intestinal atresia. Am J Epidemiol 2002;155:26-31
   PubMed Web of Science ®Google Scholar
• Boneva RS, Moore CA, Botto L, et al. Nausea during pregnancy and congenital heart defects: a population-based case-control study. Am J Epidemiol 1999;149:717-25
   PubMed Web of Science ®Google Scholar
• Aselton P, Jick H, Chentow SJ, et al. Pyloric stenosis and maternal Bendectin exposure. Am J Epidemiol 1984;120:251-6
   PubMed Web of Science ®Google Scholar
• Eskenazi B, Bracken MB. Bendectin (Debendox) as a risk factor for pyloric stenosis. Am J Obstetr Gynecol 1982;144:919-24
   PubMed Web of Science ®Google Scholar
• Aselton P, Jick H. Re: pyloric stenosis and maternal antihistamine exposure at group health cooperative. Am J Epidemiol 1985;122:197
   PubMed Web of Science ®Google Scholar
• Eskenazi B, Bracken MB. Pyloric stenosis and antihistamines. Am J Epidemiol 1985;122:196-7
   PubMed Web of Science ®Google Scholar
• Mellin GW, Katzenstein M. Meclozine and foetal abnormalities. Lancet 1963;1:222-3
   PubMed Web of Science ®Google Scholar
• Idanpaan-Heikkila J, Saxen L. Possible teratogenicity of imipramine-chloropyramine. Lancet 1973;2:282-4
   PubMed Web of Science ®Google Scholar
• Saxen I. Letter: cleft palate and maternal diphenhydramine intake. Lancet 1974;1:407-8
   PubMed Web of Science ®Google Scholar
• Golding J, Vivian S, Baldwin JA. Maternal anti-nauseants and clefts of lip and palate. Human Toxicol 1983;2:63-73
   PubMedGoogle Scholar
• Nelson MM, Forfar JO. Associations between drugs administered during pregnancy and congenital abnormalities of the fetus. BMJ 1971;1:523-7
   PubMed Web of Science ®Google Scholar
• Czeizel AE, Vargha P. A case-control study of congenital abnormality and dimenhydrinate usage during pregnancy. Arch Gynecol Obstetr 2005;271:113-18
   PubMedGoogle Scholar
• Bartfai Z, Kocsis J, Puho EH, Czeizel AE. A population-based case-control teratologic study of promethazine use during pregnancy. Reprod Toxicol 2008;25:276-85
   PubMed Web of Science ®Google Scholar
• Czeizel AE, Sarkozi A, Wyszynski DF. Protective effect of hyperemesis gravidarum for nonsyndromic oral clefts. Obstetr Gynecol 2003;101:737-44
   PubMed Web of Science ®Google Scholar
• Verberg MF, Gillott DJ, Al-Fardan N, Grudzinskas JG. Hyperemesis gravidarum, a literature review. Hum Reprod Update 2005;11:527-39
   PubMed Web of Science ®Google Scholar
• Anderka M, Mitchell AA, Louik C, et al. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Molec Teratol 2012;94:22-30
   PubMed Web of Science ®Google Scholar
• Li Q, Mitchell AA, Werler MM, et al. Assessment of antihistamine use in early pregnancy and birth defects. J Allergy Clin Immunol: In Practice 2013;1:666-74
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Evaluation of an association between loratadine and hypospadias–United States, 1997-2001. MMWR Morbidity and Mortality Weekly Report 2004;53:219-21
   PubMedGoogle Scholar
• Pedersen L, Norgaard M, Rothman KJ, Sorensen HT. Loratadine during pregnancy and hypospadias. Epidemiology 2008;19:359-60
   PubMed Web of Science ®Google Scholar
• Pedersen L, Norgaard M, Skriver MV, et al. Prenatal exposure to loratadine in children with hypospadias: a nested case-control study within the Danish National Birth Cohort. Am J Therapeutics 2006;13:320-4
   PubMedGoogle Scholar
• Pedersen L, Skriver MV, Norgaard M, Sorensen HT. Maternal use of loratadine during pregnancy and risk of hypospadias in offspring. Int J Med Sci 2006;3:21-5
   PubMedGoogle Scholar
• Colin Jones DG, Langman MJ, Lawson DH, Vessey MP. Post-marketing surveillance of the safety of cimetidine: twelve-month morbidity report. Quarterly J Med 1985;54:253-68
   PubMedGoogle Scholar
• Garbis H, Elefant E, Diav-Citrin O, et al. Pregnancy outcome after exposure to ranitidine and other H2-blockers. A collaborative study of the European Network of Teratology Information Services. Reprod Toxicol 2005;19:453-8
   PubMed Web of Science ®Google Scholar
• Källén B. Delivery outcome after the use of acid-suppressing drugs in early pregnancy with special reference to omeprazole. Br J Obstetr Gynecol 1998;105:877-81
   PubMedGoogle Scholar
• Magee LA, Inocencion G, Kamboj L, et al. Safety of first trimester exposure to histamine H2 blockers. A prospective cohort study. Dig Dis Sci 1996;41:1145-9
   PubMed Web of Science ®Google Scholar
• Matok I, Gorodischer R, Koren G, et al. The safety of H(2)-blockers use during pregnancy. J Clin Pharmacol 2010;50:81-7
   PubMed Web of Science ®Google Scholar
• Ruigomez A, Garcia Rodriguez LA, Cattaruzzi C, et al. Use of cimetidine, omeprazole, and ranitidine in pregnant women and pregnancy outcomes. Am J Epidemiol 1999;150:476-81
   PubMed Web of Science ®Google Scholar
• Lalkin A, Loebstein R, Addis A, et al. The safety of omeprazole during pregnancy: a multicenter prospective controlled study. Am J Obstetr Gynecol 1998;179:727-30
   PubMed Web of Science ®Google Scholar
• Ács N, Bánhidy F, Puho EH, Czeizel AE. A possible association between maternal dyspepsia and congenital rectal/anal atresia/stenosis in their children: a population-based case-control study. Acta Obstetr Gynecol Scand 2009;88:1017-23
   PubMed Web of Science ®Google Scholar
• Bánhidy F, Dakhlaoui A, Puho EH, Czeizel AE. Peptic ulcer disease with related drug treatment in pregnant women and congenital abnormalities in their offspring. Congen Anomal 2011;51:26-33
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Update on overall prevalence of major birth defects–Atlanta, Georgia, 1978-2005. MMWR Morbidity and Mortality Weekly Report 2008;57:1-5
   PubMedGoogle Scholar
• Shapiro S, Heinonen OP, Siskind V, et al. Antenatal exposure to doxylamine succinate and dicyclomine hydrochloride (Benedectin) in relation to congenital malformations, perinatal mortality rate, birth weight, and intelligence quotient score. Am J Obstetr Gynecol 1977;128:480-5
   PubMed Web of Science ®Google Scholar
• Hardy JB. The Collaborative Perinatal Project: lessons and legacy. Ann Epidemiol 2003;13:303-11
   PubMed Web of Science ®Google Scholar
• Klebanoff MA. The Collaborative Perinatal Project: a 50-year retrospective. Paediatr Perinatal Epidemiol 2009;23:2-8
   PubMed Web of Science ®Google Scholar
• Honein MA, Moore CA. The safety or risk of antihistamine use in pregnancy: reassuring data are helpful but not sufficient. J Allergy Clin Immunol: In Practice 2013;1:675-6
   Google Scholar
• Olesen C, Sondergaard C, Thrane N, et al. Do pregnant women report use of dispensed medications? Epidemiology 2001;12:497-501
   PubMed Web of Science ®Google Scholar
• Werler MM, Pober BR, Nelson K, Holmes LB. Reporting accuracy among mothers of malformed and nonmalformed infants. Am J Epidemiol 1989;129:415-21
   PubMed Web of Science ®Google Scholar
• Cogswell ME, Bitsko RH, Anderka M, et al. National Birth Defects Prevention Study. Control selection and participation in an ongoing, population-based, case-control study of birth defects: the National Birth Defects Prevention Study. Am J Epidemiol 2009;170:975-85
   PubMed Web of Science ®Google Scholar
• Sadler TW. Langman’s Medical Embryology. 8th Edition. Lippincott Williams & Wilkins; Philadelphia: 2004
   Google Scholar
• Yau WP, Lin KJ, Werler MM, et al. Drug certainty-response in interview-based studies. Pharmacoepidemiol Drug Saf 2011;20:1210-16
   PubMed Web of Science ®Google Scholar
• Psaty BM, Koepsell TD, Lin D, et al. Assessment and control for confounding by indication in observational studies. J Am Geriatrics Soc 1999;47:749-54
   PubMed Web of Science ®Google Scholar
• Mitchell AA, Gilboa SM, Werler MM, National Birth Defects Prevention Study. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol 2011;205:51.e1-8
   PubMed Web of Science ®Google Scholar
• Botto LD, Lin AE, Riehle-Colarusso T, et al. Seeking causes: classifying and evaluating congenital heart defects in etiologic studies. Birth Defects Res A Clin Molec Teratol 2007;79:714-27
   PubMed Web of Science ®Google Scholar
• Rasmussen SA, Olney RS, Holmes LB, et al. Guidelines for case classification for the National Birth Defects Prevention Study. Birth Defects Res A Clin Molec Teratol 2003;67:193-201
   PubMed Web of Science ®Google Scholar
• Riehle-Colarusso T, Strickland MJ, Reller MD, et al. Improving the quality of surveillance data on congenital heart defects in the metropolitan Atlanta congenital defects program. Birth Defects Res A Clin Molec Teratol 2007;79:743-53
   PubMed Web of Science ®Google Scholar