Re-analysis of safety data supporting doxylamine use for nausea and vomiting of pregnancy

American Journal of Perinatology

Volumn 31, Issue 8, 2014, Pages 701-710

  Chin, Jessica W S ^a   Gregor, Sarah ^a   Persaud, Navindra ^a,b,c  

^a ST MICHAEL'S HOSPITAL   (Canada)

^b ST MICHAEL'S HOSPITAL   (Canada)

^c UNIVERSITY OF TORONTO   (Canada)

Author keywords

congenital malformations; doxylamine; drug safety; nausea and vomiting of pregnancy

Indexed keywords

ANTIHISTAMINIC AGENT; DOXYLAMINE; ANTIEMETIC AGENT;

ARTICLE; CLINICAL TRIAL; CONGENITAL MALFORMATION; DRUG SAFETY; HUMAN; META ANALYSIS; NAUSEA AND VOMITING; PREGNANCY; PRENATAL EXPOSURE; PRIORITY JOURNAL; SYSTEMATIC REVIEW; CONGENITAL ABNORMALITIES; FEMALE; MORNING SICKNESS; RISK;

ANTIEMETICS; CONGENITAL ABNORMALITIES; DOXYLAMINE; FEMALE; HUMANS; MORNING SICKNESS; ODDS RATIO; PREGNANCY; RISK;

EID: 84904857825     PISSN: 07351631     EISSN: 10988785     Source Type: Journal    
DOI: 10.1055/s-0033-1358772     Document Type: Article

References (41)

1. Gadsby R., Barnie-Adshead A. M., Jagger C. A prospective study of nausea and vomiting during pregnancy. Br J Gen Pract: 1993; 43 371 245 248 (Pubitemid 23203917)
2. Lacroix R., Eason E., Melzack R. Nausea and vomiting during pregnancy: a prospective study of its frequency, intensity, and patterns of change. Am J Obstet Gynecol: 2000; 182 4 931 937 (Pubitemid 30228470)
3. Briggs G., Freeman R. K., Yaffe S. J. Doxylamine. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risks. 9th ed. Philadelphia Lippincott Williams & Wilkins: 2011; 4527
4. Public Health Agency of Canada Statement on Pregnancy and Travel; 2010. Available at: http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/10vol36/acs-2/index- eng.php. Accessed May 17, 2012
5. Arsenault M. Y., Lane C. A., MacKinnon C. J., et al. The management of nausea and vomiting of pregnancy. J Obstet Gynaecol Can: 2002; 24 10 817 831, quiz 832-833
6. Einarson A., Maltepe C., Boskovic R., Koren G. Treatment of nausea and vomiting in pregnancy: an updated algorithm. Can Fam Physician: 2007; 53 12 2109 2111 (Pubitemid 351198284)
7. Seto A., Einarson T., Koren G. Pregnancy outcome following first trimester exposure to antihistamines: meta-analysis. Am J Perinatol: 1997; 14 3 119 124 (Pubitemid 27143335)
8. Kar S., Krishnan A., Preetha K., Mohankar A. A review of antihistamines used during pregnancy. J Pharmacol Pharmacother: 2012; 3 2 105 108
9. So M., Bozzo P., Inoue M., Einarson A. Safety of antihistamines during pregnancy and lactation. Can Fam Physician: 2010; 56 5 427 429
10. Magee L. A., Mazzotta P., Koren G. Evidence-based view of safety and effectiveness of pharmacologic therapy for nausea and vomiting of pregnancy (NVP). Am J Obstet Gynecol: 2002; 186 (5, Suppl Understanding): S256 S261 (Pubitemid 34533885)
11. Mazzotta P., Magee L. A. A risk-benefit assessment of pharmacological and non-pharmacological treatments for nausea and vomiting of pregnancy. Drugs: 2000; 59 781 800 (Pubitemid 30232320)
12. Ayd F. J. Jr. Haloperidol: fifteen years of clinical experience. Dis Nerv Syst: 1972; 33 7 459 469
13. Aselton P. J., Jick H. Additional follow-up of congenital limb disorders in relation to Bendectin use. JAMA: 1983; 250 1 33 34 (Pubitemid 13066541)
14. Gibson G. T., Colley D. P., McMichael A. J., Hartshorne J. M. Congenital anomalies in relation to the use of doxylamine/dicyclomine and other antenatal factors: an ongoing prospective study. Med J Aust: 1981; 1 8 410 414 (Pubitemid 11041472)
15. Bunde C. A., Bowles D. M. A technique for controlled survey of case records. Curr Ther Res Clin Exp: 1963; 5 245 248
16. Kullander S., Källén B. A prospective study of drugs and pregnancy. II. Anti-emetic drugs. Acta Obstet Gynecol Scand: 1976; 55 2 105 111
17. Jick H., Holmes L. B., Hunter J. R., Madsen S., Stergachis A. First-trimester drug use and congenital disorders. JAMA: 1981; 246 4 343 346 (Pubitemid 12251384)
18. Golding J., Vivian S., Baldwin J. A. Maternal anti-nauseants and clefts of lip and palate. Hum Toxicol: 1983; 2 1 63 73 (Pubitemid 13046691)
19. Greenberg G., Inman W. HW, Weatherall J. AC, Adelstein A. M., Haskey J. C. Maternal drug histories and congenital abnormalities. BMJ: 1977; 2 6091 853 856 (Pubitemid 8187368)
20. Newman N. M., Correy J. F., Dudgeon G. I. A survey of congenital abnormalities and drugs in a private practice. Aust N Z J Gynaecol: 1977; 17 156 159 (Pubitemid 8235081)
21. General Practitioner Research Group General Practitioner Clinical Trials: drugs in pregnancy survey. Practitioner: 1963; 191 775 780
22. Smithells R. W., Sheppard S. Teratogenicity testing in humans: a method demonstrating safety of bendectin. Teratology: 1978; 17 1 31 35 (Pubitemid 8280583)
23. Zierler S., Rothman K. J. Congenital heart disease in relation to maternal use of Bendectin and other drugs in early pregnancy. N Engl J Med: 1985; 313 6 347 352 (Pubitemid 15046366)
24. Heinonen O. P., Slone D., Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton MA PSG Publishing: 1977
25. Mellin G., Katzenstein M. Meclozine and fetal abnormalities. Lancet: 1963; 26 222 223
26. Milkovich L., van den Berg B. J. An evaluation of the teratogenicity of certain antinauseant drugs. Am J Obstet Gynecol: 1976; 125 2 244 248
27. Nelson M. M., Forfar J. O. Associations between drugs administered during pregnancy and congenital abnormalities of the fetus. BMJ: 1971; 1 5748 523 527
28. Rothman K. J., Fyler D. C., Goldblatt A., Kreidberg M. B. Exogenous hormones and other drug exposures of children with congenital heart disease. Am J Epidemiol: 1979; 109 4 433 439 (Pubitemid 10201094)
29. Morelock S., Hingson R., Kayne H., et al. Bendectin and fetal development. A study of Boston City Hospital. Am J Obstet Gynecol: 1982; 142 2 209 213 (Pubitemid 12222102)
30. McKeigue P. M., Lamm S. H., Linn S., Kutcher J. S. Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. Teratology: 1994; 50 1 27 37 (Pubitemid 24246849)
31. Michaelis J., Gluck E., Michaelis H., et al. Does Lenotan have teratogenic effects? Dtsch Arzt: 1980; 23 1527 1529 (Pubitemid 10060668)
32. Shiono P. H., Klebanoff M. A. Bendectin and human congenital malformations. Teratology: 1989; 40 2 151 155 (Pubitemid 19215702)
33. Aselton P., Jick H., Milunsky A., Hunter J. R., Stergachis A. First-trimester drug use and congenital disorders. Obstet Gynecol: 1985; 65 4 451 455 (Pubitemid 15099137)
34. Erickson J. D. Risk factors for birth defects: data from the Atlanta Birth Defects Case-Control Study. Teratology: 1991; 43 1 41 51
35. Fejzo M. S., Ingles S. A., Wilson M., et al. High prevalence of severe nausea and vomiting of pregnancy and hyperemesis gravidarum among relatives of affected individuals. Eur J Obstet Gynecol Reprod Biol: 2008; 141 1 13 17
36. Matthews A., Dowswell T., Haas D. M., Doyle M., O'Mathúna D. P. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev: 2010; (9, Issue 9) CD007575
37. Seto A., Einarson T., Koren G. Evaluation of brompheniramine safety in pregnancy. Reprod Toxicol: 1993; 7 4 393 395
38. Nora J. J., Nora A. H., Sommerville R. J., Hill R. M., McNamara D. G. Maternal exposure to potential teratogens. JAMA: 1967; 202 12 1065 1069
39. Fleming D. M., Knox J. DE, Crombie D. L. Debendox in early pregnancy and fetal malformation. Br Med J (Clin Res Ed): 1981; 283 6284 99 101 (Pubitemid 11064594)
40. Michaelis J., Michaelis H., Glück E., Koller S. Prospective study of suspected associations between certain drugs administered during early pregnancy and congenital malformations. Teratology: 1983; 27 1 57 64 (Pubitemid 13152107)
41. Eskenazi B., Bracken M. B. Bendectin (Debendox) as a risk factor for pyloric stenosis. Am J Obstet Gynecol: 1982; 144 8 919 924 (Pubitemid 13216772)