Abstract
Attention has recently focused on the possible teratogenic effects of the combination antiemetic doxylamine succinate, dicyclomine hydrochloride and pyridoxine hydrochloride (Debendox/Bendectin) prescribed to pregnant women. The Inter-Regional Epidemiological Study of Childhood Cancer (IRESCC), a case-control investigation has analysed data derived from interview reports and medical records of 555 mothers of children (under 15 years) with cancer and 1110 mothers of matched control children. Separate analyses of interview reports and medical records both suggested that antiemetic ingestion during the index pregnancy does not increase the risk of developing childhood malignant disease in the exposed foetus. No dose-response relationship was evident. The lack of any significant relative risks held good for diagnostic sub-groups and when the trimester of ingestion was considered. Our results suggest that antimetics of this type are unlikely to be transplacental carcinogens.
Full text
PDF






Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Birch J. M., Mann J. R., Cartwright R. A., Draper G. J., Waterhouse J. A., Hartley A. L., Johnston H. E., McKinney P. A., Stiller C. A., Hopton P. A. The Inter-Regional Epidemiological Study of Childhood Cancer (IRESCO). Study design, control selection and data collection. Br J Cancer. 1985 Dec;52(6):915–922. doi: 10.1038/bjc.1985.277. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Cordero J. F., Oakley G. P., Jr Drug exposure during pregnancy: some epidemiologic considerations. Clin Obstet Gynecol. 1983 Jun;26(2):418–428. doi: 10.1097/00003081-198306000-00023. [DOI] [PubMed] [Google Scholar]
- Correy J. F., Newman N. M. Debendox and limb reduction deformities. Med J Aust. 1981 Apr 18;1(8):417–418. doi: 10.5694/j.1326-5377.1981.tb135685.x. [DOI] [PubMed] [Google Scholar]
- DiPaolo J. A., Kotin P. Teratogenesis-oncogenesis: a study of possible relationships. Arch Pathol. 1966 Jan;81(1):3–23. [PubMed] [Google Scholar]
- DonnaiD, Harris R. Unusual fetal malformations after antiemetics in early pregnancy. Br Med J. 1978 Mar 18;1(6114):691–692. doi: 10.1136/bmj.1.6114.691. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Ehrenbard L. T., Chaganti R. S. Cancer in the fetal hydantoin syndrome. Lancet. 1981 Jul 11;2(8237):97–97. doi: 10.1016/s0140-6736(81)90452-9. [DOI] [PubMed] [Google Scholar]
- 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 Apr 18;1(8):410–414. [PubMed] [Google Scholar]
- Gill W. B., Schumacher G. F., Bibbo M. Pathological semen and anatomical abnormalities of the genital tract in human male subjects exposed to diethylstilbestrol in utero. J Urol. 1977 Apr;117(4):477–480. doi: 10.1016/s0022-5347(17)58502-x. [DOI] [PubMed] [Google Scholar]
- Hall J. B. Debendox in pregnancy. Lancet. 1981 Jul 18;2(8238):154–155. doi: 10.1016/s0140-6736(81)90339-1. [DOI] [PubMed] [Google Scholar]
- Harron D. W., Griffiths K., Shanks R. G. Debendox and congenital malformations in Northern Ireland. Br Med J. 1980 Nov 22;281(6252):1379–1381. doi: 10.1136/bmj.281.6252.1379. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Janerich D. T., Glebatis D., Flink E., Hoff M. B. Case-control studies on the effect of sex steroids on women and their offspring. J Chronic Dis. 1979;32(1-2):83–88. doi: 10.1016/0021-9681(79)90018-3. [DOI] [PubMed] [Google Scholar]
- Jick H., Holmes L. B., Hunter J. R., Madsen S., Stergachis A. First-trimester drug use and congenital disorders. JAMA. 1981 Jul 24;246(4):343–346. [PubMed] [Google Scholar]
- Kinney H., Faix R., Brazy J. The fetal alcohol syndrome and neuroblastoma. Pediatrics. 1980 Jul;66(1):130–132. [PubMed] [Google Scholar]
- Larson H. E., Parkman P. D., Davis W. J., Hopps H. E., Meyer H. M., Jr Inadvertent rubella virus vaccination during pregnancy. N Engl J Med. 1971 Apr 15;284(15):870–873. doi: 10.1056/NEJM197104222841602. [DOI] [PubMed] [Google Scholar]
- Miller R. W. Relationship between human teratogens and carcinogens. J Natl Cancer Inst. 1977 Mar;58(3):471–474. doi: 10.1093/jnci/58.3.471. [DOI] [PubMed] [Google Scholar]
- 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 Apr;109(4):433–439. doi: 10.1093/oxfordjournals.aje.a112701. [DOI] [PubMed] [Google Scholar]
- Salonen T. Prenatal and perinatal factors in childhood cancer. Ann Clin Res. 1976 Feb;8(1):27–42. [PubMed] [Google Scholar]
- Shapiro S., Heinonen O. P., Siskind V., Kaufman D. W., Monson R. R., Slone D. 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 Obstet Gynecol. 1977 Jul 1;128(5):480–485. doi: 10.1016/0002-9378(77)90028-x. [DOI] [PubMed] [Google Scholar]
- Smithells R. W., Sheppard S. Teratogenicity testing in humans: a method demonstrating safety of bendectin. Teratology. 1978 Feb;17(1):31–35. doi: 10.1002/tera.1420170109. [DOI] [PubMed] [Google Scholar]
- Winship K. A., Cahal D. A., Weber J. C., Griffin J. P. Maternal drug histories and central nervous system anomalies. Arch Dis Child. 1984 Nov;59(11):1052–1060. doi: 10.1136/adc.59.11.1052. [DOI] [PMC free article] [PubMed] [Google Scholar]
