Maternal use of fluconazole and risk of congenital malformations: A Danish population-based cohort study

Journal of Antimicrobial Chemotherapy

Volumn 62, Issue 1, 2008, Pages 172-176

  Nørgaard, Mette ^a   Pedersen, Lars ^a   Gislum, Mette ^a   Erichsen, Rune ^a   Søgaard, Kirstine Kobberøe ^a   Schønheyder, Henrik Carl ^b   Sørensen, Henrik Toft ^a  

^a AARHUS UNIVERSITY HOSPITAL   (Denmark)

^b AALBORG UNIVERSITY HOSPITAL   (Denmark)

Author keywords

Antifungals; Drug safety; Epidemiology; Pregnancy

Indexed keywords

ANTICONVULSIVE AGENT; ANTIDIABETIC AGENT; FLUCONAZOLE;

ARTICLE; BONE MALFORMATION; CARDIOVASCULAR MALFORMATION; CLUBFOOT; COHORT ANALYSIS; CONFIDENCE INTERVAL; CONGENITAL MALFORMATION; CONTROLLED STUDY; COVARIANCE; CRANIOFACIAL MALFORMATION; DENMARK; DRUG USE; EYE MALFORMATION; FEMALE; FIRST TRIMESTER PREGNANCY; GESTATIONAL AGE; HIRSCHSPRUNG DISEASE; HUMAN; HYPOSPADIAS; INFANT; LIVE BIRTH; LOGISTIC REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; MATERNAL AGE; MATERNAL DISEASE; MATERNAL SMOKING; MULTICYSTIC DYSPLASTIC KIDNEY; NEURAL TUBE DEFECT; PARITY; PREGNANCY; PRENATAL DRUG EXPOSURE; PRESCRIPTION; PREVALENCE; PYLORUS STENOSIS; REGISTER; RISK FACTOR; SHORT COURSE THERAPY; STILLBIRTH;

ABNORMALITIES, DRUG-INDUCED; ANTIFUNGAL AGENTS; CANDIDIASIS; COHORT STUDIES; DENMARK; FEMALE; FLUCONAZOLE; HUMANS; INFANT, NEWBORN; PREGNANCY; PREGNANCY COMPLICATIONS; PREGNANCY COMPLICATIONS, INFECTIOUS;

EID: 45749087733     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dkn157     Document Type: Article

References (28)

1. Cha R, Sobel JD. Fluconazole for the treatment of candidiasis: 15 years experience. Expert Rev Anti Infect Ther 2004; 2: 357-66.
2. Grigoriou O, Baka S, Makrakis E et al. Prevalence of clinical vaginal candidiasis in a university hospital and possible risk factors. Eur J Obstet Gynecol Reprod Biol 2006; 126: 121-5.
3. Moudgal VV, Sobel JD. Antifungal drugs in pregnancy: A review. Expert Opin Drug Saf 2003; 2: 475-83.
4. Lee BE, Feinberg M, Abraham JJ et al. Congenital malformations in an infant born to a woman treated with fluconazole. Pediatr Infect Dis J 1992; 11: 1062-4.
5. Pursley TJ, Blomquist IK, Abraham J et al. Fluconazole-induced congenital anomalies in three infants. Clin Infect Dis 1996; 22 336-40.
6. Aleck KA, Bartley DL. Multiple malformation syndrome following fluconazole use in pregnancy: Report of an additional patient. Am J Med Genet 1997; 72: 253-6.
7. Lopez-Rangel E, Van Allen MI. Prenatal exposure to fluconazole: An identifiable dysmorphic phenotype. Birth Defects Res A Clin Mol Teratol 2005; 73: 919-23.
8. Sanchez JM, Moya G. Fluconazole teratogenicity. Prenat Diagn 1998; 18: 862-3.
9. Inman W, Pearce G, Wilton L. Safety of fluconazole in the treatment of vaginal candidiasis. A prescription-event monitoring study, with special reference to the outcome of pregnancy. Eur J Clin Pharmacol 1994; 46: 115-8.
10. Campomori A, Bonati M. Fluconazole treatment for vulvovaginal candidiasis during pregnancy. Ann Pharmacother 1997; 31: 118-9.
11. Jick SS. Pregnancy outcomes after maternal exposure to fluconazole. Pharmacotherapy 1999; 19: 221-2.
12. Sørensen HT, Nielsen GIL, Olesen C et al. Risk of malformations and other outcomes in children exposed to fluconazole in utero. Br J Clin Pharmacol 1999; 48: 234-8.
13. Mastroiacovo P, Mazzone T, Botto LD et al. Prospective assessment of pregnancy outcomes after first-trimester exposure to fluconazole. Am J Obstet Gynecol 1996; 175: 1645-50.
14. Mitchell A. Special considerations in studies of drug-induced birth defects. In: Strom BL, ed. Pharmacoepidemiology, 4th edn. West Sussex: John Wiley and Sons Ltd, 2005; 501-14.
15. Knudsen LB, Olsen J. The Danish Medical Birth Registry. Dan Med Bull 1998; 45: 320-3.
16. Marson AG, Al-Kharusi AM, Alwaidh M et al. The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: An unblinded randomised controlled trial. Lancet 2007; 369: 1016-26.
17. Fonager K, Larsen H, Pedersen L et al. Birth outcomes in women exposed to anticonvulsant drugs. Acta Neurol Scand 2000; 101 289-94.
18. Nielsen GL, Nørgard B, Puho E et al. Risk of specific congenital abnormalities in offspring of women with diabetes. Diabet Med 2005; 22: 693-6.
19. Larsen H, Nielsen GL, Bendsen J et al. Predictive value and completeness of the registration of congenital abnormalities in three Danish population-based registries. Scand J Public Health 2003; 31: 12-6.
20. Roizen NJ, Patterson D. Down's syndrome. Lancet 2003; 361: 1281-9.
21. Fleiss JL. The statistical basis of meta-analysis. Stat Methods Med Res 1993; 2: 121-45.
22. Menegola E, Broccia ML, Di Renzo F et al. Antifungal triazoles induce malformations in vitro. Reprod Toxicol 2001; 15: 421-7.
23. Menegola E, Broccia ML, Di Renzo F et al. Study on the common teratogenic pathway elicited by the fungicides triazole-derivatives. Toxicol In Vitro 2005; 19: 737-48.
24. Van CH, Lampo A, Vandenberghe J et al. Safety aspects of oral antifungal agents. Br J Clin Pract Suppl 1990; 71: 47-9.
25. Sadler TW. Langman's Medical Embryology. Baltimore: Lippincott Williams & Wilkins, 1995.
26. Jepsen B, Jepsen P, Johnsen SP et al. Validity of recorded diagnoses of congenital cardiac malformations in a Danish population-based hospital-discharge registry. Int J Risk Saf Med 2006; 18: 77-81.
27. Lægemiddelkataloget 2005-2006. Copenhagen: Dansk Lægemiddel Information, 2005.
28. Johnson KA, Weber PA, Jones KL et al. Selection bias in Teratology Information Service pregnancy outcome studies. Teratology 2001; 64: 79-82.