Risks of congenital malformations and perinatal events among infants exposed to calcium channel and beta-blockers during pregnancy

Pharmacoepidemiology and Drug Safety

Volumn 20, Issue 2, 2011, Pages 138-145

  Davis, Robert L ^a   Eastman, David ^b   McPhillips, Heather ^c   Raebel, Marsha A ^d   Andrade, Susan E ^e   Smith, David ^f   Yood, Marianne Ulcickas ^g   Dublin, Sascha ^h   Platt, Richard ⁱ  

^a Center for Health Research   (United States)

^b CENTER FOR HEALTH STUDIES   (United States)

^c UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^d Kaiser Permanente Colorado   (United States)

^e UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^f KAISER PERMANENTE   (United States)

^g HENRY FORD HEALTH SYSTEM   (United States)

^h GROUP HEALTH RESEARCH INSTITUTE   (United States)

ⁱ HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Anomalies; Beta blockers; Calcium channel blockers; Drug safety; Malformation; Perinatal; Pregnancy; Prescription drug

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; PRESCRIPTION DRUG;

ADOLESCENT; ARTICLE; CONGENITAL MALFORMATION; DELIVERY; FEEDING DISORDER; FEMALE; FOLLOW UP; HEALTH MAINTENANCE ORGANIZATION; HOSPITAL PATIENT; HUMAN; HYPOGLYCEMIA; INFANT; MAJOR CLINICAL STUDY; MEDICAL RECORD REVIEW; NEWBORN; NEWBORN DISEASE; OUTPATIENT; POPULATION RESEARCH; PREGNANCY; PRIORITY JOURNAL; RETROSPECTIVE STUDY; RISK ASSESSMENT; RISK FACTOR; SEIZURE; THIRD TRIMESTER PREGNANCY;

ABNORMALITIES, DRUG-INDUCED; ADOLESCENT; ADRENERGIC BETA-ANTAGONISTS; ADULT; CALCIUM CHANNEL BLOCKERS; DRUG PRESCRIPTIONS; FEMALE; HEALTH MAINTENANCE ORGANIZATIONS; HUMANS; HYPOGLYCEMIA; INFANT, NEWBORN; INSURANCE, PHARMACEUTICAL SERVICES; PREGNANCY; PREGNANCY TRIMESTER, THIRD; PRENATAL EXPOSURE DELAYED EFFECTS; RETROSPECTIVE STUDIES; RISK ASSESSMENT; RISK FACTORS; SEIZURES; TIME FACTORS; UNITED STATES; YOUNG ADULT;

EID: 78751699545     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2068     Document Type: Article

References (37)

1. Andrade SE, Gurwitz JH, Davis RL, et al. Prescription drug use in pregnancy. Am J Obstet Gynecol 2004; 191(2): 398-407.
2. Sibai BM. Treatment of hypertension in pregnant women. N Engl J Med 1996; 335(4): 257-265.
3. Lalkin A, Loebstein R, Addis A, Koren G. Therapeutic approach to hypertension during pregnancy. Can Fam Physician 1998; 44: 1245-1247.
4. Magee LA, Ornstein MP, von Dadelszen P. Fortnightly review: management of hypertension in pregnancy. Br Med J 1999; 318(7194): 1332-1336.
5. Rosenthal T, Oparil S. The effect of antihypertensive drugs on the fetus. J Hum Hypertens 2002; 16(5): 293-298.
6. Sibai BM. Chronic hypertension in pregnancy. Obstet Gynecol 2002; 100(2): 369-377.
7. Qasqas SA, McPherson C, Frishman WH, Elkayam U. Cardiovascular pharmacotherapeutic considerations during pregnancy and lactation. Cardiol Rev 2004; 12(5): 240-261.
8. Cooper WO, Hernandez-Diaz S, Arbogast PG, et al. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med 2006; 354(23): 2443-2451.
9. Friedman JM. ACE inhibitors and congenital anomalies. N Engl J Med 2006; 354(23): 2498-2500.
10. Quan A. Fetopathy associated with exposure to angiotensin converting enzyme inhibitors and angiotensin receptor antagonists. Early Hum Dev 2006; 82(1): 23-28.
11. Fukunishi K, Yokoi Y, Yoshida H, Nose T. Effects of nifedipine on rat fetuses. Med Consult New Remed 1980; 17: 2245-2256.
12. Cabov A, Palka E. Some effects of Cordipin (nifedipine) administered during pregnancy in rats. Teratology 1984; 29: 21.
13. Yoshida T, Kanamori S, Hasegawa Y. Hyperphalangeal bones induced in rat pups by maternal treatment with nifedipine. Toxicol Lett 1988; 40(2): 127-132.
14. Danielsson BR, Reiland S, Rundqvist E, Danielson M. Digital defects induced by vasodilating agents: relationship to reduction in uteroplacental blood flow. Teratology 1989; 40(4): 351-358.
15. Komai H, Redon D, Rusy BF. Effects of thiopental and halothane on spontaneous contractile activity induced in isolated ventricular muscles of the rabbit. Acta Anaesthesiol Scand 1991; 35(5): 373-379.
16. Danielsson BR, Danielson M, Rundqvist E, Reiland S. Identical phalangeal defects induced by phenytoin and nifedipine suggest fetal hypoxia and vascular disruption behind phenytoin teratogenicity. Teratology 1992; 45(3): 247-258.
17. Richichi J, Vasilenko P. The effects of nifedipine on pregnancy outcome and morphology of the placenta, uterus, and cervix during late pregnancy in the rat. Am J Obstet Gynecol 1992; 167(3): 797-803.
18. Sorensen HT, Czeizel AE, Rockenbauer M, Steffensen FH, Olsen J. The risk of limb deficiencies and other congenital abnormalities in children exposed in utero to calcium channel blockers. Acta Obstet Gynecol Scand 2001; 80(5): 397-401.
19. Lydakis C, Lip GY, Beevers M, Beevers DG. Atenolol and fetal growth in pregnancies complicated by hypertension. Am J Hypertens 1999; 12(6): 541-547.
20. Magee LA, Duley L. Oral beta-blockers for mild to moderate hypertension during pregnancy. Cochrane Database Syst Rev 2003; Issue 3, CD002863. DOI: 10.1002/14651858.CD002863.
21. Easterling TR, Brateng D, Schmucker B, Brown Z, Millard SP. Prevention of preeclampsia: a randomized trial of atenolol in hyperdynamic patients before onset of hypertension. Obstet Gynecol 1999; 3 (5 Pt 1): 725-733.
22. Davis RL, Rubanowice D, McPhillips H, et al. Risks of congenital malformations and perinatal events among infants exposed to antidepressant medications during pregnancy. Pharmacoepidemiol Drug Safety 2007; 16(10): 1086-1094.
23. Platt R, Davis R, Finkelstein J, et al. Multicenter epidemiologic and health services research on therapeutics in the HMO Research Network CERT. Pharmacoepidemiol Drug Safety 2001; 10(5): 373-377.
24. Raebel MA, Ellis JL, Andrade SE. Evaluation of gestational age and admission date assumptions used to determine prenatal drug exposure from administrative data. Pharmacoepidemiol Drug Safety 2005; 14(12): 829-836.
25. Andrade SE, Raebel MA, Morse AN, et al. Use of prescription medications with a potential for fetal harm among pregnant women. Pharmacoepidemiol Drug Safety 2006; 15(8): 546-554.
26. Bricelj V. Use of adrenergic beta-blockers in pregnancy. Heart Views 1999; 1(4): 130-132.
27. Langdon D, Stanley C. Hypoglycemia in the Infant and Child. In Pediatric Endocrinology, Sperling MA (ed.). Elsevier Health Sciences: Philadelphia, PA, 2008; 889.
28. Boluyt N, van Kempen A, Offringa M. Neurodevelopment after neonatal hypoglycemia: a systematic review and design of an optimal future study. Pediatrics 2006; 117(6): 2231-2243.
29. Lucas A, Morley R, Cole TJ. Adverse neurodevelopmental outcome of moderate neonatal hypoglycaemia. Br Med J 1988; 297(6659): 1304-1308.
30. Zakhari S. Mechanism of action of calcium antagonists on myocardial and smooth muscle membranes. Drugs Exp Clin Res 1986; 12(9-10): 817-829.
31. Leonardi MR, Hankins GD. What's new in tocolytics. Clin Perinatol 1992; 19(2): 367-384.
32. Lovejoy F, Linden C. Acute Poison and Drug Overdose. In Harrison's Principles of Internal Medicine, Isselbacher KJ, Martin JB, Braunwald E, Fauci AS, Wilson JD Kasper DL et al. (eds.). McGraw Hill: New York, 1994; 2450.
33. Novotny E. Neonatal Seizures. In Principles and Practice of Pediatrics, Oski FA (ed.). JB Lippincott Company: Philadelphia, 1994; 357-362.
34. Karlsson K, Kjellmer I. The outcome of diabetic pregnancies in relation to the mother's blood sugar level. Am J Obstet Gynecol 1972; 112(2): 213-220.
35. Clancy RR. Summary proceedings from the neurology group on neonatal seizures. Pediatrics 2006; 117(3 Pt 2): S23-S27.
36. US Food and Drug Administration (2009 December 30). FDA, Health organizations to study safety of medications taken during pregnancy. Retrieved from.
37. Feibus KB. FDA's proposed rule for pregnancy and lactation labeling: improving maternal child health through well-informed medicine use. J Med Toxicol 2008; 4(4): 284-288.