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Labetalol Pregnancy and Breastfeeding Warnings

Labetalol is also known as: Normodyne, Trandate

Labetalol Pregnancy Warnings

Labetalol has been used for the treatment of hypertension during human pregnancy because of the paucity of adverse side effects on the fetus and neonate. Furthermore, labetalol does not appear to compromise uterine blood flow or inhibit uterine contractions despite an effective reduction in maternal systemic blood pressure. In one study of 42 women with moderate to severe pregnancy-induced hypertension, labetalol was an effective antihypertensive agent and did not significantly affect umbilical artery flow velocity. Three studies regarding the side effects or teratogenicity of labetalol are notable. Data from the Michigan Medicaid Birth Defects study have revealed an association between the use of labetalol and congenital abnormalities (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). This was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 29 were exposed to labetalol at some time during the first trimester, and 143 were exposed to the drug at any time during pregnancy. Of the 29 pregnancies, there were 4 total birth defects (1 was expected). There were no observations of cardiovascular defects, cleft palate, spina bifida, polydactyly, limb reduction, or hypospadias. These data are consistent with an association between the use of labetalol and birth defects, although other factors, including underlying disease(s) of the mother are not accounted for. In one study, significantly more infants whose mothers received labetalol were growth retarded than in those infants whose mothers did not receive the drug. In another study, intrauterine growth retardation was detected in preeclamptic patients who had received labetalol. While labetalol crosses the placenta, side effects in the fetus or neonate are not expected. Rare cases of neonatal hypoglycemia, bradycardia, and hypotension have been reported and may be more likely with prolonged maternal labetalol treatment. The use of glucagon at doses of 300 to 600 mcg/kg have been suggested for treating neonatal low output congestive heart failure after maternal labetalol therapy.

Labetalol has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity, although an increased incidence of fetal resorption was demonstrated in some studies at doses approximating the maximum recommended human dose. There are no controlled data in human pregnancy. Labetalol should only be given during pregnancy when benefit outweighs risk.

See references

Labetalol Breastfeeding Warnings

Labetalol is excreted into human milk in small amounts. Adverse effects in nursing infants are unlikely. Labetalol is considered compatible with breast-feeding by the American Academy of Pediatrics.

As with other beta-blockers, it is recommended that nursing infants who are potentially exposed to labetalol be observed for signs of beta-blockade during and immediately after breast-feeding. Signs of beta-blockade include bradycardia and hypotension.

See references

References for pregnancy information

  1. Yeleswaram K, Rurak DW, Kwan E, Hall C, Doroudian A, Wright MR, Abbott FS, Axelson JE "Transplacental and nonplacental clearances, metabolism and pharmacodynamics of labetalol in the fetal lamb after direct intravenous administration." J Pharmacol Exp Ther 267 (1993): 425-31
  2. Frishman WH, Chesner M "Beta-adrenergic blockers in pregnancy." Am Heart J 115 (1988): 147-52
  3. Riley AJ "Clinical pharmacology of labetalol in pregnancy." J Cardiovasc Pharmacol 3 (1981): s53-9
  4. Lamming GD, Pipkin FB, Symonds EM "Comparison of the alpha and beta blocking drug, labetalol, and methyl dopa in the treatment of moderate and severe pregnancy-induced hypertension." Clin Exp Hypertens 2 (1980): 865-95
  5. Rogers RC, Sibai BM, Whybrew WD "Labetalol pharmacokinetics in pregnancy-induced hypertension." Am J Obstet Gynecol 162 (1990): 362-6
  6. Thulesius O, Lunell NO, Ibrahim M, Moberger B, Angilivilayil C "The effect of labetalol on contractility of human myometrial preparations." Acta Obstet Gynecol Scand 66 (1987): 237-40
  7. Lunell NO, Nylund L, Lewander R, Sarby B "Acute effect of an antihypertensive drug, labetalol, on uteroplacental blood flow." Br J Obstet Gynaecol 89 (1982): 640-4
  8. "Product Information. Normodyne (labetalol)." Schering Laboratories, Kenilworth, NJ.
  9. Plouin PF, Breart G, Maillard F, Papiernik E, Relier JP, The Labetalol Methyldopa Study Group "Comparison of antihypertensive efficacy and perinatal safety of labetalol and methyldopa in the treatment of hypertension in pregnancy: a randomized controlled trial." Br J Obstet Gynaecol 95 (1988): 868-76
  10. Crooks BNA, Deshpande SA, Hall C, Platt MPW, Milligan DWA "Adverse neonatal effects of maternal labetalol treatment." Arch Dis Child 79 (1998): f150-1
  11. Cruickshank DJ, Robertson AA, Campbell DM, MacGillivray I "Does labetalol influence the development of proteinuria in pregnancy hypertension? A randomised controlled study." Eur J Obstet Gynecol Reprod Biol 45 (1992): 47-51
  12. Nylund L, Lunell NO, Lewander R, et al "Labetalol for the treatment of hypertension in pregnancy: pharmacokinetics and effects on the uteroplacental blood flow." Acta Obstet Gynecol Scand Suppl 118 (1984): 71-3
  13. Mahmoud TZ, Bjornsson S, Calder AA "Labetalol therapy in pregnancy induced hypertension: the effects on fetoplacental circulation and fetal outcome." Eur J Obstet Gynecol Reprod Biol 50 (1993): 109-13
  14. Olsen KS, Beier-Holgersen R "Hemodynamic collapse following labetalol administration in preeclampsia." Acta Obstet Gynecol Scand 71 (1992): 151-2
  15. Sibai BM, Gonzalez AR, Mabie WC, Moretti M "A comparison of labetalol plus hospitalization versus hospitalization alone in the management of preeclampsia remote from term." Obstet Gynecol 70 (1987): 323
  16. Rubin PC, Butters L, Kelman AW, et al "Labetalol disposition and concentration-effect relationships during pregnancy." Br J Clin Pharmacol 15 (1983): 465-70
  17. Hjertberg R, Faxelius G, Lagercrantz H "Neonatal adaptation in hypertensive pregnancy--a study of labetalol vs hydralazine treatment." J Perinat Med 21 (1993): 69-75

References for breastfeeding information

  1. Lunell NO, Kulas J, Rane A "Transfer of labetalol into amniotic fluid and breast milk in lactating women." Eur J Clin Pharmacol 28 (1985): 597-9
  2. "Product Information. Normodyne (labetalol)." Schering Laboratories, Kenilworth, NJ.
  3. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50

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