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Midazolam Pregnancy and Breastfeeding Warnings

Midazolam is also known as: Versed

Midazolam Pregnancy Warnings

Midazolam has been assigned to pregnancy category D by the FDA. An increased risk of congenital malformations in humans has been suggested with use of other benzodiazepines. In addition, respiratory depression, decreased body temperature, decreased body tone and decreased arm recoil have been reported in the offspring of women who received midazolam before Cesarean section. Midazolam use is considered contraindicated during pregnancy.

The pharmacokinetic disposition of midazolam has been reported in pregnant women scheduled for elective Cesarean section. In such women, the volume of distribution averages 1.0 L/kg, the plasma clearance ranges from 11.5 to 13.9 mL/min/kg and the elimination half-life ranges from 0.8 to 1.7 hours. One report has suggested that, unlike women treated with diazepam, some women treated with midazolam as an adjuvant to regional anesthesia may not be able to recall the births of their babies.

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Midazolam Breastfeeding Warnings

One small study has reported the pharmacokinetic data of five lactating women who underwent premedication with midazolam before induction of anesthesia. In 24 hours of milk collection, an average of 0.005% (0.002% to 0.013%) of the maternal midazolam was collected in the milk representing an average of 0.009% of the elimination clearance of the drug. The author of the study concluded that the amount of midazolam excreted into the milk within 24 hours of induction of anesthesia provided insufficient justification to interrupt breast-feeding.

Midazolam is excreted into human milk in very small amounts. Sedation is a theoretic concern but has not been reported. Midazolam is described by the American Academy of Pediatrics as a drug "whose effect on nursing infants is unknown but may be of concern".

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References for pregnancy information

  1. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  2. Wilson CM, Dundee JW, Moore J, Howard PJ, Collier PS "A comparison of the early pharmacokinetics of midazolam in pregnant and nonpregnant women." Anaesthesia 42 (1987): 1057-62
  3. Kanto J, Sjovall S, Erkkola R, Himberg JJ, Kangas L "Placental transfer and maternal midazolam kinetics." Clin Pharmacol Ther 33 (1983): 786-91
  4. Bach V, Carl P, Ravlo O, Crawford ME, Jensen AG, Mikkelsen BO, Crevoisier C, Heizmann P, Fattinger K "A randomized comparison between midazolam and thiopental for elective cesarean section anesthesia: III. Placental transfer and elimination in neonates." Anesth Analg 68 (1989): 238-42
  5. Kanto J, Aaltonen L, Erkkola R, Aarimaa L "Pharmacokinetics and sedative effect of midazolam in connection with caesarean section performed under epidural analgesia." Acta Anaesthesiol Scand 28 (1984): 116-8
  6. Ravlo O, Carl P, Crawford ME, Bach V, Mikkelsen BO, Nielsen HK "A randomized comparison between midazolam and thiopental for elective cesarean section anesthesia: II. Neonates." Anesth Analg 68 (1989): 234-7
  7. Camann W, Cohen MB, Ostheimer GW "Is midazolam desirable for sedation in parturients." Anesthesiology 65 (1986): 441

References for breastfeeding information

  1. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  2. Nitsun M, Szokol JW, Saleh HJ, et al. "Pharmacokinetics of midazolam, propofol, and fentanyl transfer to human breast milk." Clin Pharmacol Ther 79 (2006): 549-557
  3. Matheson I, Lunde PK, Bredesen JE "Midazolam and nitrazepam in the maternity ward: milk concentrations and clinical effects." Br J Clin Pharmacol 30 (1990): 787-93

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