Skip to main content

Mephobarbital Pregnancy and Breastfeeding Warnings

Brand names: Mebaral

Mephobarbital Pregnancy Warnings

Mephobarbital has been assigned to pregnancy category D by the FDA. A higher than expected incidence of fetal abnormalities have been reported with maternal consumption of barbiturates. Neonatal barbiturate withdrawal symptoms have been reported in infants whose mothers took phenobarbital during pregnancy. (Phenobarbital is the major metabolite of mephobarbital.) There are no controlled data in human pregnancy. Mephobarbital should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Barbiturates readily cross the placental barrier and are distributed throughout the fetal tissues with the highest concentrations found in the placenta, fetal liver, and brain. Fetal blood levels have been reported to approach maternal blood levels following parenteral administration.

An increased risk of congenital malformations has been associated with use of anticonvulsants agents during pregnancy. Anomalies associated with anticonvulsant use in pregnancy include neural tube defects, cleft lips, cleft palates, cardiac defects, and microcephaly.

Physicians are encouraged to register patients before fetal outcome is known (e.g., ultrasound, results of amniocentesis, etc) into the Antiepileptic Drug (AED) Pregnancy Registry at 1-888-233-2334 or 1-888-AED-AED4. This is an ongoing study at the Massachusetts General Hospital/Harvard Medical School. This study is designed to monitor the outcomes of pregnant women exposed to antiepileptic drugs in order to determine which therapies are associated with increased risk.

See references

Mephobarbital Breastfeeding Warnings

Mephobarbital is excreted into human milk in small amounts. Because of the prolonged half-life of mephobarbital in neonates, accumulation of the drug may occur and neonatal serum levels can potentially exceed maternal serum levels. Sedation and lethargy have been reported in nursing infants with the use of barbiturates. The American Academy of Pediatrics has not issued any statements specifically regarding mephobarbital. However, phenobarbital is the major metabolite of mephobarbital. The American Academy of Pediatrics classifies phenobarbital as a drug which has "caused significant effects in some nursing infants and should be given to nursing mothers with caution".

See references

References for pregnancy information

  1. Dravet C, Julian C, Legras C, Magaudda A, Guerrini R, Genton P, Soulayrol S, Giraud N, Mesdjian E, Trentin G, et al. (1992) "Epilepsy, antiepileptic drugs, and malformations in children of women with epilepsy: a French prospective cohort study." Neurology, 42, p. 75-82
  2. Yerby MS, Leavitt A, Erickson DM, McCormick KB, Loewenson RB, Sells CJ, Benedetti TJ (1992) "Antiepileptics and the development of congenital anomalies." Neurology, 42, p. 132-40
  3. Lund A, Gormsen H (1985) "The role of antiepileptics in sudden death in epilepsy." Acta Neurol Scand, 72, p. 444-6
  4. (2001) "Product Information. Phenobarbital (phenobarbital)." Lilly, Eli and Company
  5. Waters CH, Belai Y, Gott PS, Shen P, Degiorgio CM (1994) "Outcomes of pregnancy associated with antiepileptic drugs." Arch Neurol, 51, p. 250-3
  6. Koren G, Pastuszak A, Ito S (1998) "Drugs in pregnancy." N Engl J Med, 338, p. 1128-37
  7. (2001) "Product Information. Mebaral (mephobarbital)." Sanofi Winthrop Pharmaceuticals
  8. Freudenthal RI, Carroll FI (1973) "Metabolism of certain commonly used barbiturates." Drug Metab Rev, 2, p. 265-78

References for breastfeeding information

  1. Roberts RJ, Blumer JL, Gorman RL, et al. (1989) "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics, 84, p. 924-36
  2. (2001) "Product Information. Phenobarbital (phenobarbital)." Lilly, Eli and Company
  3. Committee on Drugs, 1992 to 1993 (1994) "The transfer of drugs and other chemicals into human milk." Pediatrics, 93, p. 137-50
  4. (2001) "Product Information. Mebaral (mephobarbital)." Sanofi Winthrop Pharmaceuticals
  5. Freudenthal RI, Carroll FI (1973) "Metabolism of certain commonly used barbiturates." Drug Metab Rev, 2, p. 265-78

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer