Skip to Content

Mephobarbital Pregnancy and Breastfeeding Warnings

Mephobarbital is also known as: Mebaral

Mephobarbital Pregnancy Warnings

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.

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.

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

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. Freudenthal RI, Carroll FI "Metabolism of certain commonly used barbiturates." Drug Metab Rev 2 (1973): 265-78
  3. "Product Information. Phenobarbital (phenobarbital)." Lilly, Eli and Company, Indianapolis, IN.
  4. "Product Information. Mebaral (mephobarbital)" Sanofi Winthrop Pharmaceuticals, New York, NY.
  5. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.