MEPHOBARBITAL

Drugs in Pregnancy and Lactation.

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Name: MEPHOBARBITAL
Class: Anticonvulsant/Sedative
Risk Factor:    DM

Fetal Risk Summary

Mephobarbital (methylphenobarbital; methylphenobarbitone) is a bartiturate with sedative, hypnotic, and anticonvulsant properties. Although specific information is not available, barbiturates readily cross the placenta with highest concentrations in the placenta, fetal liver and brain (1). The drug is demethylated by the liver to phenobarbital (see Phenobarbital).

The Collaborative Perinatal Project monitored 50,282 mother-child pairs, 8 of which had 1st trimester exposure to mephobarbital (2). No evidence was found to suggest a relationship to large categories of major or minor malformations or to individual defects. Hemorrhagic disease and barbiturate withdrawal in the newborn are theoretically possible, although they have not been reported in humans with mephobarbital.

A 2000 study, using data from the MADRE (an acronym for MAlformation and DRug Exposure) surveillance project, assessed the human teratogenicity of anticonvulsants (3). Among 8005 malformed infants, cases were defined as infants with a specific malformation, whereas controls were infants with other anomalies. Of the total group, 299 were exposed in the 1st trimester to anticonvulsants. Among these, exposure to monotherapy occurred in the following: phenobarbital (N=65), methobarbital (N=10), carbamazepine (N=46), valproic acid (N=80), phenytoin (N=24), and other agents (N=16). Statistically significant associations (CI not overlapping 1 and pŁ(0.05) were found between methobarbital monotherapy and cardiac defects (N=4) and cleft lip/palate (N=4). When all 1st trimester exposures (mono- and polytherapy) were evaluated, a significant association was found with cleft lip/palate (N=4). Although the study confirmed some previously known associations, several new associations with anticonvulsants were discovered and require independent confirmation (see also Carbamazepine, Phenobarbital, Phenytoin, and Valproic Acid) (3).

Breast Feeding Summary

See Phenobarbital.

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References

  1. Product information. Mebaral. Sanofi-Synthelabo, 2001.
  2. Heinonen O, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, 1977:336.
  3. Arpino C, Brescianini S, Robert E, Castilla EE, Cocchi G, Cornel MC, de Vigan C, Lancaster PAL, Merlob P, Sumiyoshi Y, Zampino G, Renzi C, Rosano A, Mastroiacovo P. Teratogenic effects of antiepileptic drugs: use of an international database on malformations and drug exposure (MADRE). Epilepsia 2000;41:1436–43.

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