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Risk of major congenital malformation and congenital heart defects associated with phenobarbital monotherapy.
| Study | CM (n) | Cardiac malformations | % of cardiac malformations (cases/n) | Ref. |
|---|---|---|---|---|
| Samrén (1999)† | 3 | 2 | 66.67 | [12] |
| Holmes (2001) | 3 | 2 | 66.67 | [10] |
| Holmes (2004) | 5 | 3 | 60.00 | [29] |
| Thomas (2008) | NA | Three out of 43 monotherapy exposures | [18] |
One cardiac defect was associated with an aberrant chromosome.
CM: Congenital malformation; NA: Not available.
