Table 1.
Study | Country | Included years | Exposed to carbamazepine monotherapy | ||
---|---|---|---|---|---|
Number | Malformed | Rate (95% CI) | |||
Samrén 199714 | Berlin and Magdeburg, Germany; Helsinki, Finland; Rotterdam, Netherlands; epilepsy institutes | 1972-90 | 280 | 22 | 7.9 (5.2 to 11.6) |
Diav-Citrin 200111 | Israeli Teratogen Information Service | Jan 1989-March 1999 | 108 | 6 | 5.6 (2.6 to 11.8) |
Kaaja 200312 | Finland, Helsinki | Jan 1980-Sep 1998 | 363 | 10 | 2.8 (1.5 to 5.0) |
Sabers 200413 | 6 hospitals, Denmark, | Sep 1996-May 2000 | 18 | 0 | 0 (0.0 to 17.6) |
Wide 20045 | Sweden | Jul 1995-Dec 2001 | 703 | 28 | 4.0 (2.8 to 5.7) |
Meador 20062 | 25 epilepsy centres, UK and US | Oct 1999-Feb 2004 | 110 | 5 | 4.5 (2.0 to 10.2) |
Morrow 20063 | Pregnancy registry, UK | Dec 1996-March 2005 | 900 | 20 | 2.2 (1.4 to 3.4) |
Vajda 20074 | Pregnancy registry, Australia | Jul 1999-Oct 2002 | 198 | 10 | 5.1 (2.8 to 9.0) |
Total | — | 1972-2005 | 2680 | 101 | 3.8 (3.1 to 4.6) |
Major according to EUROCAT* | — | — | 2680 | 89 | 3.3 (2.7 to 4.2) |
*According to EUROCAT major congenital malformation classification (based on ICD-10) 12 were only minor malformations and were therefore excluded.