Consumer Alert: Tegretol Increases Risk of Spina Bifida

December 6, 2010 – According to a new study published in the British Medical Journal, epilepsy drug Tegretol has been linked to an increased risk of spina bifida in babies born to mothers who have been prescribed the medication.

The study looked at eight cohort studies of 2,680 pregnancies where the women were exposed to carbamazepine, which is marketed as Tegretol, Carbatrol, Epitol and Equetrol. Overall, 3.3% of women who took the drug in the first trimester gave birth to children with birth defects. They determined that Tegretol side effects during pregnancy were associated with a 2.6 times greater risk of having a child with spina bifida than women who were not exposed to carbamazepine.

The use of other valproate epilepsy drugs during pregnancy – such as Depakote, Depacon, Depakine and Stavzor – have also been associated with an increased risk of birth defects including (but not limited to):

• spina bifida
• cleft palate
• abnormal skull development
• malformed limbs
• holes in the heart
• urinary tract problems

What is Spina Bifida?

When a baby is growing inside its mother, sometimes part of the spinal cord and spine don’t grow the way they should. This leaves an opening where the spinal cord may protrude outside the body. When this happens, a baby is born with spina bifida, a term that means “split or open spine.”