The FDA issued the following warning in September 2006:
New information suggests that babies exposed to Lamictal during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate. Babies born with cleft lip or cleft palate have a gap in the upper lip or roof of the mouth.Most Common Side Effects of LamictalIf you take Lamictal and are pregnant or are thinking of becoming pregnant, talk with your doctor. Lamictal is used for seizures or bipolar disorder, serious conditions that need treatment even during pregnancy. Do not start or stop using Lamictal without talking to your doctor.
More research is needed to be sure about this possibly increased chance of cleft lip or cleft palate in babies born to mothers who take Lamictal.
Negative side effects were much more common in clinical trials using epilepsy patients than in those using bipolar patients. In the epilepsy trials the most common side effects of Lamictal were:
- Dizziness
- Double vision
- Headache
- Unsteady gait
- Blurred vision
- Nausea
- Sleepiness
- Upper respiratory infection
- Vomiting
For more, see Lamictal Side Effects from our Side Effects Library.
Disclaimer: This is not intended to be all-inclusive or to replace information provided by your doctor or with the prescription from the manufacturer.
References:
US Food and Drug Administration. Approved Label for Lamictal. 9-25-06.
US Food and Drug Administration. FDA Alert: Lamotrigine (marketed as Lamictal) Information. September 2006.
Calabrese, J.R., et al. A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently depressed patients with bipolar I disorder. J Clin Psychiatry. 2003 Sep;64(9):1013-24.
Bowden, C.L., et al. A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently manic or hypomanic patients with bipolar I disorder. Arch Gen Psychiatry. 2003 Apr;60(4):392-400.
