Lamictal Carries Major WarningsThe first Black Box Warning on the Lamictal label contains the information that Lamictal can cause dangerous, even fatal rashes. The warning says that Lamictal treatment should be discontinued at the first sign of any rash.
Other Major Precautions and Warnings
- Unless rash or hypersensitivity reactions appear, Lamictal should not be discontinued abruptly, but should be tapered off over a period of at least two weeks to help avoid the risk of seizures.
- Dosage adjustment will be necessary in most patients who start or stop taking oral contraceptives (birth control pills) containing estrogen while taking Lamictal.
- The safety and effectiveness of Lamictal in patients under 18 with mood disorders have not been established.
- Breast-feeding while taking Lamictal is not recommended.
Possibility of Birth Defects When Using LamictalThe 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.
If 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.
Most Common Side Effects of LamictalNegative 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:
- Double vision
- Unsteady gait
- Blurred vision
- Upper respiratory infection
Disclaimer: This is not intended to be all-inclusive or to replace information provided by your doctor or with the prescription from the manufacturer.
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.