Q: My 6-year-old nephew is currently taking 150 mg of Lamictal per day (down from 200 mg per day) and has been for approximately eight months. He is having behavioral problems and emotional lability. I have recently heard that Lamictal has not been approved for use in children. His parents were not informed of this. Is this true? What is your opinion of the use of Lamictal in young children? Thank you for your consideration.
A: There are actually few medications that are FDA approved for children, and most received this through grandfathering rather than clinical trials. If you examine the package insert, phenytoin (Dilantin), phenobarbital, and valproate (Depakote) do not address use in children, and Tegretol is approved down to age 6. The rest of the anticonvulsants do not have a specific FDA approval for children, with the exception of felbamate (Felbatol). This does not mean that they are not useful, and your physician is certainly allowed to use them. Lamotrigine (Lamictal) appears to be a useful drug in pediatric epilepsy, because it seems to be effective for a wide variety of seizure types seen in children. It has not yet received FDA approval. There is a concern of serious rash, especially in children, that may be as high as 1 in 50 to 100.
All seizure medications can potentially cause behavioral changes, especially phenobarbital. If you believe this is a possibility in you nephew, you should discuss this with his physician.