A triazine anticonvulsant - It is used to control seizures in adults and children with epilepsy
FDA Alerts
Special Alerts:
[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.
Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
The drugs included in the analyses include (some of these drugs are also available in generic form):
Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)
Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.
[Posted 09/29/2006] The FDA notified healthcare professionals and patients of new preliminary information from the North American Antiepileptic Drug Pregnancy Registry that suggests that babies exposed to lamotrigine (Lamictal), indicated to treat seizures and bipolar disorder, during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate.
Women who are pregnant and taking lamotrigine or who are thinking about taking this medication are urged to not start or stop taking the medication without first talking to their physician. More research is needed to be sure about the possibility of the increased chance of cleft lip or cleft palate developing in babies of pregnant women who take lamotrigine. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Lamictal, http://www.fda.gov/cder/drug/InfoSheets/patient/lamotriginePIS.htm and http://www.fda.gov/cder/drug/InfoSheets/HCP/lamotrigineHCP.htm.
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not chew these tablets. If this medicine upsets your stomach, take it with food or milk. Take your doses at regular intervals. Do not take your medicine more often than directed.
A special MedGuide will be given to you by the pharmacist with each new prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. If you take this medicine for seizures, wear a Medic Alert bracelet or necklace. Carry an identification card with information about your condition, medicines, and doctor or health care professional.
It is important to take this medicine exactly as directed. When first starting treatment, your dose will need to be adjusted slowly. It may take weeks or months before your dose is stable. You should contact your doctor or health care professional if your seizures get worse or if you have any new types of seizures. Do not stop taking this medicine unless instructed by your doctor or health care professional. Stopping your medicine suddenly can increase your seizures or their severity.
Contact your doctor or health care professional right away if you develop a rash while taking this medicine. Rashes may be very severe and sometimes require treatment in the hospital. Deaths from rashes have occurred. Serious rashes occur more often in children than adults taking this medicine. It is more common for these serious rashes to occur during the first 2 months of treatment, but a rash can occur at any time.
You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.
If you are taking this medicine for bipolar disorder, it is important to report any changes in your mood to your doctor or health care professional. If your condition gets worse, you get mentally depressed, feel very hyperactive or manic, have difficulty sleeping, or have thoughts of hurting yourself or committing suicide, you need to get help from your health care professional right away. If you are a caregiver for someone taking this medicine for bipolar disorder, you should also report these behavioral changes right away. The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.
Last Updated: July 09, 2009
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