Very few people have serious reactions to Trileptal. If you take it, you should be aware of them, however, so you and your family can recognize them.

Here's a list of warning signs that may possibly be the start of a serious problem. If you notice any of these things, call your doctor right away:

• Severe Skin reactions (see below)
• Rash (possible allergic reaction)
• Other severe allergic reactions
• Swelling of the throat, lips and eyelids, which could occur after the first or later doses. These reactions can be life-threatening, and people who have had these reactions should not take the drug again.
• Vomiting
• Increased seizures
• Frequent headaches or a headache that doesn't go away
• Sluggishness
• Confusion

Severe Skin Reactions
As of April 19, 2005 the FDA and Novartis pharmaceuticals (the manufacturers of Trileptal) issued a new warning regarding Trileptal. Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with Trileptal use. SJS and TEN may start with fever and flu-like symptoms. Then, a rash develops, with or without ulcers of the mucous membranes,that quickly progresses to blisters that burn and are painful.

The most common time of onset after first dosage of Tripetal was 19 days. Such serious skin reactions may be life-threatening, and some patients have required hospitalization with very rare reports of fatal outcome. Therefore, if you have any skin reactions upon taking Trileptal, you should seek immediate medical attention.

Hyponatremia
The last five items in this list could occur if you have a low level of sodium (salt) in your blood, a condition called hyponatremia. This condition has been reported in about 1 in every 40 patients taking Trileptal. It has occurred most often during the first 3 months of treatment, but in some cases it has been discovered much later. Usually it is not serious. You might even have it without noticing anything wrong. But now and then it does cause major problems, so your doctor may want to check the sodium level in your blood to see if this is happening to you.

It is important to remember that only a tiny number of people who take Trileptal have any serious problems.

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10. The FDA has provided the following information for patients, family members, and caregivers at www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

• Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
• Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
• Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
• Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Reviewed July 2008 by Steven C. Schachter, MD, epilepsy.com Editorial Board.