Most people who take Felbatol (felbamate) have no side effects or mild side effects that go away with no lasting harm. But a few people (about 1 in 4,500) have had serious reactions. Here's a list of symptoms that may be the start of one of these problems. If you notice any of these symptoms, call your doctor right away:

• bleeding (for example, in the nose, gums, or skin)
• easy bruising
• unusual tiredness or weakness
• shortness of breath
• rash
• rapid heart rate
• high fever, shaking and chills

The risk for liver failure and a serious blood disease called aplastic anemia are higher for people taking Felbatol than for people in general. It is extremely important that you consult your doctor immediately if you experience any of the above symptoms. The doctor will probably recommend blood tests at regular intervals to look for signs of one of these serious disorders, even though early detection is no guarantee that the disorder will not become life-threatening.

Persons with blood disorders, liver disorders, or disorders of the immune system may have an even higher risk of a serious reaction to Felbatol. Be sure to tell your doctor if you have had any disorders of this kind.

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.