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Diagnosis & Treatment > Seizure Medications > Felbatol® > Serious side effects of Felbatol
 

Serious side effects of Felbatol

Clinical experience with Felbatol following its approval by the FDA in the U.S. showed a significant risk of fatal aplastic anemia and liver failure. As a result, the use of Felbatol is now largely restricted to patients with Lennox-Gastaut syndrome for whom the benefits of treatment outweigh the very significant risks.

Patients should be told to call their doctor right away if they develop any of the following problems:

  • 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 chance that a particular patient will develop liver failure or aplastic anemia while taking Felbatol appears to be approximately 1 out of 4,500.

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.

When a patient presents with a serious and/or unexpected adverse reaction from a medication or device, you should consider reporting this event to Medwatch (http://www.fda.gov/medwatch/report/hcp.htm). To download Medwatch reporting forms click here (http://www.fda.gov/medwatch/getforms.htm).