This is the current release of the guideline.

According to the guideline developer, this guideline has been reviewed and is still considered to be current as of October 2006. This review involved new literature searches of electronic databases followed by expert committee review of new evidence that has emerged since the original publication date.

The quality of evidence ratings, I-III, and the definitions (Standard, Guideline, Practice Option, Practice Advisory) are defined at the end of the "Major Recommendations" field.

The guideline developers recognize the potential serious side effects that may exceed those of primary antiepileptic drugs; however, felbamate can be an effective antiepileptic drug and has important advantages if used in certain patient populations.

The following recommendations were made as an advisory:

1. Patients for whom risk/benefit ratio supports use because there is Class I evidence for benefit.
   1. Lennox–Gastaut patients over age 4 unresponsive to primary antiepileptic drugs.
   2. Intractable partial seizures in patients over 18 years of age who have failed standard antiepileptic drugs at therapeutic levels (monotherapy: data indicate a better risk/benefit ratio for felbamate used as monotherapy).
   3. Patients on felbamate more than 18 months.
2. Patients for whom the current risk/benefit assessment does not support the use of felbamate:
   1. New onset epilepsy in adults or children
   2. Patients who have experienced significant prior hematologic adverse events
   3. Patients in whom follow-up and compliance will not allow careful monitoring
   4. Patients unable to discuss risks/benefits (i.e., with mental retardation, developmental disability) and for whom no parent or legal guardian is available to provide consent
3. Patients in whom risk/benefit ratio is unclear and based on case reports and expert opinion (Class III) only, but under certain circumstances depending on the nature and severity of the patient’s seizure disorder, felbamate use may be appropriate:
   1. Children with intractable partial epilepsy
   2. Other generalized epilepsies unresponsive to primary agents
   3. Patients who experience unacceptable sedative or cognitive side effects with traditional antiepileptic drugs.
   4. Lennox–Gastaut syndrome under age 4 unresponsive to other antiepileptic drugs.

Risk management

1. As therapy continues, risk/benefit ratio should be constantly assessed.
2. Patients should be educated as to early signs of potentially serious hepatic and hematopoetic side effects. These signs are: easy bruising, prolonged excessive bleeding, change in skin color, fatigue, fever, change in stool color, change in the color of the whites of the eye.
3. Laboratory monitoring has not been proved efficacious, but the manufacturer (Carter-Wallace), in conjunction with the U.S. Food and Drug Administration (FDA), suggests liver function tests at baseline and every 1 to 2 weeks for the first year of therapy, and also notes that complete blood count may identify hematologic changes before symptoms occur. There is no evidence that such monitoring will prevent adverse outcomes. After the first year, the risk of aplastic anemia drops and the need for ongoing laboratory screening is even less clear.
4. Even though individual clinical practice may vary, patients should be advised of the manufacturer’s recommendations.

Definitions:

Quality of evidence ratings

Class I: Well-designed, prospective, blinded, controlled studies.

Class II: Well-designed clinical studies, such as case control, cohort studies, etc.

Class III: Evidence provided by expert opinion, nonrandomized historic controls, or case reports of one or more.

Definitions:

Standard: A principle for patient management that reflects a high degree of clinical certainty (usually this requires Class I evidence that directly addresses the clinical question, or overwhelming Class II evidence when circumstances preclude randomized clinical trials).

Guideline: A recommendation for patient management that reflects moderate clinical certainty (usually this requires Class II evidence or a strong consensus of Class III evidence).

Practice option: A strategy for patient management for which the clinical utility is uncertain (inconclusive or conflicting evidence or opinion).

Practice Advisory: A practice recommendation for emerging and/or newly approved therapies or technologies based on evidence from at least one Class I study. The evidence may demonstrate only a modest statistical effect or limited (partial) clinical response, or significant cost-benefit questions may exist. Substantial (or potential) disagreement among practitioners or between payers and practitioners may exist.

None provided

The recommendations are based on a review of the literature. The type of supporting evidence is identified and graded for the use of felbamate in the treatment of patients with intractable epilepsy (See "Major Recommendations" field).

Both Class I and Class III evidence was found to support recommendations for the efficacy of felbamate in various types of epilepsy. Class I evidence was found for risks for side effects, and Class III evidence only was found for serious risks of felbamate.

Not applicable: The guideline was not adapted from another source.

1999 May (reviewed 2006 Oct)

American Academy of Neurology - Medical Specialty Society
American Epilepsy Society - Disease Specific Society

American Academy of Neurology (AAN)

Quality Standards Subcommittee

American Academy of Neurology Quality Standards Subcommittee Members: Gary Franklin, MD, MPH (Co-chair); Catherine A. Zahn, MD (Co-chair); Milton Alter, MD, PhD; Stephen Ashwal, MD; John Calverley, MD; Richard Dubinsky, MD; Jacqueline French, MD; Michael K. Greenberg, MD; Gary Gronseth, MD; Deborah Hirtz, MD; Robert G. Miller, MD; and James Stevens, MD

Drs French and Faught have received research support from Carter–Wallace Pharmaceuticals. Drs French, Faught, and Smith are past members of a speakers’ bureau supported by Carter– Wallace. Dr. Faught has been a consultant for Carter–Wallace.

This is the current release of the guideline.

According to the guideline developer, this guideline has been reviewed and is still considered to be current as of October 2006. This review involved new literature searches of electronic databases followed by expert committee review of new evidence that has emerged since the original publication date.

• Practice statement definitions. St. Paul (MN): American Academy of Neurology.
• Practice statement development. St. Paul (MN): American Academy of Neurology.

None available

This summary was completed by ECRI on February 12, 2002. The information was verified by the guideline developer as of March 29, 2002.

This NGC summary is based on the original guideline, which is copyrighted by the American Academy of Neurology.