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## Complete Summary

#### GUIDELINE TITLE

Efficacy and tolerability of the new antiepileptic drugs I: treatment of
new onset epilepsy: report of the Therapeutics and Technology Assessment
Subcommittee and Quality Standards Subcommittee of the American Academy
of Neurology and the American Epilepsy Society.

#### BIBLIOGRAPHIC SOURCE(S)

French JA, Kanner AM, Bautista J, Abou-Khalil B, Browne T, Harden CL,
Theodore WH, Bazil C, Stern J, Schachter SC, Bergen D, Hirtz D,
Montouris GD, Nespeca M, Gidal B, Marks WJ Jr, Turk WR, Fischer JH,
Bourgeois B, et al. Efficacy and tolerability of the new antiepileptic
drugs I: treatment of new onset epilepsy: report of the Therapeutics and
Technology Assessment Subcommittee and Quality Standards Subcommittee of
the American Academy of Neurology and the AES. Neurology 2004 Apr
27;62(8):1252-60. \[21 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15111659)

#### GUIDELINE STATUS

This is the current release of the guideline.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [December 12, 2007,
    Carbamazepine](http://www.fda.gov/medwatch/safety/2007/safety07.htm#carbamazepine):
    The U.S. Food and Drug Administration (FDA) has provided
    recommendations for screening that should be performed on specific
    patient populations before starting treatment with carbamazepine.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

New onset partial and generalized epilepsies

#### GUIDELINE CATEGORY

Assessment of Therapeutic Effectiveness\
Treatment

#### CLINICAL SPECIALTY

Neurology\
Pediatrics\
Pharmacology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

To assess the evidence demonstrating efficacy, tolerability, and safety
of seven new antiepileptic drugs (AEDs) (gabapentin, lamotrigine,
topiramate, tiagabine, oxcarbazepine, levetiracetam, and
zonisamide---reviewed in the order in which these agents received
approval by the US Food and Drug Administration) in the treatment of
children and adults with newly diagnosed partial and generalized
epilepsies

#### TARGET POPULATION

Children and adults with newly diagnosed partial and generalized
epilepsies

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Treatment**

1.  Gabapentin (Neurontin)

2.  Lamotrigine (Lamictal)

3.  Topiramate (Topamax)

4.  Tiagabine (Gabitril)

5.  Oxcarbazepine (Trileptal)

6.  Levetiracetam (Keppra)

7.  Zonisamide (Zonegran)

#### MAJOR OUTCOMES CONSIDERED

-   Time to first seizure

-   Percentage of patients rendered seizure free

-   Time to exit of the study due to lack of efficacy or adverse events

-   Incidence of adverse events

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

A literature search was performed including MEDLINE and Current Contents
for relevant articles published between January 1987 and September 2001.
A second, manual search was performed by panel members, covering
September 2001 through May 2002. A manual search for class I articles
was then updated to include articles published through March 2003. In
addition, the Cochrane library of randomized controlled trials in
epilepsy was searched in September 2002, and any appropriate articles
identified were added to the review.

**Criteria for Selection of Articles**

The literature search identified all papers that included the terms
epilepsy and either gabapentin, lamotrigine, levetiracetam,
oxcarbazepine, tiagabine, topiramate, or zonisamide and satisfied the
following criteria: 1) relevant to the clinical questions of efficacy,
safety, tolerability, or mode of use; 2) human subjects only; 3) type of
studies: randomized controlled trials, cohort, case control,
observational, or case series; 4) all languages for randomized
controlled trials not available in English; and 5) relevant to patients
with newly diagnosed epilepsy.

**Exclusion Criteria**

Articles were excluded from further analysis if they were reviews or
meta-analyses, articles related to non-epilepsy uses of antiepileptic
drugs (AEDs) unless they describe relevant idiosyncratic reactions or
safety concerns, and articles on basic AED mechanisms.

#### NUMBER OF SOURCE DOCUMENTS

A total of 1,462 articles were identified: 240 on gabapentin, 433 on
lamotrigine, 244 on topiramate, 17 on levetiracetam, 212 on
oxcarbazepine, 177 on tiagabine, and 146 on zonisamide. Among these,
data were extracted for classification of evidence class from 353
articles: 91 on gabapentin, 63 on lamotrigine, 65 on topiramate, 46 on
tiagabine, 45 on oxcarbazepine, 33 on zonisamide, and 11 on
levetiracetam. Among these studies, there was one gabapentin class I
study, three class I or II studies with lamotrigine, two class I studies
with topiramate, and three class I studies and one class II study with
oxcarbazepine in patients with new-onset epilepsy.

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Rating of Therapeutic Article**

**Class I**: Prospective, randomized, controlled clinical trial (RCT)
with masked outcome assessment, in a representative population. The
following are required:

a.  Primary outcome(s) is/are clearly defined.

b.  Exclusion/inclusion criteria are clearly defined.

c.  Adequate accounting for dropouts and crossovers with numbers
    sufficiently low to have minimal potential for bias

d.  Relevant baseline characteristics are presented and substantially
    equivalent among treatment groups or there is appropriate
    statistical adjustment for differences.

**Class II**: Prospective matched group cohort study in a representative
population with masked outcome assessment that meets a--d above OR a RCT
in a representative population that lacks one criterion a--d.

**Class III**: All other controlled trials (including well-defined
natural history controls or patients serving as own controls) in a
representative population, where outcome assessment is independent of
patient treatment.

**Class IV**: Evidence from uncontrolled studies, case series, case
reports, or expert opinion.

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The panel assessed efficacy and dose-related side effects from
double-blind controlled studies with 20 or more patients. Safety data
were also derived from open trials and case reports.

Data for each antiepileptic drug (AED) were reviewed by three panel
members, with a different group assembled for each drug. These three
panelists classified each article as Class I through IV (See above
\"Rating Scheme for the Strength of the Evidence\"). Disagreements on
article classification were resolved by discussion and consensus.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Other

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

When formulating the recommendations the guideline developers considered
the *magnitude* of the effect (benefit or harm of therapy, accuracy of
tests, yield of studies) and the relative *value* of various outcomes.
Under most circumstances, there is a direct link between the level of
evidence used to formulate conclusions and the strength of the
recommendation. This linkage is illustrated in Appendix 9 of the 2004
AAN Guideline Process Manual (see Companion Documents field). Thus, an
\"established as\" (two class I) conclusion supports a \"should be
done\" (level A) recommendation; a \"probably effective\" (two class II)
conclusion supports a \"should be considered\" (level B) recommendation;
a \"possibly effective\" (two class III) conclusion supports a \"may be
considered\" recommendation. In those circumstances where the evidence
indicates that the intervention is not effective or useful, wording was
modified. For example, if multiple adequately powered class I studies
demonstrated that an intervention is not effective, the recommendation
read, \"should not be done.\"

There are important exceptions to the rule of having a direct linkage
between the level of evidence and the strength of recommendations. Some
situations where it may be necessary to break this linkage are listed
below:

-   A statistically significant but marginally important benefit of the
    intervention is observed

-   The intervention is exorbitantly costly

-   Superior and established alternative interventions are available

-   There are competing outcomes (both beneficial and harmful) that
    cannot be reconciled

Under such circumstances the guideline developers may have downgraded
the level of the recommendation.

Edlund W, Gronseth G, So Y, Franklin G. Clinical practice guideline
process manual. St. Paul (MN): American Academy of Neurology (AAN);
2004. 49 p.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Rating of Recommendations**

**A** = Established as effective, ineffective, or harmful for the given
condition in the specified population.

**B** = Probably effective, ineffective, or harmful for the given
condition in the specified population.

**C** = Possibly effective, ineffective, or harmful for the given
condition in the specified population.

**U** = Data inadequate or conflicting; given current knowledge,
treatment is unproven.

**Translation of Evidence to Recommendations**

**Level A** rating requires at least one convincing class I study or at
least two consistent, convincing class II studies.

**Level B** rating requires at least one convincing class II study or at
least three consistent class III studies.

**Level C** rating requires at least two convincing and consistent class
III studies.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Guidelines were approved by the Quality Standards Subcommittee (QSS) on
July 26, 2003, the Therapeutics and Technology Assessment Subcommittee
(TTA) on October 17, 2003, the Practice Committee on November 16, 2003,
and the American Academy of Neurology (AAN) Board of Directors on
January 18, 2004.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Definitions of the strength of the recommendations (A, B, C, U) and
classification of the evidence (Class I through Class IV) are provided
at the end of the \"Major Recommendations\" field.

**Efficacy and Tolerability of the New Antiepileptic Drugs (AEDs)
Compared with That of Older AEDs in Patients with Newly Diagnosed
Epilepsy**

1.  Patients with newly diagnosed epilepsy who require treatment can be
    initiated on standard AEDs such as carbamazepine, phenytoin,
    valproic acid, phenobarbital, or on the new AEDs lamotrigine,
    gabapentin, oxcarbazepine, or topiramate. Choice of AED will depend
    on individual patient characteristics (**Level A**).

> **Note**: At present, there is insufficient evidence to determine
> effectiveness in newly diagnosed patients for tiagabine, zonisamide,
> or levetiracetam

**Effectiveness of New AEDs in Adults or Children with Primary or
Secondary Generalized Epilepsy**

1.  Lamotrigine can be included in the options for children with newly
    diagnosed absence seizures (**Level B**).

> **Note**: At present there is insufficient evidence to determine
> effectiveness in newly diagnosed primary or secondary generalized
> epilepsy for topiramate, oxcarbazepine, tiagabine, zonisamide, or
> levetiracetam.

**Table: Summary of American Academy of Neurology (AAN) Evidence-Based
Guidelines Level A or B Recommendation for Use**

  ------------------------------------------------------------------------
  **Drug**         **Newly diagnosed monotherapy\     **Newly diagnosed\
                   partial/mixed**                    absence**
  ---------------- ---------------------------------- --------------------
  Gabapentin       Yes\*                              No

  Lamotrigine      Yes\*                              Yes\*

  Topiramate       Yes\*                              No

  Tiagabine        No                                 No

  Oxcarbazepine    Yes                                No

  Levetiracetam    No                                 No

  Zonisamide       No                                 No
  ------------------------------------------------------------------------

\* Not Food and Drug Administration-approved for this indication.

**[Definitions]{.underline}**:

**Rating of Recommendations**

**A** = Established as effective, ineffective, or harmful for the given
condition in the specified population.

**B** = Probably effective, ineffective, or harmful for the given
condition in the specified population.

**C** = Possibly effective, ineffective, or harmful for the given
condition in the specified population.

**U** = Data inadequate or conflicting; given current knowledge,
treatment is unproven.

**Translation of Evidence to Recommendations**

**Level A** rating requires at least one convincing class I study or at
least two consistent, convincing class II studies.

**Level B** rating requires at least one convincing class II study or at
least three consistent class III studies.

**Level C** rating requires at least two convincing and consistent class
III studies.

**Rating of Therapeutic Article**

**Class I**: Prospective, randomized, controlled clinical trial (RCT)
with masked outcome assessment, in a representative population. The
following are required:

a.  Primary outcome(s) is/are clearly defined.

b.  Exclusion/inclusion criteria are clearly defined.

c.  Adequate accounting for dropouts and crossovers with numbers
    sufficiently low to have minimal potential for bias

d.  Relevant baseline characteristics are presented and substantially
    equivalent among treatment groups or there is appropriate
    statistical adjustment for differences.

**Class II**: Prospective matched group cohort study in a representative
population with masked outcome assessment that meets a--d above OR a RCT
in a representative population that lacks one criterion a--d.

**Class III**: All other controlled trials (including well-defined
natural history controls or patients serving as own controls) in a
representative population, where outcome assessment is independent of
patient treatment.

**Class IV**: Evidence from uncontrolled studies, case series, case
reports, or expert opinion.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each
recommendation (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   This assessment provides the clinician with evidence-based data on
    the efficacy, safety, and mode of use of these new antiepileptic
    drugs (AEDs), which can facilitate the choice of the appropriate
    drugs in the management of children and adults with newly diagnosed
    partial seizure disorders and primary generalized epilepsy.

-   The newer agents are involved in many fewer drugs interactions. Many
    of the newer agents have little, if any, effect on the cytochrome
    P450 (CYP450) enzyme system and other metabolic pathways.

#### POTENTIAL HARMS

**Table: Serious and Nonserious Adverse Events Associated with the New
Antiepileptic Drugs (AEDs)**

-   *Gabapentin*

    -   [Serious adverse events]{.underline}: none

    -   [Nonserious adverse events]{.underline}: weight gain, peripheral
        edema, behavioral changes\*

-   *Lamotrigine*

    -   [Serious adverse events]{.underline}: rash, including Stevens
        Johnson and toxic epidermal necrolysis (increased risk for
        children, also more common with concomitant valproate use and
        reduced with slow titration); hypersensitivity reactions,
        including risk of hepatic and renal failure, disseminated
        intravascular coagulation (DIC), and arthritis

    -   [Nonserious adverse events]{.underline}: tics\* and insomnia

-   *Levetiracetam*

    -   [Serious adverse events]{.underline}: none

    -   [Nonserious adverse events]{.underline}: irritability/behavior
        change

-   *Oxcarbazepine*

    -   [Serious adverse events]{.underline}: hyponatremia (more common
        in elderly), rash

    -   [Nonserious adverse events]{.underline}: none

-   *Tiagabine*

    -   [Serious adverse events]{.underline}: stupor or spike wave
        stupor

    -   [Nonserious adverse events]{.underline}: weakness

-   *Topiramate*

    -   [Serious adverse events]{.underline}: nephrolithiasis, open
        angle glaucoma, hypohidrosis\*

    -   [Nonserious adverse events]{.underline}: metabolic acidosis,
        weight loss, language dysfunction

-   *Zonisamide*

    -   [Serious adverse events]{.underline}: rash, renal calculi,
        hypohidrosis\*

    -   [Nonserious adverse events]{.underline}: irritability,
        photosensitivity, weight loss

\* Predominantly children

**Note**: This is not meant to be a comprehensive list but represents
the most common adverse events, based on consensus of panel. Psychosis
and depression are associated with epilepsy and occur in open label
studies with all new AEDs. Although these side effects may appear more
commonly with some drugs than with others, it is difficult to ascertain
whether these relationships are causal. Consequently, these side effects
have been omitted from the table.

-   Common drug-drug interactions associated with new AEDs are listed in
    Table 2 of the original guideline document.

-   The effects of comorbid conditions or their treatment on the adverse
    effects or pharmacokinetics of AEDs are listed in Table 4 of the
    original guideline document.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   The guideline subcommittee recognizes that these are antiseizure and
    not antiepileptic drugs (AEDs). Nevertheless, they have decided to
    use in this assessment the term AEDs, given its widespread use.

-   This statement is provided as an educational service of the American
    Academy of Neurology (AAN). It is based on an assessment of current
    scientific and clinical information. It is not intended to include
    all possible proper methods of care for a particular neurologic
    problem or all legitimate criteria for choosing to use a specific
    procedure. Neither is it intended to exclude any reasonable
    alternative methodologies. The AAN recognizes that specific patient
    care decisions are the prerogative of the patient and the physician
    caring for the patient, based on all of the circumstances involved.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Patient Resources\
Personal Digital Assistant (PDA) Downloads\
Quick Reference Guides/Physician Guides\
Slide Presentation

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

French JA, Kanner AM, Bautista J, Abou-Khalil B, Browne T, Harden CL,
Theodore WH, Bazil C, Stern J, Schachter SC, Bergen D, Hirtz D,
Montouris GD, Nespeca M, Gidal B, Marks WJ Jr, Turk WR, Fischer JH,
Bourgeois B, et al. Efficacy and tolerability of the new antiepileptic
drugs I: treatment of new onset epilepsy: report of the Therapeutics and
Technology Assessment Subcommittee and Quality Standards Subcommittee of
the American Academy of Neurology and the AES. Neurology 2004 Apr
27;62(8):1252-60. \[21 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15111659)

#### ADAPTATION

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

#### DATE RELEASED

2004 Apr 27

#### GUIDELINE DEVELOPER(S)

American Academy of Neurology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

American Academy of Neurology (AAN)

#### GUIDELINE COMMITTEE

Therapeutics and Technology Assessment Subcommittee of the American
Academy of Neurology

Quality Standards Subcommittee of the American Academy of Neurology

American Epilepsy Society Guidelines Task Force

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*American Academy of Neurology (AAN) Therapeutics and Technology
Assessment Subcommittee Members*: Douglas Goodin, MD (*chair*); Yuen So,
MD, PhD (*vice-chair*); Carmel Armon, MD, MHS; Richard Dubinsky, MD;
Mark Hallett, MD; David Hammond, MD; Chung Hsu, MD, PhD; Andres Kanner,
MD; David Lefkowitz, MD; Janis Miyasaki, MD; Michael Sloan, MD; James
Stevens, MD

*AAN Quality Standards Subcommittee Members*: Gary Franklin, MD, MPH
(*co-chair*); Gary Gronseth, MD (*co-chair*); Charles Argoff, MD;
Christopher Bever, Jr., MD; Jody Corey-Bloom, MD, PhD; John England, MD;
Gary Friday, MD; Michael Glantz, MD; Deborah Hirtz, MD; Donald Iverson,
MD; David Thurman, MD; Samuel Wiebe, MD; William Weiner, MD; Stephen
Ashwal, MD; Jacqueline French, MD; Catherine Zahn, MD

*AES Guidelines Task Force Members*: Jacqueline French, MD; Andres
Kanner, MD; Mimi Callanan, RN; Jim Cloyd, PhD; Pete Engel, MD, PhD; Ilo
Leppik, MD; Martha Morrell, MD; Shlomo Shinnar, MD, PhD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Members \[of the panel\] did not review a given antiepileptic drug (AED)
if they had served as advisors for the pharmaceutical company that
manufactured the drug or if they had been awarded a research grant from
that company (participation in multicenter studies was not a reason for
exclusion) or if they had financial interests in that company (stock
ownership or employee).

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: A list of American Academy of Neurology (AAN)
guidelines, along with a link to a Portable Document Format (PDF) file
for this guideline, is available at the [AAN Web
site](http://aan.com/go/practice/guidelines).

Print copies: Available from the AAN Member Services Center, (800)
879-1960, or from AAN, 1080 Montreal Avenue, St. Paul, MN 55116.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Efficacy and tolerability of the new antiepileptic drugs, I:
    treatment of new onset epilepsy. AAN guideline summary for
    clinicians. St. Paul (MN): American Academy of Neurology. 2. p.
    Available in Portable Document Format (PDF) from the [American
    Academy of Neurology (AAN) Web
    site](http://aan.com/professionals/practice/pdfs/clinician_ep_onset_e.pdf).

-   Practice parameter: efficacy and tolerability of the new
    antiepileptic drugs I: treatment of new onset epilepsy. St. Paul
    (MN): American Academy of Neurology. 2004. 14 p. Available for
    personal digital assistant (PDA) download from the [AAN Web
    site](http://www.aan.com/professionals/practice/guidelines/pda/Antiepileptic_epilepsy.pdf).

-   Slide presentation: efficacy and tolerability of the new
    antiepileptic drugs I: treatment of new onset epilepsy. St. Paul
    (MN): American Academy of Neurology. 2004. Available in Power Point
    from the [AAN Web
    site](http://aan.com/professionals/practice/guidelines/pwr_pnt/New_AEDs_New_onset.ppt).

-   AAN guideline development process \[online\]. St. Paul (MN):
    American Academy of Neurology (AAN). Available from the [AAN Web
    site](http://www.aan.com/go/practice/guidelines/development).

-   Edlund W, Gronseth G, So Y, Franklin G. Clinical practice guideline
    process manual. St. Paul (MN): American Academy of Neurology
    (AAN); 2004. 49 p. Electronic copies available in Portable Document
    Format (PDF) from the [AAN Web
    site](http://www.aan.com/globals/axon/assets/2535.pdf).

#### PATIENT RESOURCES

The following is available:

Efficacy and tolerability of the new antiepileptic drugs, I: treatment
of new onset epilepsy. AAN guideline summary for patients and their
families. St. Paul (MN): American Academy of Neurology (AAN). 2 p.

Electronic copies: Available in Portable Document Format (PDF) from the
[AAN Web
site](http://aan.com/professionals/practice/pdfs/patient_ep_onset_c.pdf).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI on August 17, 2004. The
information was verified by the guideline developer on September 9,
2004. This summary was updated by ECRI on April 21, 2005 following the
release of a public health advisory from the U.S. Food and Drug
Administration (FDA) regarding Trileptal (oxcarbazepine). This summary
was updated by ECRI on November 15, 2006, following the FDA advisory on
Lamictal (lamotrigine). This summary was updated by ECRI Institute on
January 10, 2008, following the U.S. Food and Drug Administration
advisory on Carbamazepine.

#### COPYRIGHT STATEMENT

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

### DISCLAIMER

#### NGC DISCLAIMER

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<http://www.guideline.gov/about/inclusion.aspx> .

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Readers with questions regarding guideline content are directed to
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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008