Felbamate (Page 6 of 9)

Incidence in Controlled Add-On Clinical Studies in Adults

Table 4 enumerates adverse events that occurred at an incidence of 2% or more among 114 adult patients who received Felbamate adjunctive therapy in add-on controlled trials at dosages up to 3600 mg/day. Reported adverse events were classified using standard WHO-based dictionary terminology.

Many adverse experiences that occurred during adjunctive therapy may be a result of drug interactions. Adverse experiences during adjunctive therapy typically resolved with conversion to monotherapy, or with adjustment of the dosage of other antiepileptic drugs.

Table 4 Adults Treatment-Emergent Adverse Event Incidence in Controlled Add-On Trials

Felbamate(N=114)

Placebo(N=43)

Body System/Event

%

%

Body as a Whole

Fatigue

16.8

7.0

Fever

2.6

4.7

Chest Pain

2.6

0

Central Nervous System

Headache

36.8

9.3

Somnolence

19.3

7.0

Dizziness

18.4

14.0

Insomnia

17.5

7.0

Nervousness

7.0

2.3

Tremor

6.1

2.3

Anxiety

5.3

4.7

Gait Abnormal

5.3

0

Depression

5.3

0

Paraesthesia

3.5

2.3

Ataxia

3.5

0

Mouth Dry

2.6

0

Stupor

2.6

0

Dermatological

Rash

3.5

4.7

Digestive

Nausea

34.2

2.3

Anorexia

19.3

2.3

Vomiting

16.7

4.7

Dyspepsia

12.3

7.0

Constipation

11.4

2.3

Diarrhea

5.3

2.3

Abdominal Pain

5.3

0

SGPT Increased

3.5

0

Musculoskeletal

Myalgia

2.6

0

Respiratory

Upper Respiratory Tract Infection

5.3

7.0

Sinusitis

3.5

0

Pharyngitis

2.6

0

Special Senses

Diplopia

6.1

0

Taste Perversion

6.1

0

Vision Abnormal

5.3

2.3

Children
Incidence in a Controlled Add-On Trial in Children with Lennox-Gastaut Syndrome: Table 5 enumerates adverse events that occurred more than once among 31 pediatric patients who received Felbamate up to 45 mg/kg/day or a maximum of 3600 mg/day. Reported adverse events were classified using standard WHO-based dictionary terminology.

Table 5 Children Treatment-Emergent Adverse Event Incidence in Controlled Add-On Lennox-Gastaut Trials

Felbamate(N=31)

Placebo(N=27)

Body System/Event

%

%

Body as a Whole

Fever

22.6

11.1

Fatigue

9.7

3.7

Weight Decrease

Pain

6.5

6.5

0

0

Central Nervous System

Somnolence

48.4

11.1

Insomnia

16.1

14.8

Nervousness

16.1

18.5

Gait Abnormal

9.7

0

Headache

6.5

18.5

Thinking Abnormal

6.5

3.7

Ataxia

6.5

3.7

Urinary Incontinence

6.5

7.4

Emotional Lability

6.5

0

Miosis

6.5

0

Dermatological

Rash

9.7

7.4

Digestive

Anorexia

54.8

14.8

Vomiting

38.7

14.8

Constipation

12.9

0

Hiccup

9.7

3.7

Nausea

6.5

0

Dyspepsia

6.5

3.7

Hematologic

Purpura

12.9

7.4

Leukopenia

6.5

0

Respiratory

Upper Respiratory Tract Infection

45.2

25.9

Pharyngitis

9.7

3.7

Coughing

6.5

0

Special Senses

Otitis Media

9.7

0

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.