Levetiracetam (Page 4 of 11)

Pediatric Patients 4 Years to <16 Years

The adverse reaction data presented below was obtained from a pooled analysis of two controlled pediatric clinical studies in children 4 to 16 years of age with partial onset seizures. The adverse reactions most frequently reported with the use of Levetiracetam in combination with other AEDs, for events with rates greater than placebo, were fatigue, aggression, nasal congestion, decreased appetite, and irritability.

Table 5 lists adverse reactions from the pooled pediatric controlled studies (4 to 16 years of age) that occurred in at least 2% of pediatric Levetiracetam-Treated patients and were numerically more common than in pediatric patients treated with placebo. In these studies, either Levetiracetam or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 5: Incidence (%) Of Adverse Reactions In Pooled Placebo-Controlled, Add-On Studies In Pediatric Patients Ages 4 to 16 Years Experiencing Partial Onset Seizures By Body System (Adverse Reactions Occurred In At Least 2% Of Levetiracetam-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction

Levetiracetam (N=165) %

Placebo (N=131) %

Ear and Labyrinth Disorders

Ear Pain

2

1

Eye Disorders

Conjunctivitis

2

0

Gastrointestinal Disorders

Vomiting

15

12

Abdominal Pain Upper

9

8

Diarrhea

6

5

Constipation

3

1

General Disorders and Administration Site Conditions

Fatigue

11

5

Infections and Infestations

Nasopharyngitis

15

12

Influenza

3

1

Gastroenteritis

2

0

Rhinitis

2

0

Injury, Poisoning and Procedural Complications

Head Injury

4

0

Contusion

3

1

Fall

3

2

Joint Sprain

2

1

Metabolism and Nutrition Disorders

Decreased Appetite

8

2

Anorexia

4

3

Musculoskeletal and Connective Tissue Disorders

Arthralgia

2

0

Neck Pain

2

1

Nervous System

Headache

19

15

Somnolence

13

9

Dizziness

7

5

Lethargy

6

2

Sedation

2

1

Psychiatric Disorders

Aggression

10

5

Abnormal Behavior

7

4

Irritability

7

1

Insomnia

5

3

Agitation

4

1

Depression

3

1

Mood Altered

3

1

Affect Lability

2

1

Anxiety

2

1

Confusional State

2

0

Mood Swings

2

1

Respiratory, Thoracic and Mediastinal Disorders

Cough

9

5

Nasal Congestion

9

2

Pharyngolaryngeal Pain

7

4

In the well controlled pooled pediatric clinical studies in patients 4-16 years of age, 7% of patients receiving Levetiracetam and 9% receiving placebo discontinued as a result of an adverse event.

Adverse reaction information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

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