Levetiracetam (Page 6 of 14)

Pediatric Patients 1 Month to < 4 Years

In the 7-day, controlled pediatric clinical study in children 1 month to less than 4 years of age with partial-onset seizures, the most common adverse reactions in patients receiving levetiracetam tablets in combination with other AEDs, for events with rates greater than placebo, were somnolence and irritability. Because of the shorter exposure period, incidences of adverse reactions are expected to be lower than in other pediatric studies in older patients. Therefore, other controlled pediatric data, presented above, should also be considered to apply to this age group.

Table 6 lists adverse reactions that occurred in at least 5% of pediatric epilepsy patients (ages 1 month to < 4 years) treated with levetiracetam tablets in the placebo-controlled study and were numerically more common than in patients treated with placebo. In this study, either levetiracetam tablets or placebo was added to concurrent AED therapy.

Table 6: Adverse Reactions in a Placebo-Controlled, Adjunctive Study in Pediatric Patients Ages 1 Month to < 4 Years Experiencing Partial-Onset Seizures

Levetiracetam Tablets(N = 60)%

Placebo(N = 56)%

Somnolence

13

2

Irritability

12

0

In the 7-day controlled pediatric clinical study in patients 1 month to < 4 years of age, 3% of patients receiving levetiracetam tablets and 2% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. There was no adverse reaction that resulted in discontinuation for more than one patient.

Myoclonic Seizures

Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial-onset seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse reaction pattern for patients with JME is expected to be essentially the same as for patients with partial seizures.

In the controlled clinical study in patients 12 years of age and older with myoclonic seizures [see Clinical Studies (14.2)] , the most common adverse reactions in patients receiving levetiracetam tablets in combination with other AEDs, for events with rates greater than placebo, were somnolence, neck pain, and pharyngitis.

Table 7 lists adverse reactions that occurred in at least 5% of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with levetiracetam tablets and were numerically more common than in patients treated with placebo. In this study, either levetiracetam tablets or placebo was added to concurrent AED therapy.

Table 7: Adverse Reactions in a Placebo-Controlled, Adjunctive Study in Patients 12 Years of Age and Older with Myoclonic Seizures

Levetiracetam Tablets(N = 60)%

Placebo(N = 60)%

Somnolence

12

2

Neck pain

8

2

Pharyngitis

7

0

Depression

5

2

Influenza

5

2

Vertigo

5

3

In the placebo-controlled study, 8% of patients receiving levetiracetam tablets and 2% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. The adverse reactions that led to discontinuation or dose reduction and that occurred more frequently in levetiracetam tablets-treated patients than in placebo-treated patients are presented in Table 8.

Table 8: Adverse Reactions that Resulted in Discontinuation or Dose Reduction in a Placebo-Controlled Study in Patients with Juvenile Myoclonic Epilepsy

Adverse Reaction

Levetiracetam Tablets(N = 60)%

Placebo(N = 60)%

Anxiety

3

2

Depressed mood

2

0

Depression

2

0

Diplopia

2

0

Hypersomnia

2

0

Insomnia

2

0

Irritability

2

0

Nervousness

2

0

Somnolence

2

0

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