Levetiracetam (Page 4 of 14)

5.10 Seizure Control During Pregnancy

Physiological changes may gradually decrease plasma levels of levetiracetam throughout pregnancy. This decrease is more pronounced during the third trimester. It is recommended that patients be monitored carefully during pregnancy. Close monitoring should continue through the postpartum period especially if the dose was changed during pregnancy.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in more details in other sections of labeling:

Behavior Abnormalities and Psychotic Symptoms [see Warnings and Precautions (5.1)]
Suicidal Behavior and Ideation [see Warnings and Precautions (5.2)]
Somnolence and Fatigue [see Warnings and Precautions (5.3)]
Anaphylaxis and Angioedema [see Warnings and Precautions (5.4)]
Serious Dermatological Reactions [see Warnings and Precautions (5.5)]
Coordination Difficulties [see Warnings and Precautions (5.6)]
Hematologic Abnormalities [see Warnings and Precautions (5.8)]
Increase in Blood Pressure [see Warnings and Precautions (5.9)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Partial-Onset Seizures

Adults

In controlled clinical studies in adults with partial-onset seizures [see Clinical Studies (14.1)] , the most common adverse reactions in patients receiving levetiracetam tablets in combination with other AEDs, for events with rates greater than placebo, were somnolence, asthenia, infection, and dizziness. Of the most common adverse reactions in adults experiencing partial-onset seizures, asthenia, somnolence, and dizziness occurred predominantly during the first 4 weeks of treatment with levetiracetam tablets.

Table 3 lists adverse reactions that occurred in at least 1% of adult epilepsy patients receiving levetiracetam tablets in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either levetiracetam tablets or placebo was added to concurrent AED therapy.

Table 3: Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Studies in Adults Experiencing Partial-Onset Seizures

Levetiracetam Tablets(N = 769)%

Placebo(N = 439)%

Asthenia

15

9

Somnolence

15

8

Headache

14

13

Infection

13

8

Dizziness

9

4

Pain

7

6

Pharyngitis

6

4

Depression

4

2

Nervousness

4

2

Rhinitis

4

3

Anorexia

3

2

Ataxia

3

1

Vertigo

3

1

Amnesia

2

1

Anxiety

2

1

Cough Increased

2

1

Diplopia

2

1

Emotional Lability

2

0

Hostility

2

1

Paresthesia

2

1

Sinusitis

2

1

In controlled adult clinical studies, 15% of patients receiving levetiracetam tablets and 12% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. Table 4 lists the most common (> 1%) adverse reactions that resulted in discontinuation or dose reduction and that occurred more frequently in levetiracetam tablets-treated patients than in placebo-treated patients.

Table 4: Adverse Reactions that Resulted in Discontinuation or Dose Reduction in Placebo-Controlled Studies in Adult Patients Experiencing Partial-Onset Seizures

AdverseReaction

Levetiracetam Tablets(N = 769)%

Placebo(N = 439)%

Somnolence

4

2

Dizziness

1

0

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