Levetiracetam (Page 5 of 11)
Myoclonic Seizures
Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial 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 well-controlled clinical study that included both adolescent (12 to 16 years of age) and adult patients with myoclonic seizures, the most frequently reported adverse reactions in patients using Levetiracetam 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 and were numerically more common than in patients treated with placebo. In this study, either Levetiracetam or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.
Body System/ Adverse Reaction | Levetiracetam (N=60) % | Placebo (N=60) % |
Ear and labyrinth disorders | ||
Vertigo | 5 | 3 |
Infections and infestations | ||
Pharyngitis | 7 | 0 |
Influenza | 5 | 2 |
Musculoskeletal and connective tissue disorders | ||
Neck pain | 8 | 2 |
Nervous system disorders | ||
Somnolence | 12 | 2 |
Psychiatric disorders | ||
Depression | 5 | 2 |
In the placebo-controlled study, 8% of patients receiving Levetiracetam 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-Treated patients than in placebo-treated patients are presented in Table 8.
Adverse Reaction | Levetiracetam (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 |
Primary Generalized Tonic-Clonic Seizures
Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial 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 PGTC seizures is expected to be essentially the same as for patients with partial seizures.
In the controlled clinical study that included patients 4 years of age and older with primary generalized tonic-clonic (PGTC) seizures, the most frequently reported adverse reaction in patients using Levetiracetam in combination with other AEDs, for events with rates greater than placebo, was nasopharyngitis.
Table 9 lists adverse reactions that occurred in at least 5% of idiopathic generalized epilepsy patients experiencing PGTC seizures treated with Levetiracetam and were numerically more common than in patients treated with placebo. In this study, either Levetiracetam or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.
Body System/ Adverse Reaction | Levetiracetam (N=79) % | Placebo (N=84) % |
Gastrointestinal disorders | ||
Diarrhea | 8 | 7 |
General disorders and administration site conditions | ||
Fatigue | 10 | 8 |
Infections and infestations | ||
Nasopharyngitis | 14 | 5 |
Psychiatric disorders | ||
Irritability | 6 | 2 |
Mood Swings | 5 | 1 |
In the placebo-controlled study, 5% of patients receiving Levetiracetam and 8% receiving placebo either discontinued or had a dose reduction during the treatment period as a result of an adverse reaction.
This study was too small to adequately characterize the adverse reactions that could be expected to result in discontinuation of treatment in this population. It is expected that the adverse reactions that would lead to discontinuation in this population would be similar to those resulting in discontinuation in other epilepsy trials (see tables 4 and 8).
In addition, the following adverse reactions were seen in other well-controlled adult studies of Levetiracetam: balance disorder, disturbance in attention, eczema, memory impairment, myalgia, and vision blurred.
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