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.

Table 7: Incidence (%) Of Adverse Reactions In A Placebo-Controlled, Add-On Study In Patients 12 Years Of Age And Older With Myoclonic Seizures By Body System (Adverse Reactions Occurred In At Least 5% Of Levetiracetam-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

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.

Table 8: Adverse Reactions That Resulted In Discontinuation Or Dose Reduction That Occurred More Frequently in Levetiracetam-Treated Patients In The Placebo-Controlled Study In Patients With Juvenile Myoclonic Epilepsy

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.

Table 9: Incidence (%) Of Adverse Reactions In A Placebo-Controlled, Add-On Study In Patients 4 Years Of Age And Older With PGTC Seizures By MedDRA System Organ Class (Adverse Reactions Occurred In At Least 5% Of Levetiracetam-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

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.

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 © 2021. All Rights Reserved.