SIDE EFFECTS

Clinical Studies 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.

The prescriber should be aware that the adverse reaction incidence figures in the following table, obtained when KEPPRA XR (levetiracetam extended-release tablets) was added to concurrent AED therapy, cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and non-drug factors to the adverse reaction incidences in the population studied.

KEPPRA XR (levetiracetam extended-release tablets) Tablets

In the well-controlled clinical study using KEPPRA XR (levetiracetam extended-release tablets) in patients with partial onset seizures, the most frequently reported adverse reactions in patients receiving KEPPRA XR (levetiracetam extended-release tablets) in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were irritability and somnolence.

Table 2 lists treatment-emergent adverse reactions that occurred in at least 5% of epilepsy patients treated with KEPPRA XR (levetiracetam extended-release tablets) participating in the placebo-controlled study and were numerically more common than in patients treated with placebo. In this study, either KEPPRA XR (levetiracetam extended-release tablets) or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 2: Incidence (%) Of Treatment-Emergent Adverse Reactions In The Placebo-Controlled, Add-On Study By Body System (Adverse Reactions Occurred In At Least 5% Of KEPPRA XR (levetiracetam extended-release tablets) -Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Discontinuation Or Dose Reduction In The KEPPRA XR (levetiracetam extended-release tablets) Well-Controlled Clinical Study

In the well-controlled clinical study using KEPPRA XR (levetiracetam extended-release tablets) , 5.2% of patients receiving KEPPRA XR (levetiracetam extended-release tablets) and 2.5% receiving placebo discontinued as a result of an adverse event. The adverse reactions that resulted in discontinuation and that occurred more frequently in KEPPRA XR (levetiracetam extended-release tablets) -treated patients than in placebo-treated patients were asthenia, epilepsy, mouth ulceration, rash and respiratory failure. Each of these adverse reactions led to discontinuation in a KEPPRA XR (levetiracetam extended-release tablets) -treated patient and no placebo-treated patients.

Comparison Of Gender, Age And Race

There are insufficient data for KEPPRA XR (levetiracetam extended-release tablets) to support a statement regarding the distribution of adverse experience reports by gender, age and race.

Table 3 lists the adverse reactions seen in the well-controlled studies of immediate-release KEPPRA tablets in adult patients experiencing partial onset seizures. Although the pattern of adverse reactions in the KEPPRA XR (levetiracetam extended-release tablets) study seems somewhat different from that seen in partial onset seizure well-controlled studies for immediate-release KEPPRA tablets, this is possibly due to the much smaller number of patients in this study compared to the immediate-release tablet studies. The adverse reactions for KEPPRA XR (levetiracetam extended-release tablets) are expected to be similar to those seen with immediate-release KEPPRA tablets.

Immediate-Release KEPPRA Tablets

In well-controlled clinical studies of immediate-release KEPPRA tablets as adjunctive therapy to other AEDs in adults with partial onset seizures, the most frequently reported adverse reactions, not seen at an equivalent frequency among placebo-treated patients, were somnolence, asthenia, infection and dizziness.

Table 3 lists treatment-emergent adverse reactions that occurred in at least 1% of adult epilepsy patients treated with immediate-release KEPPRA tablets participating in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either immediate-release KEPPRA tablets or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 3: Incidence (%) Of Treatment-Emergent Adverse Reactions In Placebo-Controlled, Add-On Studies In Adults Experiencing Partial Onset Seizures By Body System (Adverse Reactions Occurred In At Least 1% Of Immediate-Release KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

In addition, the following adverse reactions were seen in other well-controlled studies of immediate-release KEPPRA tablets: balance disorder, disturbance in attention, eczema, hyperkinesia, memory impairment, myalgia, personality disorders, pruritus, and vision blurred.

Postmarketing Experience

In addition to the adverse reactions listed above for immediate-release KEPPRA tablets [see ADVERSE REACTIONS], the following adverse events have been identified during postapproval use of immediate-release KEPPRA tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The listing is alphabetized: abnormal liver function test, hepatic failure, hepatitis, leukopenia, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), suicidal behavior (including completed suicide), thrombocytopenia and weight loss. Alopecia has been reported with immediate-release KEPPRA use; recovery was observed in majority of cases where immediate-release KEPPRA was discontinued.

Read the entire FDA prescribing information for Keppra XR (Levetiracetam Extended-Release Tablets) »