Parents and caregivers of someone who has seizures associated with Lennox-Gastaut syndrome (LGS) are often concerned with the side effects of seizure medications. Every new side effect means another challenge to overcome.
There are risks associated with the use of BANZEL that you should know about. We encourage you to talk to your healthcare provider about these risks.
QT Shortening
Patients with a history of Familial Short QT syndrome should not be treated with BANZEL. Talk to your healthcare provider if you are unsure if this affects your loved one. BANZEL has been shown to reduce the QT interval. Caution should be used when administering BANZEL with other drugs that shorten the QT interval.
Suicidal Behavior and Ideation
All medications to treat seizures, including BANZEL, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you or your loved one experiences new or worsening symptoms of depression, unusual changes in mood or behavior, thoughts or actions about suicide or self-harm, aggression, agitation, anger, anxiety, or irritability.
Adverse Reactions
Use of BANZEL has been associated with side effects such as sleepiness or feeling tired, difficulty with coordination, dizziness, and problems with walking or movement. Alcohol, in combination with BANZEL, may increase or worsen these side effects.
You or your loved one should take BANZEL only as prescribed. Do not stop taking BANZEL without first talking to your healthcare provider. Stopping BANZEL suddenly can cause serious problems.
Status Epilepticus
Estimates of the incidence of treatment-emergent status epilepticus among patients treated with BANZEL are difficult because standard definitions were not employed. In a controlled Lennox-Gastaut syndrome trial, 3 of 74 (4.1 %) BANZEL-treated patients had episodes that could be described as status epilepticus compared with none of the 64 patients in the placebo-treated group. In all controlled trials that included patients with different epilepsies, 11 of 1240 (0.9%) BANZEL-treated patients had episodes that could be described as status epilepticus compared with none of the 635 patients in the placebo-treated group.
Drug Interactions
BANZEL can interact with other medications. Tell your healthcare provider about all the medicines taken by your child, including prescription and non-prescription medicines, vitamins, and herbal supplements to discuss possible side effects.
Multi-organ Hypersensitivity Reactions
Call your healthcare provider if your loved one experiences a rash. This can be a sign of a more serious condition, such as multi-organ hypersensitivity reaction. For more information please see Medication Guide and the Important Safety Information.
In clinical studies of patients with epilepsy who were treated with BANZEL, in addition to their existing medications, commonly experienced side effects included:
Ask your healthcare provider about adding BANZEL to an existing treatment.
To report suspected adverse reactions, contact Eisai Inc. at 1-888-274-2378 or the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.
For additional information about risks associated with BANZEL, read the Medication Guide and the important safety information below and discuss it with your healthcare provider.
Pregnancy and Nursing – Important information for women: BANZEL may make hormonal contraceptives (birth control pills) less effective. Additional nonhormonal forms of birth control are recommended when using BANZEL.
Healthcare providers should be informed if patients are pregnant or planning on becoming pregnant. Also, BANZEL is likely to be passed through breast milk to the baby and could cause serious side effects in the baby. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Patients who are pregnant are encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334 Additional information about the registry can be found at http://www.aedpregnancyregistry.org/.
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