Topamax

[Topiramate]

Approximately 28% of the 1,757 adults with epilepsywho received topiramate at dosages of 200 to 1,600 mg/ day in clinical studies discon-tinued treatment because of adverse events; an individual patient could have reported more than one adverse event. These adverse events were:

psychomotor slowing (4.0%),
difficulty with memory (3.2%),
fatigue (3.2%),
confusion (3.1%),
somnolence (3.2%),
difficulty with con-centration/ attention (2.9%),
anorexia (2.7%),
depression (2.6%),
dizziness (2.5%),
weight decrease (2.5%),
nervousness (2.3%),
ataxia (2.1%),
paresthesia (2.0%).

Approximately 11% of the 310 pediatric patients who received topiramate at dosages up to 30 mg/ kg/ day discontin-ued due to adverse events. Adverse events associated with discontinuing therapy included

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aggravated convulsions (2.3%),
difficulty with concentration/ attention (1.6%),
language problems (1.3%),
personality disorder (1.3%),
somnolence (1.3%).

Incidence in Controlled Clinical Trials Ð Add-On Therapy Ð Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, and Lennox-Gastaut Syndrome

Table 4 lists treatment-emergent adverse events that occurred in at least 1% of adults treated with 200 to 400 mg/ day topiramate in controlled trials that were numerically more common at this dose than in the patients treated with placebo. In general, most patients who experienced adverse events during the first eight weeks of these trials no longer experienced them by their last visit. Table 7 lists treatment-emergent adverse events that occurred in at least 1% of pediatric patients treated with 5 to 9 mg/ kg topiramate in controlled trials that were numerically more common than in patients treated with placebo.

The prescriber should be aware that these data were obtained when TOPAMAX ® was added to concurrent antiepileptic drug therapy and can-not be used to predict the frequency of adverse events 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 data obtained from other clinical investigations involving different treatments, uses, or investigators. Inspection of these frequencies, however, does provide the prescribing physician with a basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the pop-ulation studied.

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