Home » Drug Information » FDA Approved Drugs » 1999
Medical Areas: Neurology | Pediatrics/Neonatology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Ortho-McNeil Pharmaceutical
Approval Status: Approved July 1999
Treatment Area: Neurology
A new use for the anti-epileptic drug, Topamax (topiramate) has
been approved by the FDA. This new use is as an add-on treatment
for pediatric patients (ages 2-16) who experience partial onset
seizures. This is the first anti-epileptic drug to be approved for
treatment of partial onset seizures in patients as young as two.
Partial onset seizures can cause sensory distortion, uncontrolled
movements and, in some cases, an altered, trance-like
Topamax is available as a tablet and in a capsule formulation
that can be opened and sprinkled onto food for easy swallowing. The
capsule also can be swallowed whole, offering patients greater
In a double-blinded, randomized, placebo-controlled trial of 86
pediatric patients between the ages of two and 16, at 17 clinical
sites, Topamax effectively reduced the frequency of partial onset
seizures in this population. Pediatric patients who received
Topamax as add-on therapy with baseline anti-epileptic drugs (AEDs)
over the course of the 16-week trial experienced a 33% reduction in
seizures, compared to 11% for placebo and baseline AEDs.
In the pediatric trial, the most common side effects associated
with Topamax as add-on therapy included excessive drowsiness, loss
of appetite, fatigue, nervousness, difficulty with
concentration/attention, weight decrease, aggressive reaction, and
difficulty with memory.