|Manufacturer:||MUTUAL PHARMACEUTICAL COMPANY, INC.|
|Other Info:||Maalox® is a registered trademark of Novartis Consumer Health, Inc.Manufactured By:MUTUAL PHARMACEUTICAL COMPANY, INC.Philadelphia, PA 19124 USARev: May 2006S|
Gabapentin use in pediatric patients with epilepsy 3-12 years of age is associated with the occurrence of central nervous system related adverse events.
The most significant of these can be classified into the following categories: 1) emotional lability (primarily behavioral problems), 2) hostility, including aggressive behaviors, 3) thought disorder, including concentration problems and change in school performance, and 4) hyperkinesia (primarily restlessness and hyperactivity).
Among the gabapentin-treated patients, most of the events were mild to moderate in intensity.In controlled trials in pediatric patients 3-12 years of age, the incidence of these adverse events was: emotional lability 6% (gabapentin-treated patients) vs 1.3% (placebo-treated patients); hostility 5.2% vs 1.3%; hyperkinesia 4.7% vs 2.9%; and thought disorder 1.7% vs 0%.
One of these events, a report of hostility, was considered serious.
Discontinuation of gabapentin treatment occurred in 1.3% of patients reporting emotional lability and hyperkinesia and 0.9% of gabapentin-treated patients reporting hostility and thought disorder.One placebo-treated patient (0.4%) withdrew due to emotional lability.