The UCB has announced today that Keppra has been approved by the FDA as a treatment for babies as young as one month old that are suffering from partial onset seizures.
Keppra was originally approved as an adjunctive treatment for partial onset seizures in epileptic patients aged four and older. According to Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President of UCB, “As a leader in epilepsy, UCB has a responsibility to develop effective medicines that address unmet medical needs. Our continuing development program with Keppra in young children demonstrates our long-term commitment to epilepsy.”
The FDA based its approval on the information that was provided in a Phase III, double-blind, randomized, multi-center, placebo-controlled study that monitored data that highlighted Keppra’s efficacy and tolerability in patients as young as a month old. For this study, researchers collected data from 116 pediatric patients that suffered from refractory partial onset seizures, aged from one month to four years. The results showed that Keppra helped to cause a significant reduction in how often the patients suffered from their partial onset seizures.
The study showed that 43.1 percent of the patients that were treated with Keppra suffered from as a much as a 50 percent less seizures than those patients that were taking a placebo. As for the tolerance of the drug, the patients generally took well to the drug; the most severe side effect reported being somnolence and irritability.
This information could be a very welcome change for epilepsy patients who are looking for alternatives treatments to Topamax. Adults taking Topamax have experienced a wide variety of serious adverse side effects, including birth defects to babies who are exposed to the drugs while the mothers take the drug during pregnancy. Some of those side effects may include oral clefts, cleft palate, PPHN and neural tube defects. If Keppra proves to be as safe for adults as it is for children, women may be able to take the drug in lieu of Topamax during pregnancy.
If your baby was born with birth defects after being exposed to Topamax in-utero, contact the attorneys at Greg Jones today for a free consultation. I am experienced at fighting Topamax lawsuits and may be able to help you recover money for your baby’s injuries.