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| |  FDA Approves Topamax For Pediatric Epilepsy RARITAN, NJ -- July 26, 1999 -- The United States Food and Drug Administration has approved a new use of Ortho-McNeil Pharmaceutical’s anti-epileptic drug Topamax(R) (topiramate) Tablets as add-on treatment for pediatric patients (ages two to 16) who experience partial onset seizures. Topamax is the first new-generation anti-epileptic drug to be approved for the treatment of partial onset seizures in patients as young as two. Partial onset seizures affect nearly half of the 750,000 patients under the age of 18 who have epilepsy, according to the Epilepsy Foundation. Topamax was first approved by the FDA in 1996 as add-on treatment for adults with partial onset seizures. It is marketed in more than 45 countries and to date, has been used to treat seizures in more than 270,000 patients world-wide. The newer anti-epileptic drugs, developed since 1993, generally are associated with fewer side effects than earlier medications. "Topiramate is a very important treatment, particularly for the many thousands of pediatric patients in the U.S. who have not been able to achieve freedom from seizures with other anti-epileptic drugs," said W. Edwin Dodson, M.D., professor of pediatrics and neurology at Washington University School of Medicine, and an investigator in the Topamax clinical trials. "Uncontrolled partial onset seizures can severely undermine quality of life." Partial onset seizures can cause sensory distortion, uncontrolled movements and, in some cases, an altered, trance-like consciousness. Approximately 25 percent of the 2.3 million people in the U.S. diagnosed with epilepsy have seizures that resist treatment with traditional anti-epileptic drugs, according to a recent report by the Epilepsy Foundation. Physicians may prescribe an add-on medication, such as Topamax, when their patients fail to respond to a single anti-epileptic drug. Roughly 30 percent of epilepsy cases are attributed to severe head injury, brain tumour, infection affecting the brain, or stroke. But in most cases, the cause is unknown. Although the onset of epilepsy can occur at any age, 20 percent of cases develop before age five. Seizures, the hallmark of epilepsy, are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. They are categorised as either generalised, affecting both sides of the brain simultaneously, or partial, affecting just one part of the brain. In a double-blinded, randomised, 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 percent reduction in seizures, compared to 11 percent 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. The safety and effectiveness in patients younger than two have not been established. 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 flexibility. Related Links: Topamax, Ortho-McNeil Pharmaceutical
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