To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Lamictal For A Difficult-To-Treat Childhood Epilepsy URL: http://www.pslgroup.com/dg/ABBF6.htm Doctor's Guide August 27, 1998
RESEARCH TRIANGLE PARK, NC -- Aug. 27, 1998 -- The United States Food and Drug Administration has approved Glaxo Wellcome Inc.'s Lamictal(R) (lamotrigine) Tablets for the add-on treatment of generalised seizures associated with Lennox-Gastaut syndrome (LGS). This syndrome is one of the most severe and difficult-to-control forms of epilepsy in children and adults. Lamictal has been available in the U.S. since 1994 as add-on therapy (prescribed in combination with other antiepileptic medications) for the treatment of partial seizures in adults with epilepsy and has been used by more than 1.38 million patients world-wide. "Studies show that the addition of Lamictal significantly reduces seizures in patients with LGS," said Edwin Trevathan, MD, MPH, Pediatric Epilepsy Center, Washington University School of Medicine, St. Louis, MO., who participated in the clinical trials. "This represents a major therapeutic advance because so few medications have proven to be safe and effective for patients with this type of epilepsy." The approval is based on a double blind, placebo-controlled study, published in the New England Journal of Medicine, that included 169 patients in 43 study sites. In that study, Lamictal or placebo was added to the patients' current antiepileptic drug regimen. Results show that patients treated with Lamictal as add-on therapy experienced significant reduction in the frequency of all major seizure types compared with patients receiving placebo (32 percent versus nine percent). Drop attacks were significantly reduced by Lamcital (34 percent) compared to placebo (nine percent), as were tonic-clonic seizures (36 percent reduction for Lamictal versus 10 percent increase for placebo). LGS is characterised by frequent seizures of several types, some of which cause falls and subsequent injuries. LGS patients often exhibit impaired intellectual function and developmental delay. The catastrophic condition usually develops between the ages of one and eight years and affects between three and 11 percent of children with epilepsy. Because the seizures often are difficult to treat, most LGS patients maintain a treatment regimen that includes more than one type of antiepileptic drug. However, complete seizure control is rarely achieved. Many LGS patients have dose-related drug toxicity, as high doses of antiepileptic drugs are combined in an attempt to control seizures. Frequent changes in dose and type of medication are often necessary. The most frequent adverse events reported in the study were pharyngitis (sore throat) (14 percent) versus placebo (10 percent) and infections (13 percent) versus placebo (eight percent). Rash was reported by seven patients treated with Lamictal versus six patients on placebo. Rash in two patients treated with Lamictal was serious, but resolved without after effect. The most commonly reported adverse experiences that led to discontinuation were rash for patients treated with Lamictal and deterioration of seizure control for patients treated with placebo. A new chewable, dispersible form of Lamictal is available in 5 mg and 25 mg tablets. The new tablets can be chewed, swallowed whole or dissolved in liquid for administration by bottle or spoon for children, or for patients who have difficulty with administration, such as adults with disabilities and/or the elderly. The lowest available strength of Lamictal Chewable Dispersible Tablets is 5 mg and only whole tablets should be administered. Additionally, since the dosing of Lamictal in pediatric patients is based on body weight, certain low-weight pediatric patients should not receive Lamictal because therapy cannot be initiated using dosing guidelines and the currently available tablet strengths. Lamictal will also remain available in its original tablet form for oral administration at 25 mg, 100 mg, 150 mg and 200 mg. Safety and effectiveness in patients below the age of 16 other than those with Lennox-Gastaut syndrome have not yet been established. Lamictal is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Serious rashes requiring hospitalisation and discontinuation of treatment have been reported in association with the use of Lamictal. The incidence of these rashes, which have included Stevens-Johnson Syndrome is approximately one percent in pediatric patients (age <16 years) and 0.3 percent in adults. In world-wide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported, but their numbers are too few to permit a precise estimate of the rate. Lamictal should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. 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