FDA Approves Lamictal(R)XR(TM); An Extended-Release Once-Daily, New Generation Treatment fo...(amictal XR clearly. Depictions of the La...),Health

Date:6/1/2009

amictal XR clearly. Depictions of the Lamictal XR can be found in the Medication Guide. To avoid the medication error of using the wrong drug or formulation, patients should be strongly advised to visually inspect their tablets to verify that they are Lamictal XR each time they fill their prescription.

Patients should not take Lamictal XR if they have had an allergic reaction to lamotrigine or to any of the inactive ingredients.

Common side effects of Lamictal XR include dizziness, diarrhea, weakness and fatigue, difficulty with coordination or balance, tremor, hot flashes, double vision, nausea, depression, muscle ache, and nervousness. Other common side effects that have been reported with another form of Lamictal include headache, sleepiness, and vomiting. Patients should tell their healthcare provider about any side effect that bothers them or does not go away; patients should tell their healthcare provider if they have any changes in their menstrual pattern, such as breakthrough bleeding, while taking Lamictal XR and birth control pills. These are not all the possible side effects of Lamictal XR.

For full prescribing information for Lamictal XR, including Boxed Warning, please visit www.gsk.com.

Editors' Note: About the Studies

FDA approval of Lamictal XR (lamotrigine) was based on data from the ARMOR study, an international, multi-center, randomized, double-blind, placebo-controlled trial of 236 patients 13 years of age or older with inadequately controlled partial seizures, who were taking a stable regimen of one or two antiepileptic drugs (AEDs) and experienced eight or more partial seizures during the eight-week baseline phase of the study. Patients in the baseline period were experiencing four to six seizures per week prior to being randomized to ei
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SOURCE GlaxoSmithKline Copyright©2009 PR Newswire. All rights reserved

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