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FDA Approves Lamictal®XR™ (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients
Date:4/25/2011

aths were reported during the study. Four percent of patients treated with 300 mg/day and 10 percent treated with 250 mg/day discontinued treatment due to adverse events. The only adverse event leading to withdrawal in more than one patient was rash (n=1 in 300mg/day, n=7 in 250 mg/day group).

Treatment-emergent adverse events were reported by 53 percent and 61 percent of patients in the 300 mg/day and 250 mg/day groups, respectively. The most common adverse events occurring in at least 5 percent of patients in either the 300 mg/day or 250 mg/day treatment group, respectively, were: headache (26 and 28 percent), dizziness (11 and 9 percent), rash (4 and 11 percent), nasopharyngitis (6 and 6 percent), nausea (5 and 5 percent), somnolence (4 and 5 percent) and insomnia (0 and 5 percent).

About LamictalXRLamictal XR Extended-Release Tablets are approved in the U.S. as adjunctive therapy for partial seizures and primary generalized tonic-clonic seizures in patients 13 years and older.  

Safety and effectiveness of Lamictal XR for use in patients less than 13 years of age have not been established.

Important Safety InformationPrescription Lamictal XR Extended-Release Tablets are not for everyone. LamictalXR may cause a serious skin rash that may cause patients to be hospitalized or to stop LamictalXR; it may rarely cause death. There is no way to tell if a mild rash will develop into a more serious reaction. These serious skin reactions are more likely to happen when patients begin taking Lamictal XR, within the first two to eight weeks of treatment. But it can happen in people who have taken Lamictal XR for any period of time. Children between 2 to 16 years of age have a higher chance of getting this serious skin reaction while taking lamotrigine. Lamictal XR is not ap
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SOURCE GlaxoSmithKline
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