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Efficacy & Tolerability Overview> Efficacy in Pediatric Patients> Tolerability in Pediatric Patients Efficacy in Adult Patients> Tolerability in Adult Patients>		Tolerability in Pediatric Patients (≥2 Years of Age) Events occurring in ≥10% of patients with the adjunctive treatment of partial seizures1 Two patients taking LAMICTAL for partial seizures required hospitalization for rash; 1 patient on concomitant valproate (VPA) was given an unconfirmed diagnosis of Stevens-Johnson syndrome (SJS). In both cases, all symptoms resolved when LAMICTAL was withdrawn *Includes rash, erythema multiforme, maculopapular rash, urticaria, SJS, and vesiculobullous rash. Most common adverse events in a trial evaluating LAMICTAL as adjunctive treatment of Lennox-Gastaut syndrome (LGS)2† Two patients taking LAMICTAL and concomitant VPA for LGS withdrew from the study due to rash. Of these patients, 1 was hospitalized for rash and the other received an SJS diagnosis. With both patients, the rash occurred in the fifth week of treatment and resolved without sequelae †Events occurring in ≥9% of patients treated with LAMICTAL and numerically more frequently than placebo. Safety and effectiveness of LAMICTAL and LAMICTAL ODT have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. References: 1. Duchowny M, Pellock JM, Graf WD, et al. A placebo-controlled trial of lamotrigine add-on therapy for partial seizures in children. Neurology. 1999;53:1724-1731. 2. Motte J, Trevathan E, Arvidsson JVF, et al. Lamotrigine for generalized seizures associated with the Lennox-Gastaut syndrome. N Engl J Med. 1997;337:1807-1812.		EFFICACY AND TOLERABILITY Learn more about the efficacy and tolerability your adult patients need.
Important Safety Information About LAMICTAL and LAMICTAL ODT • LAMICTAL ODT is another form of LAMICTAL. • Cases of life-threatening serious rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death, have been caused by LAMICTAL. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include: – coadministration with valproate – exceeding recommended initial dose of LAMICTAL – exceeding recommended dose escalation of LAMICTAL • Benign rashes are also caused by LAMICTAL; however, it is not possible to predict which rashes will prove to be serious or life-threatening. LAMICTAL should be discontinued at the first sign of rash, unless the rash is clearly not drug-related (see Boxed Warning in Prescribing Information). • Hypersensitivity reaction may be fatal or life-threatening. Early signs of hypersensitivity (eg, fever, lymphadenopathy) may present without rash; if signs present, patient should be evaluated immediately. LAMICTAL should be discontinued if alternate etiology for hypersensitivity signs is not found. • Prior to initiation of treatment with LAMICTAL, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately. • Acute multiorgan failure has resulted (some cases fatal). • Blood dyscrasias (eg, neutropenia, thrombocytopenia, pancytopenia) may result either with or without an associated hypersensitivity syndrome. • Antiepileptic drugs, including LAMICTAL ODT, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. • Patients treated with any antiepileptic drug for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. • Patients, their caregivers, and families should be informed that antiepileptic drugs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. Medication Guide for LAMICTAL® (lamotrigine) Tablets and LAMICTAL® ODT™ (lamotrigine) Orally Disintegrating Tablets Complete Prescribing Information and Medication Guide for LAMICTAL® (lamotrigine) Tablets and LAMICTAL® ODT™ (lamotrigine) Orally Disintegrating Tablets including Boxed Warning This website is funded and developed by GlaxoSmithKline. This site is intended for US healthcare professionals only. © 1997-2010 GlaxoSmithKline. All Rights Reserved. Legal Notices | Privacy Statement | Medicine Savings | Contact Us