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Important Safety Information
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Professional Resources>
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| Clinical Studies of LAMICTAL This is a list of relevant, peer-reviewed journal articles concerning the use of LAMICTAL in adults and children with certain types of epilepsy. Available articles: Biton V, Sackellares JC, Vuong A, Hammer AE, Barrett PS, Messenheimer JA. Double-blind, placebo-controlled study of lamotrigine in primary generalized tonic-clonic seizures. Neurology. 2005;65:1737-1743. Trevathan E, Kerls SP, Hammer AE, Vuong A, Messenheimer JA. LAMICTAL (lamotrigine) as adjunctive therapy among children and adolescents with primary generalized tonic-clonic seizures. Pediatrics. 2006;118:e371-e378. 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. Motte J, Trevathan E, Arvidsson JFV, et al. Lamotrigine for generalized seizures associated with Lennox-Gastaut syndrome. N Engl J Med. 1997;337:1807-1812. Matsuo F, Bergen D, Faught E, et al. Placebo-controlled study of the efficacy and safety of lamotrigine in patients with partial seizures. Neurology. 1993;43:2284-2291. Gilliam F, Vazquez B, Sackellares JC, et al. An active-control trial of lamotrigine monotherapy for partial seizures. Neurology. 1998;51:1018-1025. |
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. |
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| 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:
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| • | 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 |
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Complete Prescribing Information and Medication Guide for LAMICTAL® (lamotrigine) Tablets and LAMICTAL® ODT™ (lamotrigine) Orally Disintegrating Tablets including Boxed Warning |
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