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Professional Resources>
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| Pregnancy Registry The information below is intended for US healthcare professionals only. Pregnancy Exposure Registry for LAMICTAL The international pregnancy registry for LAMICTAL is an observational study being conducted by GlaxoSmithKline, in consultation with the Centers for Disease Control and Prevention (CDC) and other agencies, to track the effects of lamotrigine on pregnancy outcomes when mothers have been exposed to LAMICTAL at any time during pregnancy. To facilitate monitoring fetal outcomes of pregnant women exposed to lamotrigine, physicians are encouraged to register patients before fetal outcome (eg, ultrasound, results of amniocentesis, birth) is known and can obtain information by calling the International Lamotrigine Pregnancy Registry at (800) 336-2176 (toll-free). Patients can enroll themselves in the North American Antiepileptic Drug Pregnancy Registry by calling (888) 233-2334 (toll-free). LAMICTAL has an FDA Pregnancy Category C designation. There are no adequate, well-controlled studies of pregnant women receiving LAMICTAL. LAMICTAL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. For more information on the use of LAMICTAL during pregnancy, please see the Pregnancy section of the complete Prescribing Information for LAMICTAL. Information collection and procedures Information collected at the time of registration in the International Lamotrigine Pregnancy Registry includes maternal data; timing, dose, and duration of the drug exposure; estimated date of delivery; and sufficient contact information to allow for follow-up of the subsequent pregnancy outcome. The International Lamotrigine Pregnancy Registry requires the use of a patient identifier (not patient names) assigned by the registering healthcare provider for the purpose of maintaining confidentiality. Around the patient's estimated date of delivery, a short follow-up form is sent to the registering healthcare provider to report on the pregnancy course and outcome. Healthcare providers are encouraged to notify the registry staff of ongoing pregnancies where exposure to LAMICTAL has already occurred. For more information, please call 800-336-2176. |
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| • | Safety and effectiveness of LAMICTAL 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 |
| Important Safety Information | |
| • | Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of LAMICTAL, some of which have included Stevens-Johnson syndrome |
| — Epilepsy clinical trials: The incidence of these rashes is approximately 0.8% (8/1000) in pediatric patients (age <16 years) receiving LAMICTAL as adjunctive therapy for epilepsy and 0.3% (3/1000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1983 pediatric patients with epilepsy taking adjunctive LAMICTAL, there was 1 rash-related death | |
| — Mood disorders: In clinical trials of bipolar and other mood disorders, the incidence of these rashes was 0.08% (0.8/1000) in adults receiving LAMICTAL as initial monotherapy and 0.13% (1.3/1000) in adult patients receiving LAMICTAL as adjunctive therapy | |
| • | In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate |
| • | Hypersensitivity reactions, some fatal or life-threatening, have occurred in association with the use of LAMICTAL. It is important to note that early manifestations of hypersensitivity (eg, fever, lymphadenopathy) may be present even though a rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately, and LAMICTAL should be discontinued if an alternative etiology cannot be established |
| • | 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 |
| • | To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded |
| • | LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related |
Complete Prescribing Information for LAMICTAL® (lamotrigine) Tablets |
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