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Important Safety Information
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Professional Resources>
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| Web Resources The following organizations include medical, consumer, and patient advocacy groups. They offer a wealth of information for both you and your patients. The Web sites below are external to GlaxoSmithKline. GlaxoSmithKline does not possess editorial control over the content of the information provided in these Web sites and therefore does not warrant their accuracy or completeness. American Academy of Neurology (AAN) 1080 Montreal Avenue Saint Paul, MN 55116 800-879-1960 651-695-2791 (Fax) www.aan.com American Association of Neuroscience Nurses (AANN) 4700 W. Lake Avenue Glenview, IL 60025 888-557-2266 (US only) 847-375-6430 (Fax) www.aann.org American Epilepsy Society (AES) 342 North Main Street West Hartford, CT 06117 860-586-7505 860-586-7550 (Fax) www.aesnet.org American Therapeutic Recreation Association (ATRA) 629 North Main St. Hattiesburg, MS 39401 601-450-2872 601-582-3354 (Fax) www.atra-tr.org Child Neurology Society (CNS) 1000 West County Road E, Suite 290 Saint Paul, MN 55126 651-486-9447 651-486-9436 (Fax) www.childneurologysociety.org Citizens United for Research in Epilepsy (CURE) 730 N. Franklin Street, Suite 404 Chicago, IL 60654 800-765-7118 312-255-1809 (Fax) www.CUREepilepsy.org Epilepsy Foundation 8301 Professional Place Landover, MD 20785 800-332-1000 www.epilepsyfoundation.org Family Caregiver Alliance (FCA) 180 Montgomery Street, Suite 1100 San Francisco, CA 94104 800-445-8106 415-434-3508 (Fax) www.caregiver.org Healthfinder (Department of Health and Human Services Web site) PO Box 1133 Washington, DC 20013-1133 www.healthfinder.gov National Association of Epilepsy Centers (NAEC) 5775 Wayzata Boulevard, Suite 200 Minneapolis, MN 55416 888-525-6232 952-525-1560 (Fax) www.naecepilepsy.org National Council on Patient Information and Education (NCPIE) 4915 Saint Elmo Avenue, Suite 505 Bethesda, MD 20814-6082 301-656-8565 301-656-4464 (Fax) www.talkaboutrx.org National Family Caregivers Association (NFCA) 10400 Connecticut Avenue, Suite 500 Kensington, MD 20895-3944 800-896-3650 301-942-2302 (Fax) www.nfcacares.org National Institute of Neurological Disorders and Stroke (NINDS) PO Box 5801 Bethesda, MD 20824 800-352-9424 www.ninds.nih.gov National Organization for Rare Disorders (NORD) 55 Kenosia Avenue PO Box 1968 Danbury, CT 06813-1968 203-744-0100 800-999-6673 (voicemail only) 203-798-2291 (Fax) www.rarediseases.org Seizures & Epilepsy Education (SEE) 2122 Rock Hollar Road Stanley, NC 28164 800-397-3605 www.theseeprogram.com Society for Neuroscience (SFN) 1121 14th Street NW, Suite 1010 Washington, DC 20005 202-962-4000 202-962-4941 (Fax) www.sfn.org Resources for Your Patients offers specialized information from GlaxoSmithKline that can be useful in the treatment and management of epilepsy. For the latest medical updates on epilepsy treatment, visit the Web sites for the American Epilepsy Society, the American Academy of Neurology, and the Child Neurology Society. |
| 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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