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Important Safety Information About LAMICTAL XR (lamotrigine) Extended-Release Tablets

Serious rashes and hypersensitivity reactions

• Cases of life-threatening serious rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death, have been caused by lamotrigine. 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 XR
  • Exceeding recommended dose escalation of LAMICTAL XR
• Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life-threatening. LAMICTAL XR should be discontinued at the first sign of rash unless the rash is clearly not drug-related.
• Hypersensitivity reaction may be fatal or life-threatening. Early signs of hypersensitivity (e.g., fever, lymphadenopathy) may present without rash; if signs present, patient should be evaluated immediately.
• LAMICTAL XR should be discontinued if alternate etiology for hypersensitivity signs is not found.
• Prior to initiation of treatment with LAMICTAL XR, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.

Suicidal thoughts or behavior

• Antiepileptic drugs, including LAMICTAL XR, 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.

Other warnings

• Acute multiorgan failure has resulted (some cases fatal).
• Blood dyscrasias (e.g., neutropenia, thrombocytopenia, pancytopenia) may result, either with or without an associated hypersensitivity syndrome.

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Reference:

¹US Department of Health and Human Services. Food and Drug Administration. Electronic Orange Book.
http://www.fda.gov/cder/ob/default.htm. Accessed July 30, 2009.

Complete Prescribing Information including Boxed Warning for LAMICTAL XR (lamotrigine) Extended-Release Tablets

Medication Guide for LAMICTAL XR (lamotrigine) Extended-Release Tablets