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U.S. Department of Health and Human Services

Safety

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Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, Lamictal Orally Disintegrating Tablets, and Lamictal XR Extended-Release Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

December 2013

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • Nervous System: Aseptic meningitis
  • Blood and Lymphatic: Lymphadenopathy not associated with hypersensitivity disorder

 

 

August 2012

Summary View

WARNINGS AND PRECAUTIONS

Multiorgan Hypersensitivity Reactions and Organ Failure
  • Multiorgan hypersensitivity reactions, also known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have occurred with Lamictal…
 
Aseptic Meningitis
Therapy with lamotrigine increases the risk of developing aseptic meningitis. Because of the potential for serious outcomes of untreated meningitis due to other causes, patients should also be evaluated for other causes of meningitis and treated as appropriate...
 

USE IN SPECIFIC POPULATIONS

Nursing Mothers
  • Lamotrigine is present in milk from lactating women taking Lamictal…
 

MEDICATION GUIDE

What should I tell my healthcare provider before taking Lamictal…
  • are breastfeeding….and may cause side effects in a breastfed baby. If you breastfeed while taking Lamictal…

 

November 2011

Summary View

Medication Guide

What should I tell my healthcare provider before taking Lamictal ?
  • have had aseptic meningitis after taking Lamictal

 

 

August 2011

Summary View

 

WARNINGS AND PRECAUTIONS

Multiorgan Hypersensitivity Reactions and Organ Failure (Revised)
  • Multiorgan hypersensitivity reactions, also known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have occurred with Lamictal. Some have been fatal or life threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression and other organ systems not noted here may be involved.
  • Fatalities associated with acute multiorgan failure and various degrees of hepatic failure have been reported in 2 of 3,796 adult patients and 4 of 2,435 pediatric patients who received Lamictal in epilepsy clinical trials. Rare fatalities from multiorgan failure have also been 292 reported in postmarketing use.
  • Isolated liver failure without rash or involvement of other organs has also been reported with Lamictal..
  • It is important to note that early manifestations of hypersensitivity (e.g., 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. Lamictal XR should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
  • 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.