Lamictal (lamotrigine) is marketed by GlaxoSmithKline and is approved to treat epileptic seizures and bipolar I disorder.

Lamictal Background

Lamictal was initially approved by the U.S. Food & Drug Administration (FDA) in 1994.

Lamictal is used in combination with other drugs to treat epileptic seizures in patients 2 years and older. Lamictal can be used alone to treat epileptic seizures in patients 16 and older.

The FDA has also approved Lamictal as a maintenance treatment in adults with bipolar disorder to help delay the occurrence of mood episodes such as depression, mania, or hypomania.

Lamictal XR, an extended release version of the drug, is only approved for use in adults and children who are at least 13 years old.

Stopping Lamictal without first talking to a doctor can lead to uncontrolled seizures, or new or worsening mental health problems.

How Does Lamictal Work?

Lamotrigine, the active ingredient in Lamictal, works by stabilizing electrical activity in the brain. It does this by blocking sodium channels, which are involved in nerve cell firing.  It also reduces the buildup of chemicals that can be toxic to the brain, such as glutamate.

Lamictal was only the second drug ever approved by the FDA to treat bipolar disorder. It’s not entirely clear how Lamictal works in treating bipolar disorder, but it is thought to be related to the reduction of glutamate in the brain.

Lamictal Black Box Warning

The Lamictal label includes a Black Box Warning – the most urgent safety notice possible – regarding a severe or life-threatening skin rash, especially:

  • In children
  • In people who take too high of a starting a dose
  • Those who also take Depakene or Depakote

Lamictal patients should seek  emergency medical attention if they experience:

  • Fever
  • Sore throat
  • Swelling in the face or tongue
  • Burning in the eyes
  • Skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Lamictal and Suicidal Ideation

Lamictal patients may experience suicidal thoughts while using the medication.

Patients should report any new or worsening symptoms to their doctor, such as:

  • Mood or behavior changes
  • Depression
  • Anxiety
  • Agitation
  • Hostility
  • Restlessness
  • Hyperactivity (mentally or physically)
  • Thoughts about suicide or hurting yourself.

FDA Warning for Lamictal and Serious Immune System Reactions

In April 2018, the FDA warned that Lamictal had been associated with a serious immune system reaction – hemophagocytic lymphohistiocytosis (HLH) — which excessively activates the body’s infection-fighting immune system.

HLH can lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly.

HLH typically presents as a persistent fever, usually greater than 101°F.  The disorder can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs.

Other Lamictal Side Effects

Common Lamictal side effects include:

  • Headache, dizziness
  • Blurred or double vision
  • Tremor, loss of coordination
  • Dry mouth
  • Nausea, vomiting, stomach pain, diarrhea;
  • Fever, sore throat, runny nose
  • Drowsiness, tired feeling
  • back pain
  • Insomnia or other sleep problems.

Lamictal patients should seek emergency medical attention if they experience signs of an allergic reaction, including:

  • Hives
  • Fever
  • Swollen glands
  • Painful sores in or around the eyes or mouth
  • Difficulty breathing
  • Swelling of the face, lips, tongue, or throat

Lamictal patients should contact their doctor if they experience any of the following:

  • The first sign of any skin rash, regardless of how mild.
  • Fever, swollen glands, body aches, flu symptoms, headache, neck stiffness, increased sensitivity to light.
  • Easy bruising or bleeding, severe tingling, numbness, pain, muscle weakness.
  • Pain in the upper stomach, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).
  • Chest pain, irregular heart rhythm, feeling short of breath.
  • Confusion, nausea and vomiting, swelling, rapid weight gain, urinating less than usual or not at all.
  • Pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.
  • Increased seizures or worsening of your bipolar disorder.
  1. FDA (2016) “Lamictal: Highlights of Prescribing Information”,020764s030s031lbl.pdf
  2. FDA (2018) “FDA Drug Safety Communication: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)”
Last Modified: April 26, 2018

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