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Lamictal is an anti-seizure and mood-stabilizing drug that has a “Black Box” warning label about deadly cases of Stevens-Johnson Syndrome (SJS), a rare but severe skin reaction.

Lamictal and Stevens-Johnson Syndrome

Lamictal (lamotrigine) and Lamictal XR are anti-epileptic drugs that are used to prevent seizures and stabilize mood swings. One of the most concerning side effects is Stevens-Johnson Syndrome (SJS), a rare but serious rash that frequently causes severe injuries or death.

SJS and Toxic Epidermal Necrolysis

SJS and Toxic Epidermal Necrolysis (TEN) are the same disease, but TEN covers at least 30% of the skin. One in three cases of TEN are deadly. The risk of death from SJS is about 5-15%. Many patients who survive suffer permanent disfigurement or disabilities like blindness. When SJS is caused by infections rather than medications, it is sometimes called erythema multiforme. TEN is also called Lyell’s syndrome, named after the doctor who discovered it.

What is the Risk?

Severe rashes due to SJS, TEN, or severe hypersensitivity reactions were reported during clinical trials for Lamictal in the 1990s. The risk was estimated at 0.8% in patients under 16 years old, and 0.3% in adults. This led the manufacturer to recommend a lower starting dose, which also lowered the risk of SJS from Lamictal to about 0.08% in adults, according to a study published in 2005.

Black Box Warning Label

Lamictal and Lamical XR labels have a Boxed Warning about life-threatening and deadly cases of SJS. Lamictal causes benign rashes in over 5% of patients, but there is no fast way to tell if the rash is actually SJS. Therefore, Lamictal should be discontinued at the first sign of a rash, unless it is clearly not drug-related.

Risk-Factors for SJS

One risk-factor for SJS is administering Lamictal with valproic acid, which is another common anti-seizure medication. The problem is that valproic acid makes it harder for the body to excrete Lamictal. This increases the amount of Lamictal in the blood, and the risk of rashes.

Complications of SJS

SJS causes the top layer of skin (epidermis) to die and peel off. It can also involve mucous membranes in the mouth, nose, eye, genitals, intestines, and lungs. Blisters can continue to develop for up to 2-3 weeks. They can cause permanent scarring, blindness, and severe infections. Most deaths are caused by organ failure due to infection.

Symptoms of SJS

  • Flu-like illness
  • Skin rash that spreads quickly
  • Rash is painful, red or purplish, and raised
  • Blisters
  • Nausea and vomiting
  • Fatigue
  • Fever
  • Itchy skin
  • Sore mouth and throat
  • Vision loss or blindness