The anti-epileptic drugs Lamictal and Lamictal XR carry prominent warning labels about Stevens-Johnson Syndrome (SJS). This serious skin reaction is rare, but it often causes permanent side effects or death.
Lamictal and Stevens-Johnson Syndrome
Lamictal and Lamictal XR contain lamotrigine, an anti-seizure medication that is also used to stabilize moods. In rare cases it causes Stevens-Johnson Syndrome (SJS), a skin rash that can be deadly.
SJS and Toxic Epidermal Necrolysis
In the 1990s, several patients in clinical trials for Lamictal developed severe skin rashes, including the most severe form of SJS — Toxic Epidermal Necrolysis (TEN). The risk was estimated at 0.8% for kids under 16, and 0.3% for adults. It decreased to 0.08% in adults when the manufacturer lowered the recommended starting dose, according to a study published in 2005.
SJS and Toxic Epidermal Necrolysis (TEN)
SJS and TEN are different names for the same disease. SJS involves 10% of the skin or less, and the risk of death is 5-15%. In comparison, TEN involves over 30% of the skin, and at least one-third of patients die. Many survivors suffer disability, blindness, or disfigurement. Another name for TEN is Lyell’s syndrome. The conditions are also sometimes diagnosed as erythema multiforme.
Lamictal Black Box Warning for SJS
The FDA requires its strongest warning label — the “Black Box” — to warn about life-threatening and deadly cases of SJS from Lamictal. The agency recommends discontinuing Lamictal at the first sign of a rash, unless the rash is clearly not drug-related. While more than 5% of patients on Lamictal develop benign rashes that are not SJS, there is no way to tell the difference in the early stages.
Risk-Factors for SJS
The risk of SJS increases for patients on Lamictal who are also taking valproic acid, another anti-seizure medication. This combination of drugs increases the amount of Lamictal in the bloodstream, which increases the risk of allergic reactions and SJS.
Complications of SJS
SJS often causes permanent complications. The disease starts with flu-like symptoms and a painful rash that spreads very quickly. Blisters develop and the top layer of skin (epidermis) dies and peels off. SJS can also involve the mucous membranes in the eyes, mouth, nose, throat, intestines, genitals, and lungs. The most serious complications include blindness, infections, organ failure, and death.
Symptoms of SJS
- Flu-like illness
- Skin rash that spreads quickly
- Rash is painful, red or purplish, and raised
- Nausea and vomiting
- Itchy skin
- Sore mouth and throat
- Vision loss or blindness