Purpose: We systematically reviewed and analyzed published and unpubli
shed cases of Stevens-Johnson syndrome (SJS), or toxic epidermal necro
lysis (TEN) associated with lamotrigine (LTG) therapy to identify char
acteristics of these reactions. Methods: We performed a MEDLINE search
(January 1985 to April 1998) and citation tracking for published repo
rts. In addition, reports were requested from the Uppsala Monitoring C
entre of the World Health Organization (WHO). Published and WHO cases
of LTG-associated SJS or TEN were included if the causal relationship
was assessed as either possible, probable, or definite. Results: We id
entified a total of 57 cases (43 cases of SJS, 14 cases of TEN), of wh
ich 13 (23%) were published. Cases in the SJS group were significantly
younger than in the TEN group (21 years vs. 31 years). The median tim
e to onset (17 days for SJS and TEN) and the median dosage at onset (5
0 mg vs. 87.5 mg) for SJS and TEN did not differ significantly. Concom
itant use of valproate (VPA) was reported in 74% of the SJS cases and
64% of the TEN cases. In three cases, TEN was the cutaneous manifestat
ion of the antiepileptic drug hypersensitivity syndrome (AHS). Conclus
ions: The main features of severe cutaneous drug reactions, such as do
sage, onset, and concomitant VPA use, do not differ in patients with L
TG-induced SJS or TEN. SJS or TEN may also be the cutaneous manifestat
ions of LTG-induced AHS. Further epidemiologic studies are needed to i
dentify the incidence of severe LTG-induced cutaneous adverse reaction
s and the relative risk compared with other AEDs.