Epidemiological study of severe cutaneous adverse drug reactions in a city district of China.

BACKGROUND

An epidemiological study of severe cutaneous adverse drug reactions (SCADRs) in China has not been reported.

AIMS: To estimate the incidence of SCADRs in a city district of China.

METHODS

A retrospective study was performed in Peking University Third Hospital, the only hospital in Haidian district, Beijing with a dermatology ward. The medical records of inpatients with SCADRs from January 1994 to December 2002 were studied.

RESULTS

The prevalence rates for overall SCADRs, Stevens-Johnson syndrome (SJS), exfoliative dermatitis (ED), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) among hospitalized patients were 0.32, 0.15, 0.10, 0.04 and 0.07 per thousand, respectively. The risk of SCADRs from systemic drugs among hospitalized patients was 0.03/1000 (0.02/1000 for SJS, and 0.01/1000 for ED and DRESS). The reported incidence of SCADRs in Haidian district was not less than 1.8 per million person-years. The reported incidence of ED, SJS, TEN and DRESS in Haidian district was not less than 0.6, 0.8, 0.05 and 0.4 per million person-years, respectively. The most common underlying disorders were infection, pain-related diseases and epilepsy. Antibiotics were the most common offending drugs followed by anticonvulsants and traditional Chinese medicines (TCM).

CONCLUSIONS

These results confirm the relatively low incidence of SCADRs in China. Antibiotics, anticonvulsants and TCM are the most common causative drugs.