Adverse events in patients with leprosy on treatment with thalidomide.

INTRODUCTION

Thalidomide, used to treat erythema nodosum leprosum (ENL), is associated with severe adverse events (AEs) and is highly teratogenic.

METHODS

A cross-sectional study was conducted on thalidomide-treated patients with ENL. AEs and selected variables were investigated through interviews and assessment of medical records. Odds ratios with 95% confidence intervals were estimated via logistic regression.

RESULTS

Peripheral neuropathy symptoms and deep vein thrombosis (DVT) were the most common AEs reported. Although women of reproductive age used contraceptives, <50% of patients reported using condoms. Polypharmacy was associated with all endpoints, except DVT.

CONCLUSIONS

Pharmacovigilance is crucial to prevent harmful thalidomide-associated AEs.