Clinical Therapeutics 2001


Background: Hypersensitivity reactions consist of a variable group of clinical findings and have been described for a wide variety of chemical compounds.

Objective: This review characterizes the clinical profile of hypersensitivity to the nucleoside reverse transcriptase inhibitor abacavir sulfate.

Methods: We performed a retrospective medical review of pooled adverse events data from ∼200,000 patients who received abacavir in clinical trials, through expanded-access programs, or by prescription from 1996 through 2000. Screened cases of hypersensitivity were classified as either definitive or probable. Definitive cases were identified when initial symptoms resolved on interruption of abacavir therapy and returned on reintroduction of abacavir therapy.