FDA Issues Labeling Changes for Efavirenz

Efavirenz (EFV) labeling has been revised by the FDA in August 2004. Among the most relevant changes that now appear in the revised labeling are: i) pharmacokinetic data on the interaction with atazanavir or voriconazole; ii) adverse psychiatric experiences; iii) efficacy data through 168 weeks of therapy from Study 006; iv) neurological symptoms;v) risk of immune reconstitution reactions; vi) risk of liver toxicity, and vii) lipid abnormalities.