Updated Labeling for Efavirenz-Containing Products Warns of Possible Late-Onset Neurotoxicity

The Food and Drug Administration (FDA) has approved updated labeling for all efavirenz-containing products (Sustiva, Atripla, Symfi, and Symfi Lo) with additions to the Warnings and Precautions and Adverse Reactions: Postmarketing Experience sections.

The Warnings and Precautions section has been updated to address the potential for late-onset neurotoxicity, including ataxia and encephalopathy with efavirenz treatment. Neurotoxicity may occur months to years after starting efavirenz therapy; some of these events have occurred in patients with CYP2B6 genetic polymorphisms. If patients present with signs and symptoms of neurotoxicity, healthcare professionals should evaluate the possibility that these events may be efavirenz-related. 

Additionally, autoimmune hepatitis has been added under the subsection Immune Reconstitution Syndrome. Autoimmune disorders have been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

Regarding safety, encephalopathy has been added to the labeling as an adverse reaction based on postmarketing experience.

Efavirenz, a non-nucleoside reverse transcriptase inhibitor, is indicated for the treatment of HIV-1 infection in adults and children in combination with other antiretroviral agents.

For more information visit fda.gov.