FDA approved the following additions to all efavirenz containing labels (SUSTIVA, ATRIPLA, SYMFI and SYMFI Lo) to update the WARNINGS and PRECAUTIONS and ADVERSE REACTIONS: Postmarketing Experience sections.
WARNINGS and PRECAUTIONS
Nervous System Symptoms
Late-onset neurotoxicity, including ataxia and encephalopathy (impaired consciousness, confusion, psychomotor slowing, psychosis, delirium), may occur months to years after beginning EFV therapy. Some events of late-onset neurotoxicity have occurred in patients with CYP2B6 genetic polymorphisms which are associated with increased EFV levels despite standard dosing of EFV. Patients presenting with signs and symptoms of serious neurologic adverse experiences should be evaluated promptly to assess the possibility that these events may be related to EFV use, and whether discontinuation is warranted.
Immune Reconstitution Syndrome
autoimmune hepatitis was added to this subsection
ADVERSE REACTIONS, 6.2 Postmarketing Experience
Central and Peripheral Nervous System subsection was updated to add encephalopathy
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Elizabeth Thompson
Division of Antiviral Products
Food and Drug Administration
Michael Stanfield Jr.
Division of Antiviral Products
Food and Drug Administration
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