FDA Hepatitis Update - Labeling change for Intron A (Interfero​n alfa-2b) and PegIntron (Peginterf​eron alfa-2b)

On June 6, 2011, FDA approved a labeling change to the the WARNINGS and PRECAUTIONS: Neuropsychiatric Disorders subsection of both the Intron A (Interferon alfa-2b) and PegIntron (Peginterferon alfa-2b) labels to state that treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders.

Specifically, PegIntron or Intron A should be used with extreme caution in patients with a history of psychiatric disorders. Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is judged necessary in patients with prior history or existence of psychiatric condition or with history of substance use disorders, treatment requires individualized drug screening strategies and frequent psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration