FDA Notifications

Intron label change approved by FDA

On June 6, 2011, the Food and Drug Administration (FDA) approved a labeling change to the "warnings" and "precautions" for the Neuropsychiatric Disorders subsection of both the interferon alfa-2b (Intron A®) and peginterferon alfa-2b (PegIntron®) 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, peginterferon alfa-2b and interferon alfa-2b 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.