Updated PegIntron Label Psychiatric Warning

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Package information for Intron-A conventional interferon and PegIntron pegylated interferon were updated with a warning that people with psychiatric and substance use disorders may experience worse symptoms.

Conventional and pegylated interferon are approved therapies for chronic hepatitis B, hepatitis C, and certain other viral infections. While these medications stimulate the body's natural immune response, they can cause difficult side effects including flu-like symptoms, depression, and anxiety.

The U.S. Food and Drug Administration (FDA) this month approved updated product label information for the Intron-A and PegIntron brands, emphasizing that they may worsen psychiatric disorders in people with pre-existing mental health conditions.

Below is the text of a recent FDA announcement describing the label changes.

FDA Hepatitis Update -- Labeling Change for Intron A
(Interferon alfa-2b) and PegIntron (Peginterferon alfa-2b)

On June 6, 2011, FDA approved a labeling change to 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.

6/14/11

Source
R Klein and K Struble, Food and Drug Administration. Labeling change for Intron A (Interferon alfa-2b) and PegIntron (Peginterferon alfa-2b). FDA Hepatitis Update. June 8, 2011.