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

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Guest guest

Posted
Posted

> 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.

>

> Klein

> Office of Special Health Issues

> Food and Drug Administration

>

> Struble

> Division of Antiviral Drug Products

> Food and Drug Administration

>

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Guest guest

Guest guest

Posted
Posted

> 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.

>

> Klein

> Office of Special Health Issues

> Food and Drug Administration

>

> Struble

> Division of Antiviral Drug Products

> Food and Drug Administration

>

Link to comment
Share on other sites
Guest guest

Guest guest

Posted
Posted

> 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.

>

> Klein

> Office of Special Health Issues

> Food and Drug Administration

>

> Struble

> Division of Antiviral Drug Products

> Food and Drug Administration

>

Link to comment
Share on other sites
Guest guest

Guest guest

Posted
Posted

> 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.

>

> Klein

> Office of Special Health Issues

> Food and Drug Administration

>

> Struble

> Division of Antiviral Drug Products

> Food and Drug Administration

>

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