FDA: Label Change: Interferon alfa-2b,Peginterferon alfa-2b

StephenW

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

StephenW

6月6日，2011年，美国FDA批准的标签更改为的警告和 注意事项：

神经精神疾病

（干扰素α-2b干扰素）和PegIntron（聚乙二醇干扰素α-2b）的标签:
用干扰素治疗状态可能与 患者症状加剧与精神疾病 共同发生的精神和物质使用障碍。

具体来说，PegIntron 或内含一个使用时应格外小心有精神病患者的病史非议。治疗
干扰素可伴有精神病症状加剧疾病患者与共同发生的精神和物质使用 疾病。如果用干扰素治疗是必要的判断 患者的病史或精神状况或存在与物质使用障碍的历史，治疗需要 个体化药物筛选策略和频繁的精神科 症状监测。早期干预重新出现或发展
神经精神症状，药物使用建议。

理查德克莱
办公室特别卫生问题
食品和药物管理局

与Kimberly斯特鲁布尔
司产品抗病毒药物
食品和药物管理局