- 现金
- 62111 元
- 精华
- 26
- 帖子
- 30437
- 注册时间
- 2009-10-5
- 最后登录
- 2022-12-28
|
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
|
|