Updated
PegIntron Label Psychiatric Warning
SUMMARY
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.
