Gliomas.

GUIDELINE TITLE
Gliomas.

BIBLIOGRAPHIC SOURCE(S)
National Working Group on Neuro-Oncology. Gliomas. Amsterdam, The Netherlands: Association of Comprehensive Cancer Centres (ACCC); 2008 Aug 5. 28 p. [132 references]

GUIDELINE STATUS
This is the current release of the guideline.

** REGULATORY ALERT **
FDA WARNING/REGULATORY ALERT
Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

December 16, 2008 - Antiepileptic drugs: The U.S. Food and Drug Administration (FDA) has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions. FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling change will be applied broadly.

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Gliomas.