TITLE

Suicidal risk warnings to be added to antiepileptics

PUB. DATE
January 2009
SOURCE
Reactions Weekly;1/10/2009, Issue 1234, p2
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article reports on the announcement of the U. S. Food and Drug Administration (FDA) that it will require manufacturers of antiepileptic drugs to add a warning to the products' prescribing information or labelling that their use increases the risk of suicidal thoughts and behaviours. The requirements to be submitted by manufacturers include a Risk Evaluation and Mitigation Strategy.
ACCESSION #
36118089

 

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