From Reuters (1/30):
An FDA advisory panel said Novartis' Focalin should carry a warning about a risk of suicidal thoughts in children receiving the attention-deficit/hyperactivity disorder treatment. The agency identified eight cases of the adverse effect in the past six years. FDA staff and advisers also recommended that Focalin's label warn about angioedema and anaphylaxis risk.
http://www.reuters.com/article/2012/01/30/us-fda-adhd-idUSTRE80T1WI20120130
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