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In a warning letter dated July 6, the agency's Division of Drug Marketing, Advertising and Communication lashed Jazz for a patient brochure promoting the drug, which carries a boxed warning about suicidality and serious contraindications, for the treatment of seasonal affective disorder and obsessive-compulsive disorder.
Luvox CR Maker Gets FDA Warning for Missing Risk Info
Seeded on Thu Jul 22, 2010 1:02 PM EDT
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The brochure, said FDA, omits a host of important warning information, and thereby “misleadingly suggests that Luvox CR is safer than has been demonstrated.”
And what could be the motives and purpose of leaving out this info? I wonder--
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