Eli Lilly and Co. on Thursday said it will add strong warnings to its label for Strattera, used to treat attention-deficit/hyperactivity disorder, including the risk of suicidal thoughts among children and adolescents.
Strattera will now carry a "black box" warning, the strongest required by U.S. regulators.
The warning came after the U.S. Food and Drug Administration requested Lilly to submit an analysis of adverse event data from its Strattera clinical trials data base, which identified a small but statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents.
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