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news.Eli Lilly is to update the product label for its attention-deficit/hyperactivity disorder medication, Strattera, to reflect new found concerns about a link between the drug and suicidal thoughts among children and adolescents.
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In conjunction with a request from the FDA, Lilly submitted to regulatory agencies an analysis of adverse event data from its Strattera clinical trials database that identified a statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents.
The company reports that out of 1357 patients there were five cases of suicidal thoughts with one attempted suicide, compared with no cases of suicidal thoughts in an 851 patient placebo group.
The company also reports that there was no indication of an increased risk of suicidal thinking in the adult population.
As part of the FDA’s continuing focus on patient safety, the agency and its Pediatric Advisory Committee plan to complete an ongoing review of adverse event data for all ADHD medications by early 2006.
“While suicidal thinking was uncommon in patients on the medication during clinical trials, it is important for parents to be aware it can occur, and to discuss any unusual symptoms with a physician,” Dr Alan Breier, vice president and chief medical officer at Lilly.