Eli Lilly Updates Strattera Labeling
Source: Eli Lilly “INDIANAPOLIS, September 29, 2005 /PRNewswire-FirstCall/ — Eli Lilly and Company today announced that it will update the product label globally for its attention-deficit/hyperactivity disorder (ADHD) medication, Strattera, to communicate new information regarding uncommon reports of suicidal thoughts among children and adolescents. In conjunction with a request from the U.S. Food and Drug Administration (FDA), Lilly submitted to regulatory agencies an analysis of adverse event data from its Strattera clinical trials database that identified a small but statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents (5 cases out of 1357 patients or 0.4 percent vs. 0 cases out of 851 patients taking placebo). There also was one case of a suicide attempt in a patient taking the medication (out of 1357 patients). There were no suicides among children, adolescents or adults on the medication during any Strattera clinical trials, and 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.”