Eli Lilly & Company is warning that its ADHD drug, Straterra, may cause suicidal thoughts in children and adolescents.
In a press release dated today, Lilly reported that its Straterra clinical trials database had identified a small but statistically significant increased risk of suicidal thoughts among Straterra-treated children and adolescents. Out of 1357 children, there were five reported cases of suicidal thoughts, versus none in a group of 851 patients taking a placebo.
While there was also one case of a suicide attempt in the 1357 patients, no deaths were reported, and there was no indication of an increased risk of suicidal thinking in the adult population.
The FDA has an ongoing review of psychiatric medicines, and requested the clinical trial data from Lilly. The analysis of the data was based on criteria developed by Columbia University and the FDA last year.
Dr. Alan Brier, chief medical officer at Lilly said “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.”
ADHD affects between three and seven percent of school-age children, and about four percent of adults in the United States. Symptoms include distractibility, impulsivity, and a lack of attention and concentration.
According to a recent Center for Disease Control (CDC) study, ADHD is diagnosed more often in boys, and is diagnosed less often in minority children. A report published by the Consumers Union finds that while stimulant drugs are effective, they are probably being prescribed to many children who do not have the disorder.
Lilly plans to add a boxed warning to the product label and is working with the FDA to finalize the updated information that it will send to healthcare professionals and world wide regulatory agencies.