ADHD drug linked to suicide ideation in children
Although the risk of suicidal behaviour associated with the drug is documented in the product information, atomoxetine is included in the latest Medicines Safety Update from the regulator following 74 reports of psychiatric disorders associated with its use to July 2013.
In 65 of these cases atomoxetine was the sole suspected medicine.
More than half of the cases (42) were reports of suicidal ideation, many in patients under the age of 18.
The TGA also received two reports of attempted suicide in children and adolescents and one report of completed suicide in a child being treated with atomoxetine.
A pooled analysis of 12 short-term trials of the drug, 11 in ADHD and one in enuresis, found the average risk of suicidal ideation in patients treated with atomoxetine was 0.4% compared to 0% for the placebo.
The TGA encouraged health professionals to consider the risk of suicidality against the benefit of treating ADHD in