Lilly adding black-box warning to ADHD drug StratteraEli Lilly is adding a black-box warning to its attention deficit/hyperactivity disorder (ADHD) drug Strattera to reflect an increased risk of suicidal thinking in pediatric patients, following an FDA directive.
The company also will issue a "dear doctor" letter about the Strattera (atomoxetine) warning and communicate it to physicians through its sales force, Lilly spokeswoman Valerie Tully told MM&M.
The firm could not comment on how long it would take to develop final label language. "That's something we would be working with the FDA on," Tully said.
The FDA issued a public health advisory to physicians, urging them to closely monitor children and adolescents being treated with the drug, especially in the first few months of therapy.
It also suggested Lilly develop a medication guide (MedGuide) for patients and caregivers, to be distributed by pharmacists.