- Jul 16, 2001
- 17,915
- 119
- 106
Text
The US Food and Drug Administration warned Thursday that the drug Strattera, which is used to treat attention-deficit hyperactivity disorder (ADHD), may prompt suicidal thoughts in children.
The agency directed the drug's manufacturer, Eli Lilly & Co., to add a black box warning -- the most serious alert -- to the medication's label. Lilly will also develop a patient medication guide.
The warning followed an analysis of a dozen clinical trials involving Strattera. About five patients reported suicidal "ideation," or thoughts. One participant attempted suicide, the FDA said.
The US Food and Drug Administration warned Thursday that the drug Strattera, which is used to treat attention-deficit hyperactivity disorder (ADHD), may prompt suicidal thoughts in children.
The agency directed the drug's manufacturer, Eli Lilly & Co., to add a black box warning -- the most serious alert -- to the medication's label. Lilly will also develop a patient medication guide.
The warning followed an analysis of a dozen clinical trials involving Strattera. About five patients reported suicidal "ideation," or thoughts. One participant attempted suicide, the FDA said.