Strattera (atomoxetine) - Dec 21, 2004
Audience: Neuropsychiatric and other healthcare professionalsFDA notified health care professionals about a new warning for Strattera, a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and children. The labeling is being updated with a bolded warning about the potential for severe liver injury following two reports (a teenager and an adult) in patients who had been treated with Strattera for several months, both of whom recovered. Health care professionals are encouraged to report any unexpected adverse events associated with Strattera to Eli Lilly or to the FDA MedWatch program.
[December 17, 2004 - Talk Paper - FDA]
[February 01, 2005 - Revised Label - FDA]