New Warning for Strattera

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA 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.

Read the MedWatch 2004 safety summary, including a link to the FDA Talk Paper by clicking HERE!