Strattera (atomoxetine) warning about potential for severe liver injury

  1. 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 at:

    http://www.fda.gov/medwatch/SAFETY/2....htm#Strattera
    •  
  2. 3 Comments

  3. by   jncRN
    Thanks for the notice about Strattera...my son has ADHD, and although Strattera isn't currently approved for use in Canada (where we live), my doctor had mentioned it once. He is currently taking Adderall.




    Quote from brian
    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 at:

    http://www.fda.gov/medwatch/SAFETY/2....htm#Strattera
  4. by   kukitty
    Thanks for the info. I currently am on Strattera and Concerta for adult ADHD. I'm going to talk to my doctor at my next visit! It's been pretty scary with all the new drug warnings coming out from the FDA.
  5. by   apri0608
    I am glad to find this article. My Dr just started me on this and I begin taking it on Monday. I just got diagnosed with severe anxiety and adult ADHD. I am going to check into that. THanks for the help.

close