(2005; 12 pages)
ATOMOXETINE - Labelling to include liver injury warning
USA. The US FDA has issued a Talk Paper advising of changes to the US atomoxetine (Strattera) labelling, following two reports of severe liver injury in patients who had received the agent for several months. Atomoxetine is a selective norepinephrine reuptake inhibitor indicated in the treatment of attention deficit hyperactive disorder (ADHD) in children, adolescents and adults. The atomoxetine labelling is to be updated to include a bolded warning regarding the risk of severe liver injury that could progress to liver failure, requiring liver transplantation or resulting in death, although it is noted that the actual number of cases is unknown. The new warning advises discontinuation of atomoxetine if patients develop jaundice or laboratory evidence of liver injury. Eli Lilly has agreed to issue a 'Dear Healthcare Professional' letter regarding these changes, and will update the atomoxetine patient package insert to include information about the signs and symptoms of liver disorders.
FDA Talk Paper, 17 December 2004. Available on the Internet at www.fda.gov