United States of America - The US Food and Drug Administration (FDA) is advising health care professionals of a new warning for atomoxatine (Strattera®), a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and children. The labelling is being updated with a bolded warning about the potential for severe liver injury following two reports in patients (a teenager and an adult) who had been treated with atomoxatine for several months, both of whom recovered. The labelling warns that severe liver injury may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients. It also notes that the number of actual cases of severe liver injury is unknown because of under-reporting of postmarketing adverse events.
Atomoxatine, a selective norepinephrine reuptake inhibitor, has been on the market since 2002 and has been used in more than 2 million patients. In clinical trials of 6000 patients, no signal for liver problems (hepatotoxicity) had emerged.
Reference: FDA Talk Paper, T04-60 2004 at http://www.fda.gov/medwatch/