By Akanksha,Staff Reporter, [RxPG] Atomoxetine (Strattera), a drug indicated for attention deficit Hyperactivity disorder (ADHD) in adults and children, now carries a warning about the potential for severe liver injury.
The labeling information is being updated with a bolded warning following two reports of patients(a teenager and an adult) who had been treated with atomoxetine for several months, and developed severe liver injury. Both patients recovered from the liver toxicity.
The actual number of liver toxicity cases with atomoxetine is unknown because of under-reporting of post-marketing adverse events. The drug has been on the market since 2002 and has been used in more than 2 million people. In clinical trials of 6000 patients, no signs of liver injury occurred.
The warning describes the possibility that severe liver toxicity may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients.
Atomoxetine should be discontinued in patients who developed jaundice or laboratory evidence of liver injury.
FDA has asked the manufacturer to add a bolded warning about severe liver injury to the labeling. Eli Lilly has agreed to alert health care professionals about the new information in a Dear Health Professional letter. The company will also update the patient package insert with information about the signs and symptoms of liver problems, which include:Pruritus (Itchy skin),Jaundice,Dark urine,upper right-sided abdominal tenderness or unexplained �flu-like� symptoms
