Strattera®

Strattera®, a drug used to treat attention deficit/hyperactivity disorder (ADHD) in children, teens, and adults also causes serious liver side effects and jaundice. Strattera® may also cause suicidal thoughts in children and teens.

Strattera® is the first and only non-stimulant medication approved by the Food and Drug Administration (FDA) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults. Strattera® is a norepinephrine reuptake inhibitor, a class of ADHD drugs that works differently from the other ADHD medications available.

Strattera® side effects for children and adolescents include:

• Liver dysfunction or severe liver damage such acute hepatitis
• Jaundice (yellow skin or eyes)
• Dark urine
• Tenderness on the right side of the abdomen
• Suicidal thoughts

Strattera® (atomoxetine) is produced by Eli Lilly and Company. Strattera® was approved by the FDA in late 2002 and has rapidly risen to the ranks of best seller. In 2003, 3.5 million prescriptions were prescribed for Strattera® in the United States. Retail sales exceeded $390 million. In September 2005, the FDA advised Eli Lilly to put a label include a “boxed warning” and additional warning statements that alerts health care providers about the increased risk of suicidal thinking in children and adolescents. On December 17, 2004, FDA issued a new bold label warning for Strattera® to include the potential for severe liver toxicity following reports of two patients who suffered severe liver injury. Both patients recovered. The new Strattera® warning advises of severe liver injury that may progress to liver failure, potentially resulting in death, or the need for a liver transplant in some patients. The labeling also notes that the number of actual cases of severe liver injury is unknown because of under-reporting of post-marketing adverse events. The FDA estimates that as few as 1 in 100 to 1 in 10 serious adverse drug reactions are reported to the agency. If you or a loved one has been affected by Strattera®, please contact us for a free case evaluation and consultation.