Strattera, the brand name for atomoxetine manufactured by drug company Eli Lilly and Co., is the first non-stimulant treatment for Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHD) approved by the US Food and Drug Administration (FDA).
A norepinephrine reuptake inhibitor, Strattera is said to be safer than stimulant based ADD and ADHD medications. However, a number of alarming and even potentially fatal side effects have been linked to the use of Strattera since its initial FDA approval in 2002.
In addition to common, and usually minor side effects such as nausea, diminished appetite, insomnia, dry mouth, constipation, fatigue, dizziness, and mood swings, recent studies have linked Strattera to much more serious, and potentially deadly side effects including severe liver damage and suicidal thoughts and attempts at suicide.
Reports linking Strattera to potentially irreversible and even fatal liver damage began appearing shortly after the dangerous drug was released on the US market.
As a result of this alarming data, Eli Lilly updated the warnings on the labeling for Strattera in 2004, indicating that a small percentage of patients may suffer serious liver damage from use of the drug, including cases in which a liver transplant is required and cases that prove fatal. The extent of the damage already suffered by Strattera patients is unknown, however, as a result of inconsistent reporting.
Signs of liver damage include, but are not limited to:
- Prutitus—itchy skin
- Jaundice, indicated by a yellowed appearance to the skin and whites of the eyes
- Dark urine
- Tenderness on the upper right side of the abdomen
- Unexplained flu-like symptoms
Patients taking Strattera who experience any of these symptoms should seek medical attention immediately. Patients who have existing liver damage, or who have experienced jaundice in the past, should not take Strattera.
Studies done after Strattera entered the US market also indicate that Strattera use may cause suicidal thoughts and suicide attempts in patients—especially children.
During the manufacturer’s clinical trials, five of the 1,357 childen taking Strattera reported suicidal ideation or thoughts, and one child attempted suicide but ultimately survived. Of the 851 patients who were given the placebo, none reported thoughts of suicide or suicide attempts.
As a result of these alarming trends, the FDA began requiring Eli Lilly to include a black box warning—the strongest type of warning available—on Strattera’s packaging, warning patients and physicians of this risk.
What You Can Do
If you or someone you love has been injured as a result of taking Strattera, it is important that you seek the advice of an experienced pharmaceutical injury attorney as soon as possible. Your rights may be limited under the law if your case is not filed in a timely manner.
Locate a local attorney who has experience in suits against drug companies. He or she will review your case with you and advise you on how best to proceed to get the compensation you and your family need for the damages you’ve suffered.