Manufacturer: Eli Lilly
Date approved: 2002
Status: Prescription Only
Approved uses: Treatment of Attention Deficit Disorder with Hyperactivity (ADHD)
Off-Label uses: Treatment of depression and anxiety; illegal use to improve concentration, especially in students
• Increased suicidal thoughts and suicide attempts among children and teens
• liver damage
• weight loss
• impaired motor skills
Strattera is a drug approved for the treatment of attention-deficit disorder with hyperactivity (ADHD) and considered by many to be a “safe” non-stimulant alternative to other ADHD drugs. Manufactured by Eli-Lilly, the drug was called into question in 2005, when the FDA forced it to display a stringent “black box warning” about Strattera’s side effects of suicidal ideation. Children and teenagers are especially at risk; parents of a child who is taking Strattera should be on the lookout for mood swings and suicidal intentions. Initially researched for its potential as an antidepressant, Strattera is now an alternative for patients who want a non-amphetamine-based ADHD drug.
Strattera Not Immune From Increased Suicide Risk
It is considered by many to be a “safe” alternative to amphetamine-laced, stimulant attention-deficit disorder with hyperactivity (ADHD) drugs, but Strattera is not immune to one of ADHD drugs’ most chilling side effects: an increased risk of suicide in children and teens. Strattera, which is manufactured by Eli Lilly, was the first non-stimulant ADHD drug on the market, and has been approved for use in adults, teenagers and children. It now carries a stringent FDA “black box” warning about its possible suicide side effects.
What is Strattera?
Strattera (generic name: atomoxetine, though the drug is not sold in a generic form in the United States due to patent laws) entered its initial clinical trials as an antidepressant drug, but was changed to treatment of ADHD once anti-depressant benefits were not found. The drug inhibits the uptake of norepinephrine, a hormone that affects brain chemistry and is thought to affect depression; it works by allowing the brain to focus and concentrate for longer periods of time, a significant benefit for patients suffering from low focus and decreased concentration levels due to ADHD.
The drug, which has not been classified as a controlled substance or found to be addictive, was initially hailed as the “safer” alternative to ADHD drugs such as Ritalin and Adderall, though its abusive potential has not yet been fully researched. Unlike its amphetamine cousins, Strattera does not have a tendency to create mania in patients, but it has been linked to restlessness, dizziness, and even hallucination in patients, especially when taken in high doses. It is thought that Strattera exacerbates pre-existing anxieties, such as social phobias and panic attacks; other Strattera side effects include risk for liver damage, sexual dysfunction, and drowsiness, especially in adult patients.
Suicidal Ideation: A Significant Risk
Despite its reputation as the “safe” ADHD drug, Strattera was linked to child suicidal ideation in a 2005 study. In this study, five cases of suicidal ideation or suicidal plans and one actual suicide attempt were reported among 1,357 patients taking Strattera; by contrast, none of the 851 placebo patients in the trial’s control group experienced suicidal thoughts or suicide attempts. This study coincided with studies indicating higher risk of suicidal ideation and suicide attempts in drugs such as Adderall, Paxil and Concerta. In September 2005, the FDA issued an alert that the drug may cause suicidal thinking in children and teens and ordered that the Strattera label include a “black box warning” indicating its association with suicidal ideation. The FDA recommends that parents monitor children taking Strattera for mood swings, irritability and anxiety, and/or expressions of suicidal thoughts or desires.
If You’ve Been Affected
If you or your child has been affected by the suicidal thoughts and other Strattera side effects described above, contact a medical provider immediately for psychiatric treatment. Then contact an experienced Strattera attorney for information on whether you have a case. Your Strattera lawyer will help you evaluate whether you qualify for damages such as payment for future and current medical expenses, compensation for pain and suffering and lost wages, and other monies and will help you file your Strattera lawsuit and pursue litigation.