Why was Strattera (atomoxetine) pulled from the market?

Strattera (Atomoxetine) Has Not Been Pulled From the Market

Strattera (atomoxetine) has not been pulled from the market and remains an FDA-approved medication for ADHD treatment in both children and adults. 1

Current Status and Regulatory Standing

Atomoxetine continues to be approved and available in many countries, including:

• United States
• European countries
• Australia

Unlike some other medications that have been withdrawn (such as fenfluramine and dexfenfluramine which were removed in 1997 due to heart valve issues 1), atomoxetine remains on the market as a treatment option for ADHD.

Mechanism of Action and Classification

Atomoxetine is distinct from other ADHD medications in several important ways:

• It is a selective norepinephrine reuptake inhibitor (not a stimulant) 1
• It increases both noradrenaline and dopamine in the prefrontal cortex 1
• It is not classified as a controlled substance due to its negligible risk of abuse 2, 3
• It can be administered once or twice daily 4

Safety Profile and Warnings

While atomoxetine remains available, it does carry important safety warnings that clinicians should be aware of:

1. Suicidal Ideation Risk: Analysis of twelve placebo-controlled trials showed a greater risk of suicidal ideation in children and adolescents taking atomoxetine, leading to special warnings by regulatory bodies 1

2. Monitoring Requirements: Patients (especially children) should be monitored for:

   • Suicidality
   • Clinical worsening
   • Unusual changes in behavior
   • Particularly during the first few months of treatment or dose changes 1

3. Cardiovascular Effects: Atomoxetine can cause statistically (though not typically clinically) significant increases in heart rate and blood pressure 2

4. Liver Effects: Rare cases of serious liver injury have been reported 2

5. Common Side Effects: Most frequently reported adverse effects include:

   • Nausea and vomiting
   • Fatigue
   • Decreased appetite
   • Abdominal pain
   • Somnolence 1

Clinical Utility

Despite these warnings, atomoxetine remains a valuable treatment option, particularly for:

• Patients at risk for substance abuse 2, 3
• Patients with comorbid anxiety or tics 2
• Those who prefer not to take a controlled substance 3
• Adults with ADHD (it was the first medication specifically approved for adult ADHD) 3

Dosing Considerations

• Initial dose: 0.5 mg/kg/day for children under 70 kg; 40 mg daily for adults and children over 70 kg 4
• Target dose: 1.2 mg/kg/day for children; 80 mg daily for adults 4
• Maximum dose: 1.4 mg/kg/day or 100 mg/day (whichever is lower) 4
• Dose adjustments needed for hepatic impairment (50% reduction for moderate impairment, 75% reduction for severe impairment) 4
• Drug interactions with CYP2D6 inhibitors (like fluoxetine) require dose adjustments 4

In conclusion, atomoxetine (Strattera) has not been withdrawn from the market and continues to be an important non-stimulant option in the pharmacological management of ADHD in both children and adults.