The attention deficit hyperactivity disorder (ADHD) medication Strattera (atomoxetine hydrochloride) has an updated safety label that warns that patients with severe cardiac or vascular disorders should not take the medication. The drug can cause increases in blood pressure or heart rate that could be deadly in patients with heart problems, especially those that worsen in the event of accelerated blood pressure or heart rate.
The newly updated warnings and contraindications entry on Strattera’s safety label follow a previous warning from July 2012 in which researchers observed that in adult clinical trials some patients experienced elevated blood pressure and heart rates that could be clinically important in some patients.
Sudden death, stroke and myocardial infarction (heart attack) have been reported in patients using Strattera.
Health care professionals are advised not to use Strattera in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities or other serious cardiac problems, and that consideration should be given to not using the medication in adults with clinically significant cardiac abnormalities. The new label also warns that patients who are beginning treatment for ADHD should be monitored for the appearance of or worsening aggressive behavior or hostility.
Any side effects or adverse events with Strattera should be reported to Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.