The new labels warn that people with severe heart conditions should avoid taking Strattera because it can cause increases in heart rate and blood pressure.
"Talk to your psychiatrist about any pre-existing conditions."
The FDA reviewed results from clinical trials of ADHD using Strattera.
They found that five to ten percent of both children and adults had an increase in blood pressure and heart rate while taking the medication.
The blood pressure and heart rate changes were significant enough to be clinically important, and the FDA warns these changes could be harmful to people with severe heart conditions.
Blood pressure and heart rate increases were already listed as possible side effects of Strattera. This new labeling warns against taking Strattera if the patient has a heart condition for which a 15 to 20 point blood pressure change or a 20 beat per minute heart rate increase would be harmful.
Strattera is a selective norepinephrine reuptake inhibitor that helps ADHD symptoms by increasing the amounts of the norepinephrine.
Norepinephrine is a neurotransmitter that is important for wakefulness and attention, but it also plays an important role in the control of heart rhythms and function.
Strattera is marketed by Eli Lilly and is FDA approved for the treatment of ADHD in both children and adults.
The new FDA warning was published in June on the FDA safety information pages on its website.