New atomoxetine safety recommendations
The MHRA has published the findings (PDF) of a public assessment report into the effects of atomoxetine (Strattera®) on heart rate and blood pressure.
In January, the Drug Safety Update reminded clinicians of the clinically important increases in heart rate and blood pressure seen in some patients and of the need to screen before starting treatment.
This assessment has concluded that heart rate and blood pressure should be monitored regularly throughout treatment. It is also recommended that atomoxetine is not used in patients with severe cardiovascular or cerebrovascular conditions including:
- severe hypertension
- heart failure
- inherited heart conditions or disease
- heart attack or stroke
- cardiomyopathy
- cerebral aneurysm
Patients are advised to tell their doctor immediately if they develop chest pain, shortness of breath or an irregular or faster-than-normal heart beat.
Action: Clinicians should be aware of these new recommendations. Patients who are prescribed atomoxetine may need to be added to routine recall for assessment of blood pressure and pulse.
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