Seizure and abnormal heart rhythm warning on atomoxetine
Warnings on the risk of seizures and abnormal heart rhythm when taking atomoxetine (Strattera; Lilly) have been set out in a Medicines
and Healthcare products Regulatory Agency letter to doctors.
The letter follows a Europe-wide review of the risks and benefits of
atomoxetine. The new advice to prescribers is that seizures are a potential
risk with atomoxetine, that treatment should, therefore, be introduced
with caution in patients with a history of seizure and that discontinuation
should be considered in patients who develop seizures or who experience
more frequent seizures. The letter also states that QT interval prolongation
has been associated with atomoxetine treatment and that atomoxetine should,
therefore, be used with caution in those with congenital or acquired
long QT or a family history of QT prolongation. Strattera’s summary
of product characteristics is being updated to reflect these new warnings,
the MHRA says.
The MHRA is also reminding prescribers that patients should be monitored
for signs of depression, suicidal thoughts or suicidal behaviour and
referred for appropriate treatment if necessary and that atomoxetine
should be discontinued in patients with jaundice or laboratory evidence
of liver injury and should not be restarted. |
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