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Strattera: new warnings in the UK

Posted by ed_uk on February 25, 2006, at 17:22:25

'Seizure and abnormal heart rhythm warning on atomoxetine

Warnings on the risk of seizures and abnormal heart rhythm when taking atomoxetine (Strattera) 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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poster:ed_uk thread:613259
URL: http://www.dr-bob.org/babble/20060219/msgs/613259.html