ADHD drug can cause liver damage, drugs regulator warns

February 7, 2005
by staff reporter

A drug prescribed to children diagnosed with attention deficit hyperactivity disorder can cause liver damage, the drugs regulator has warned.

After examining research and adverse drug reaction reports , the Medicines and Healthcare Products Regulatory Agency announced atomoxetine - brand name Strattera - may "very rarely" be associated with liver disease.

Atomoxetine has been prescribed to children aged six years and older in the UK since July 2004. There are around 10 000 patients in the UK.

The agency said a total of 41 reports of hepatic disorders have been received worldwide, including two cases of severe acute hepatitis.

It said there is no clear pattern in terms of onset time, and the reactions may occur after several months of treatment.

In some cases liver function continues to worsen after the drug has been stopped.

In the UK, 67 reports of suspected adverse drug reactions in association with atomoxetine have been received through the Yellow Card Scheme, including three reports of hepatic disorders.

The MHRA estimates that the frequency of serious liver reactions with atomoxetine may be less than 1 in 50 000 patients.

The MHRA has advised doctors to inform patients and the parents of children currently receiving atomoxetine of the risk and made aware of possible signs and symptoms.

Read for yourself
Medicines and Healthcare Products Regulatory Agency advice on Strattera for healthcare workers

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