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PJ Online homeThe Pharmaceutical Journal
Vol 274 No 7336 p166
12 February 2005

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Pharmacists advised of atomoxetine risk

Potential liver problems associated with the use of atomoxetine (Strattera) have been brought to the attention of pharmacists and doctors by the Committee on Safety of Medicines.

In a letter to health professionals (PDF 20K), the CSM highlights a number of severe cases of hepatic disorders reported through the yellow card scheme and advises that patients and parents of children currently receiving atomoxetine should be made aware of this risk.

They should be advised to look out for symptoms such as pain on the right side of the stomach just below the ribs, unexplained nausea, “flu-like” symptoms, dark urine and jaundice.

Routine monitoring of liver function is not recommended but all suspected hepatic reactions should be investigated and patients with jaundice or laboratory evidence of liver damage should stop treatment.

Atomoxetine, which has been on the market in the UK since July last year, is an effective treatment for attention deficit/hyperactivity disorder.

The risk of hepatic reactions with the drug is rare but the CSM and the Medicines and Healthcare products Regulatory Agency are closely monitoring the safety of the drug.

Details of the safety alert are available on the MHRA website (PDF 10K).

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