Pharmaceutical Business review

UK regulators warn of Strattera liver risks

A letter from Professor G. Duff, chairman of the Committee on Safety of Medicines, advised doctors and patients of the risk of incurring rare, but sometimes severe, liver problems resulting from Strattera (atomoxetine) use.
The risk is estimated to effect less than one in 50,000 patients.

Strattera has been marketed in the UK since July 2004 and has been available in the US since November 2002.

According to the letter, 41 reports of liver disorders have been received worldwide, including two cases of severe acute hepatitis. There is no clear trend in onset time, and reactions may occur after several months of treatment. In some cases liver function has continued to worsen after the drug has been stopped.

In the UK, 67 reports of suspected adverse drug reactions have been reported, including three reports of liver disorders.

The Committee on Safety of Medicines and the MHRA are monitoring closely the safety of Strattera and liver damage risks are currently being investigated.