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03/02/2005
Warning issued over hyperactivity treatment
The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a warning, after a drug prescribed for children was linked to possible liver damage.
Strattera – also known as atomoxetine –was launched in the UK last summer and has been used to treat attention deficit hperactivity disorder (ADHD) in children.
The MHRA has now uncovered evidence which suggests that , in extremely rare cases, the drug may be associated with liver reactions.
Over two million people have treated with the drug in the US and around 10,000 in the UK. The risk of devloping a serious liver reaction while using Strattera has been estimated at around one in 50,000.
Professor Gordon Duff, Chairman of the Committee on Safety of Medicines, said that Strattera had been an important drug in the treatment of ADHD in children and urged doctors and parents to take a "balanced approach" to the new evidence. He said: "Parents should not be dissuaded from having their children treated with this medicine, but it is right that they should be aware of possible, but rare, side effects."
Professor Duff said that new advice regarding Strattera would be issued to doctors, along with a question-and-answer sheet for parents and patients, which would help them to be alert to any signs of liver problems in children taking the drug. He said: "We have advised doctors that if they suspect that liver problems are occuring, treatment should be stopped and an alternative treatment initiated."
The Committee on Safety of Medicines as advised that further work should be undertaken to establish what may be causing these side effects in a small minority of patients, in order to help identify those who would be most likely to be affected.
(KMcA/SP)
Strattera – also known as atomoxetine –was launched in the UK last summer and has been used to treat attention deficit hperactivity disorder (ADHD) in children.
The MHRA has now uncovered evidence which suggests that , in extremely rare cases, the drug may be associated with liver reactions.
Over two million people have treated with the drug in the US and around 10,000 in the UK. The risk of devloping a serious liver reaction while using Strattera has been estimated at around one in 50,000.
Professor Gordon Duff, Chairman of the Committee on Safety of Medicines, said that Strattera had been an important drug in the treatment of ADHD in children and urged doctors and parents to take a "balanced approach" to the new evidence. He said: "Parents should not be dissuaded from having their children treated with this medicine, but it is right that they should be aware of possible, but rare, side effects."
Professor Duff said that new advice regarding Strattera would be issued to doctors, along with a question-and-answer sheet for parents and patients, which would help them to be alert to any signs of liver problems in children taking the drug. He said: "We have advised doctors that if they suspect that liver problems are occuring, treatment should be stopped and an alternative treatment initiated."
The Committee on Safety of Medicines as advised that further work should be undertaken to establish what may be causing these side effects in a small minority of patients, in order to help identify those who would be most likely to be affected.
(KMcA/SP)
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