Europe has given its backing to the continued use of Eli Lilly’s ADHD drug Strattera (atomoxetine) in children following a broad review of its safety and after the US giant updated its labeling to including reports of suicidal behaviour.
The review, headed by the UK’s Medicines and Healthcare products Regulatory Agency, concluded that the overall balance of risks versus benefits with Strattera remained positive.
However, alongside the risk of liver disorders and suicidal thoughts/behaviour, it has added new warnings about the link between Strattera and the risk of both seizures and abnormal heart rhythm.
New guidance is being issued to doctors, and the patient information leaflet will be updated accordingly. Dr June Raine, Director of Medicines post-licensing at the MHRA said, “We have written to health professionals to ensure that they are fully aware of the side effects of Strattera to allow them to make informed prescribing decisions. Children who are doing well on this medication should continue their treatment. If any unusual symptoms occur, medical advice should be sought.”
Strattera is already showing signs of struggling in the marketplace after the warnings were laid in, with full year 2005 figures dropping 17% to $552 million.