The manufacturer, Eli Lilly, is to change the label for Strattera in Europe to include warnings about onset of “psychotic reactions, hallucinations, mania and agitation”.
The medical regulatory agency has also concluded that reviews suggest a CAUSAL ROLE for Strattera in inducing homicidal behaviours, aggression and hostility.
It took over two years of foot dragging before the medical authorities in Europe finally decided that Eli Lilly should issue warnings about psychotic reactions in the label for Strattera. But now it’s finally done.
If Lilly doesn’t cause more delays, the new warning text reflecting “the risk of the onset or exacerbation of serious psychiatric disorders, including psychotic reactions, hallucinations, mania and agitation” (MHRA March 30, 2008), should be issued in a few weeks.
Aggression and hostility are already listed harmful effects of Strattera.
What is new is a review of 34 cases of homicidal behaviour and 2 cases of homicide in connection with the drug. In the review it is revealed that in 17 of the 34 cases the homicidal behaviour disappeared when Strattera was discontinued. In one case the drug was re-administrated and the thoughts of murdering came back.
The regulatory agency concluded: “The reviews of homicidal behaviours as well of aggression and hostility suggest that a causal relationship between atomoxetine [Strattera] and physical, verbal and written aggressive behaviours, sometimes of a severe nature, is possible.” (MHRA March 30, 2008)
This conclusion has not yet led to any action from the agency – but parents and doctors should absolutely know that this causal relationship has been shown.
Reporter – investigating psychiatry