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NEWS: Zosia Kmietowicz Eli Lilly pays record $1.4bn for promoting off-label use of olanzapine BMJ 2009; 338: b217 [Full text]

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Need for caution

Santhana K Gunasekaran   (23 January 2009)

Need for caution 23 January 2009
Santhana K Gunasekaran, Specialty Registrar HU10 6ED Send response to journal: Re: Need for caution	Drug companies are always keen to promote their products as it is their business. The trials that report beneficial effects of new drugs that are funded by drug companies need to be interpreted with caution. In this case there are a number of concerns which still need further exploration including the antipsychotics use associated with venous thromboembolism and risk of stroke. Earlier in this journal, Douglas & Smeeth [1] reported on exposure to antipsychotics and risk of stroke. Committee on Safety of Medicines (CSM) advised that antipsychotics olanzapine and risperidone should be avoided for the treatment of behavioural and psychological symptoms in dementia in March 2004. They reported that the use of these drugs was associated with a high incidence of stroke in people with dementia and that there was an increase in all- cause mortality with olanzapine. However, as Franks, 2006 [2] reported that from the outset, many clinicians were making risk-benefit decisions not to withdraw medication. He also reported that these decisions were well documented and involved discussions with patients, where appropriate, and their families and in many cases trials of withdrawing medication had failed. It is often difficult to manage important clinical problems such as dementia, agitation, aggression, depression, and sleep problems. When proven non-pharmacological and pharmocological options are exhausted one may understand the reasons for trying newer drugs. However, it is difficult to justify the promotion of an adverse effect as a therapeutic benefit. 1. Ian J Douglas and Liam Smeeth Exposure to antipsychotics and risk of stroke: self controlled case series study BMJ 2008; 337: a1227 2. Karen L. Franks. Response to guidance on use of olanzapine and risperidone: a community-based study of primary and secondary care Psychiatric Bulletin, 2006; 30: 289-292. Competing interests: None declared