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Eli Lilly pays record $1.4bn for promoting off-label use of olanzapine

BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b217 (Published 20 January 2009) Cite this as: BMJ 2009;338:b217
  1. Zosia Kmietowicz
  1. 1London

    The drug giant Eli Lilly has agreed to pay $1.4bn (£1bn; €1.1bn) in settlement for the marketing of its antipsychotic drug olanzapine (Zyprexa) for off-label uses. It is the largest individual corporate fine in history.

    The drug, which is licensed for the treatment of schizophrenia and bipolar disorder, was widely promoted by Eli Lilly between September 1999 and November 2003 to treat more common disorders, such as dementia, agitation, aggression, depression, and sleep problems, said the US Department of Justice in a statement.

    The company began its promotion by encouraging doctors who treated people in nursing homes and assisted care facilities to prescribe olanzapine, because one of the drug’s side effects is sedation. It claimed that “this side effect was a therapeutic benefit, not an adverse event.” The sales force used the slogan “5 at 5,” meaning that 5 mg of olanzapine at 5 pm would …

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