German experts cause controversy after calling for atomoxetine to be withdrawn

BMJ 2008; 337 doi: (Published 18 December 2008) Cite this as: BMJ 2008;337:a3055
  1. Ned Stafford
  1. 1Hamburg

    The German subsidiary of Eli Lilly has strongly defended the firm’s drug atomoxetine, which is used to treat children with attention-deficit/hyperactivity disorder, after experts were quoted on a German television news report as urging the drug’s withdrawal from the market

    The German controversy comes shortly after Lilly changed the drug’s warning label in Europe to conform to the label already used in the United States. A spokesperson for the United Kingdom’s Medicines and Healthcare Products Regulatory Agency told the BMJ that changes to the UK label “include the addition of information regarding the risk of onset or exacerbation of serious psychiatric disorders including psychotic reactions, hallucinations, mania, and agitation.”

    The change is not the first major European-wide regulatory action taken on atomoxetine, which has been marketed by Lilly under the brand name Strattera in the US since 2002 and the UK since 2004, the agency spokesperson …

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