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European drug agency criticises Roche for failing to report adverse reactions and patient deaths

BMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e4344 (Published 26 June 2012) Cite this as: BMJ 2012;344:e4344
  1. Jacqui Wise
  1. 1London

The Swiss company Roche has been criticised for failing to inform the European Medicines Agency of up to 80 000 possible adverse reactions from its drugs, including 15 161 deaths in the United States.

The reports had been collected through a US patient support programme sponsored by Roche but had not been included in the company’s global safety database as required by the European agency’s pharmacovigilance regulations.

The reports related to a range of drugs provided by Genentech, Roche’s US subsidiary. Genentech produces cancer treatments, such as bevacizumab (which it markets as Avastin) and trastuzumab (Herceptin), and ranibizumab (Lucentis) …

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