Intended for healthcare professionals

Letters Drug safety reporting

A major rethink is needed on reporting adverse drug reactions

BMJ 2012; 345 doi: (Published 24 September 2012) Cite this as: BMJ 2012;345:e6379
  1. Andrew Herxheimer, clinical pharmacologist1,
  2. Sunita Vohra, professor of paediatrics2,
  3. Jean-Louis Montastruc, professor of pharmacology3,
  4. Ralph Edwards, past president, International Society of Pharmacovigilance4
  1. 1UK Cochrane Centre, London N3 2NL, UK
  2. 2University of Alberta, Edmonton, AB, Canada T5K 0L4
  3. 3CHU de Toulouse, Université Paul Sabatier, 31000 Toulouse, France
  4. 4Uppsala Monitoring Centre, Box 1051, SE-751 40 Uppsala, Sweden
  1. a.herxheimer{at}

We agree that spontaneous reporting systems are important but would like to emphasise that most suspected adverse drug reactions are not reported at all, and many reports have limited information.1

New guidelines are useful, but major problems everywhere, not only in the UK, are that the complex data analysis needed on safety is not open to public review and neither is the …

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