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Drug dangers not being investigated

Case reports of adverse drug reactions are not being properly investigated and are rarely incorporated into the BNF, researchers warn.

Their study found 83 per cent of case reports of suspected adverse drug reactions in major medical journals had not been followed up five years later. Of 48 drugs listed in reference sources, details of only 15 suspected reactions were added to the Medicines Compendium and only seven to the BNF.

Study leader Dr Yoon Loke, senior lecturer in clinical pharmacology at the University of East Anglia, said: 'Anecdotes need to be confirmed or refuted, rather than being lost or adopted into medical mythology without additional evaluation.'

Dr Loke also said he was 'concerned' that reports were transmitted into product literature in a 'haphazard manner'. The research, published online by the BMJ, evaluated 63 suspected adverse reactions and found 52 had not been subject to detailed evaluation. Only in three cases did follow-up studies provide controlled data that supported the suspected link.

Dr Loke suggested drug regulators and industry should jointly fund independent research into suspected adverse reactions and a consistent policy on inclusion into references should be drawn up. Adverse media reports about paroxetine are followed by sharp, short-term peaks in voluntary 'yellow card' reporting of suspected adverse drug reactions.

A new study, published in the British Journal of Clinical Pharmacology (February), also found falls in prescribing of SSRIs coincided with regulatory communications.

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