UK drug regulators urge transparency on adverse events

Tougher legislation is needed on disclosure of adverse events by drug manufacturers, say UK drug regulators.

The Medicines and Healthcare products Regulatory Agency (MHRA) wants the European Commission to tighten rules over providing safety information about drugs on the market.

As part of current proposals, the MHRA wants companies to be legally obliged to disclose information on adverse effects even if noted outside of the European Union or when used outside of marketing authorisations.

It also wants clear time scales within which information should be reported, along with sanctions for failing to comply.

The call follows a four-year investigation by the MHRA into handling of information on use of Seroxat (paroxetine) in under-18s by manufacturers GlaxoSmithKline (GSK).

GSK carried out nine clinical trials into the paediatric use of Seroxat between 1994 and 2002. But the MHRA was only notified of the increased risk of suicidal behaviour in children taking the drug, in 2003, when GSK was applying for the drug licence to be extended to under-18s. This suicidal risk became evident after a meta-analysis of the nine trials.

The drug regulators say that GSK should have disclosed this information earlier than it did.

However, government prosecutors saw no realistic prospect of a conviction because legislation at the time was not sufficiently strong or comprehensive to require drug companies to provide safety information on a drug used outside of its licenced recommendations.

GSK has defended its actions. Dr Alastair Benbow, medical director for GSK Europe, said: ‘We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour in patients under 18.'

The MHRA demand is the latest complaint in the push for pharmaceutical companies to be more transparent about clinical trial data. Last month, UK researchers reported that a meta-analysis of unpublished and published trials showed several common SSRI antidepressants were no more effective than placebo.

MHRA proposals

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