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MHRA under pressure to withdraw rosiglitazone



By Lilian Anekwe

The UK drug regulator has come under fire for failing to act on an expert recommendation to withdraw the type 2 diabetes drug rosiglitazone.

A Freedom of Information Act request by the BMJ has uncovered a report from July from the Commission on Human Medicines, an advisory group to the Medicines and Healthcare Products Regulatory Agency, saying the drug’s risks ‘outweigh its benefits and it no longer has a place on the UK market.’

It followed evidence that the drug increased the risk of myocardial infarction and heart failure. But instead the MHRA issued advice prescribers should follow ‘current contraindications and monitoring requirements for rosiglitazone’.

A BMJ editorial has called for the drug to be withdrawn immediately but the MHRA has said it is waiting for an EU decision, expected later this month.

Dr Richard Lehman, a GP and senior research fellow at the University of Oxford, writing in the BMJ, said: ‘If the regulatory bodies do not insist on definite evidence of greater benefit than harm to patients, rather than changes in surrogate end points, they are failing in their basic purpose.’

Professor Nick Fremantle, professor of clinical epidemiology and biostatistics at the University of Birmingham, said: ‘If we are to avoid similar problems in other clinical areas, we need a far more widespread overhaul in the standards of regulatory trials.’

A spokesperson for rosiglitazone manufacturer GSK said: ‘No other diabetes medicine introduced in the last ten years has such an extensive safety database.’

Rosiglitazone is used for the treatment of type 2 diabetes