Glitazone scrutiny over fracture risks
European regulators are reviewing the safety of the diabetes drug rosiglitazone after a major study suggested it raises women's risk of fractures.
It follows discussions by the UK's pharmacovigilance expert advisory group, which noted increased rates of fractures in the international ADOPT trial.
GP diabetes experts said the results had been unexpected and were in need of scrutiny.
ADOPT found 9.3 per cent of female patients on rosiglitazone developed fractures, compared with 5.1 per cent with metformin and 3.5 per cent with glyburide.
The results are being evaluated by the European Medicines Agency, which will consider whether product information should be amended.
Its initial review suggests patients should not be advised to move to a different drug.
Dr Martin Hadley-Brown, chair of the Primary Care Diabetes Society and a GP in Thetford, Norfolk, said experts had been puzzled by the findings.
'Nobody can quite explain this; it was not expected and I don't think anyone's got a good explanation for it,' he said.
'I certainly think it will be looked into in more depth. We want to know if a drug we use – and which is very effective – has any problems with it.'
GlaxoSmithKline, manufacturer of rosiglitazone, insisted it had reported the fracture risk as soon as it was observed, and pointed out there was no significant increase in fractures in men.