European HRT safety probe launched

The European Union medicines regulator is to investigate the safety of hormone replacement therapy products following a new study was published showing an increased risk of breast cancer.

The UK-based study of one million women published in the Lancet last month found combination HRT products doubled the risk of developing breast cancer, with Organon Livial (tibolone) also raising the risk by 45%, and oestrogen-only HRT raising it by 30%

The EMEA cannot launch a formal investigation until a member state requests it does so, but the Agency has pressed ahead with analysis of the risks because of the magnitude of concern,

EMEA spokesman Martin Harvey told the BBC: "We felt this was something that the agency couldn't just ignore, even though no-one has formally referred it to us."

"So if our panel think there are grounds for a formal investigation, our recommendation will be a hint to the members that this is needed."