The Minster Practice, Lichfield
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| After the publication of the Million Women Study we received a letter from the manufacturers of Livial® (tibolone) which was confusing as it implied that Livial was not a problem regarding breast cancer. Part of the letter read "Livial has been available since 1988 and more than 5,000,000 women years of exposure to Livial have raised no concerns over an increased risk of breast cancer." Yet the Million Women Study specifically showed such an increase. The Medicines & Healthcare products Regulatory Agency (MHRA) insisted that the company write again with clarification which it did on 15th August 2003. This clarified firstly that the Committee for Safety of Medicines (CSM) had advised that Livial did significantly increase the risk of breast cancer. Secondly that the MHRA "notes that the Million Women Study is a large and well designed study and that this provides more robust evidence than the randomised clinical trial evidence for Livial, which was based on an observation period of no longer than a year for most women involved."
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