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Change of prescribing advice announcement for Vagifem.

16 April 2009

The vaginal estrogen preparation, Vagifem®, which is an effective treatment for the menopausal symptoms of vaginal atrophy, (vaginal dryness, discomfort and some urinary problems), has been available for some time but was only licensed in the UK to be used for three months. It is well known that for many women, treatment of such symptoms is needed for much longer than three months and for some, may be needed for many years. It is therefore good news to hear that the three month restriction to duration of therapy with Vagifem® has been lifted. This will now allow Vagifem to be prescribed for as long as symptoms persist.

This decision is following a period of consultation with the Medicines Health and Regulatory Agency (MHRA) in the United Kingdom and now ensures consistency in the licensed prescribing of Vagifem® in countries across the European Union. The Summary of Product Characteristics for Vagifem® now advises that treatment should be reviewed at least annually.

This is supported by the BMS Management of the Menopause handbook of 2006 which gives the following advice on treatment of local urogenital symptoms:

"Treatment is needed long term, if not lifelong, as symptoms return on cessation of treatment"1.

It has been well documented that vaginal atrophy is a chronic condition and the new prescribing information for Vagifem® allows the appropriate length of treatment for the symptoms.


Reference. 1. Reese M. and Purdie DW.
Management of the Menopause: The handbook. 4th edition. 2006 London.
Royal Society of Medicine Press Ltd and
British Menopause Society Publications Ltd. p75 Abbreviated Prescribing Information

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