Regulatory Focus™ > News Articles > NICE Draft Guidance Recommends Drugs Not Indicated for Familial Breast Cancer

NICE Draft Guidance Recommends Drugs Not Indicated for Familial Breast Cancer

Posted 16 January 2013 | By Louise Zornoza

The National Institute of Health and Clinical Excellence (NICE), the UK's cost containment agency, has updated a draft guideline on familial breast cancer treatments in which it recommends the use of tamoxifen or raloxifene as preventive treatments despite the fact that neither is approved for that indication by safety regulators.

The draft, released 15 January 2013, recommends that a patient's physician or oncologist should follow the General Medical Council's (GMC) guideline, Good practice in prescribing medicines - guidance for doctors, and obtain informed consent from the patient before prescribing either drug.

The updated guideline also includes a number of new recommendations on issues such as when to offer patients genetic testing and what patient surveillance strategies should and should not be followed.

Breast cancer is the most common cancer in the UK, with around 50,000 women and 400 men diagnosed with the condition each year. The majority cases are sporadic and occur by chance, but people with a family history of cancer have a much higher chance of developing the disease than those who do not, and at a younger age.


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