MHRA: Tibolone (Livial) increases risk of breast cancer recurrence

The Medicines and Healthcare products Regulatory Agency (UK) warned in the February 2009 Drug Safety Advice about the increased breast cancer recurrence in patients treated with tibolone (Livial):

Treatment for breast cancer (e.g., tamoxifen) can commonly exacerbate menopausal symptoms. Although tibolone is contraindicated in women with known or suspected breast cancer, and in those with a history of breast cancer, anecdotal evidence suggests that tibolone is sometimes used off-label for treatment of vasomotor symptoms in women with a history of breast cancer; tibolone may be perceived as being safer than conventional HRT in this respect.

Recently, the LIBERATE randomised controlled trial in women with previous breast cancer was stopped 7 months early because it was unable to establish non-inferiority of tibolone compared with placebo for risk of breast cancer: importantly, it identified a significantly increased risk of breast cancer recurrence.

The advice for health professionals from the MHRA:

Tibolone (or conventional HRT) should not be used in women with known or suspected breast cancer , or in those with a history of breast cancer

See also: The Effects of Tibolone in Older Postmenopausal Women. August 2008, NEJM.

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