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Tibolone and potential risk of venous thromboembolism, myocardial infarction, breast cancer and ovarian cancer

25 November 2011

The European Pharmacovigilance Working Party (PhVWP) has looked at new data from various epidemiological studies on the connection between the use of tibolone, which is authorised for the treatment of symptoms of oestrogen deficiency due to menopause and for the prevention of osteoporosis, and the risk of thromboembolism, myocardial infarction, breast cancer and ovarian cancer.

Based on the new data, PhVWP concluded that:

  • The risk of blood clots (VTE) is lower than the risk for users of other hormone replacement therapy (HRT) products. The studies only included a small group of users, and it cannot be excluded that the risk of VTE is somewhat increased, compared to the control group.
  • There is no evidence that tibolone reduces the risk of a heart attack (AMI) in postmenopausal women.
  • The risk ratio (RR) for breast cancer in women taking tibolone is 1.3; for oestrogen-only HRT it is 1.2, and for oestrogen+progestagen HRT it is 1.7.
  • The relative risk for ovarian cancer with use of tibolone is similar to the risk associated with use of other types of HRT.

The summary of product characteristics will soon be updated with the new information.