September 5, 2007 – The Medicines and Healthcare products Regulatory Agency (MHRA), the British equivalent of the Saudi Food and Drug Authority (SFDA), announced updated safety information regarding the use of Tibolone, a hormone replacement therapy. Tibolone was first marketed in Saudi Arabia in 1998.
Tibolone is considered as first line treatment for postmenopausal symptoms and as a second line therapy for the prevention of osteoporosis.
The latest edition of the MHRA Drug Safety Update Newsletter included a benefit-risk assessment of tibolone. The concern is over an increased risk of stroke in older postmenopausal women, those women more than 60 years of age, using tibolone.
The long term intervention on fractures with tibolone (LIFT) study, a large randomized controlled study, was discontinued prematurely due to a 2.2-fold increased risk of stroke in tibolone users compared to placebo. The LIFT study also reported one case of endometrial hyperplasia (pre-cancerous changes) as well as four cases of endometrial cancer in tibolone users. Furthermore, The Million Women Study identified a 1.5 fold increase in the risk of developing breast cancer in association with the use of tibolone.
Actions that Public and Healthcare professionals should follow:
Patients and their families should be aware of possible risks associated with the use of tibolone (Livial).
Healthcare professionals are advised to assist overall risks of stroke associated with tibolone use prior to prescribe it.
Healthcare professionals should refer women who bleed beyond 6 month of treatment, or after stopping treatment, for gynecological investigation to exclude endometrial malignancies.
Routine breast examination is advised for women using tibolone.
Report Adverse Drug Reactions to the Saudi FDA
The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at