Tibolone (Livial) Safety Information Update

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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.</p>
<p>Tibolone is considered as first line treatment for postmenopausal symptoms and as a second line therapy for the prevention of osteoporosis. </p>
<p>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. </p>
<p>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. </p>
<p><strong>Actions that Public and Healthcare professionals should follow:</strong></p>
<ul>
<li>Patients and their families should be aware of possible risks associated with the use of tibolone (Livial).</li>
<li>Healthcare professionals are advised to assist overall risks of stroke associated with tibolone use prior to prescribe it.</li>
<li>Healthcare professionals should refer women who bleed beyond 6 month of treatment, or after stopping treatment, for gynecological investigation to exclude endometrial malignancies.</li>
<li>Routine breast examination is advised for women using tibolone.</li></ul>
<p><strong>Report Adverse Drug Reactions to the Saudi FDA</strong></p>
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<p>The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at </p>