The National Health Service has issued important safety guidance concerning tibolone, a medication frequently prescribed to alleviate menopausal symptoms and help prevent osteoporosis. While effective for many, the NHS stresses that individuals falling into one of twelve specific groups must exercise caution and speak to a doctor before starting treatment.
Who Must Seek Medical Advice Before Taking Tibolone?
According to official NHS guidance, tibolone, a form of hormone replacement therapy (HRT), is not suitable for everyone. It is crucial for patients with certain pre-existing conditions or histories to consult their GP to assess potential risks. The primary groups advised to seek professional medical advice include:
- Anyone who has ever had an allergic reaction to tibolone or any other medicine.
- Individuals with a history of breast cancer, those undergoing tests for it, or those deemed high-risk due to family history.
- People with cancers sensitive to oestrogens, such as cancer of the womb lining (endometrium).
- Anyone experiencing unexplained vaginal bleeding.
- Those with untreated excessive thickening of the womb lining (endometrial hyperplasia).
- Individuals with a history of blood clots in a vein (venous thrombosis), like deep vein thrombosis (DVT) or a pulmonary embolism.
- People with blood clotting disorders, such as protein C, protein S, or antithrombin deficiency.
- Anyone who has recently had arterial events caused by blood clots, including a heart attack, stroke, or angina.
- Patients with a history of liver disease where liver function tests have not returned to normal.
- Those diagnosed with the rare inherited condition porphyria.
- People with rare inherited issues like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Women who are pregnant or breastfeeding.
Understanding Tibolone and Its Use
Tibolone works by restoring hormone levels and is specifically licensed for women who are post-menopausal, meaning their last period was over a year ago. An exception is made for women who have had their ovaries surgically removed or are taking gonadorelin analogues; they can start the treatment immediately.
The NHS notes that tibolone functions similarly to combined HRT, which contains both oestrogen and progestogen. However, some studies indicate it may not be as effective at raising oestrogen levels as traditional combined HRT. Beyond managing hot flushes and other menopausal symptoms, it is also prescribed to help prevent bone thinning (osteoporosis) after menopause.
Important Drug Interactions and Side Effects
The NHS warning extends to potential interactions with other substances. Patients must inform their doctor about all other medicines, supplements, and herbal remedies they are taking, as these can affect tibolone's efficacy. Specific medicines of concern include:
- Anticoagulants like warfarin.
- Epilepsy medications such as phenytoin or carbamazepine.
- Tuberculosis treatments like rifampicin.
The health service emphasises that herbal remedies and supplements are not tested in the same rigorous way as prescription medicines, making it impossible to guarantee their safety when combined with tibolone.
Tibolone is a prescription-only tablet, typically taken once daily. Patients should be aware that it can take up to three months for symptoms to improve. Common side effects, which often subside within the first few months, include breast tenderness, vaginal irritation, and stomach pain.
For comprehensive information, individuals are directed to consult the official NHS website or speak directly with their pharmacist or GP.
