Women who use hormone replacement therapy for menopausal symptoms have an increased risk of breast cancer. The risk is increased even years after stopping therapy. The European Medicines Agency (EMA) has now modified its safety information.
Hot flashes, mood swings, dizziness – the symptoms of menopause are difficult for many women. Hormone replacement therapy (HRT) can alleviate the unpleasant side effects. Women feel better, but the price of it is an increased risk of breast cancer. Numerous large-scale studies like The million women study have shown this. The relevant product information must point out the risk.
Package inserts are supplemented with new safety instructions
The European Medicines Agency EMA makes regular adjustments, which constantly reassess the risk based on the latest studies. For the latest update of the safety information, the EMA used, among other things, an extensive study that was published in August 2019 in the journal Lancet. This study confirms the increased risk of breast cancer in women using hormone replacement therapy. In addition, the results show that if hormone replacement therapy has been used for more than five years, the risk of breast cancer after discontinuation is increased for at least another ten years.
After evaluating all available evidence, the EMA Pharmacovigilance Risk Assessment Committee (PRAC) concludes:
- The higher risk of breast cancer in women who take combined estrogen-progestagens or pure estrogen becomes clear after about three years of use.
- After stopping hormone replacement therapy, the additional risk decreases over time, and the time it takes to return to baseline depends on the duration of previous HRT use.
- The new information suggests that women who use HRT for more than five years may be at risk for ten years or more.
- For tibolone-containing medicinal products, there is no data on the continued risk after stopping treatment, but a similar pattern cannot be excluded.
- The effect on breast cancer risk is unknown for the combination of conjugated estrogens / bazedoxifene (Duavive®).
- With low-dose vaginal estrogen, there is no evidence that women who have not had breast cancer in the past are at increased risk of breast cancer.
The authorities of the federal states now have to change the product information for hormone replacement therapies accordingly.
Lowest dose and duration of use recommended
The EMA Committee emphasizes that women should only use hormone replacement therapy to treat menopause symptoms in the lowest dose and for the shortest possible time. Women should also be examined regularly, including breast screening in accordance with current recommendations, and seek medical help if they notice changes in their breasts.
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