EMA Updates HRT Warning on Ovarian Cancer Risk

European Regulatory Roundup

  Posted 14 January 2016 

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EMA Updates HRT Product Information to Clarify Ovarian Cancer Risk

EMA has updated the product information for hormone-replacement therapy (HRT). The changes follow a review by the Pharmacovigilance Risk Assessment Committee (PRAC) late last year, which concluded EMA should strengthen the warning about the link between HRT and ovarian cancer.
In the previous product information, ovarian cancer was described as a slight risk for people who took HRT for five to 10 years. However, since EMA drafted that version, a meta-analysis published in The Lancet has found shorter-term use of HRT is also associated with a slightly increased risk of the development of ovarian cancer. The publication of data against the hypothesis that only long-term use of HRT puts people at risk of ovarian cancer prompted PRAC and EMA to reassess their position.
Whereas the old text read “long-term (at least 5-10 years) use of oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer,” the revised document states: “Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.”
EMA has also revised a section detailing the number of extra cases of ovarian cancer it would expect to see among people receiving HRT. The regulator now advises that two in every 2,000 women aged 50 to 54 years old who are not taking HRT will develop ovarian cancer over a five-year period. Among women who have been taking HRT for five years, the rate increases to three in 2,000, one extra case per 2,000 people.