Creams, vaginal estradiol: restricted use to reduce risks of stroke and cancer

Not more than four weeks. And this is the maximum duration for the use of creams-vaginal-based estradiol high dose used to treat the symptoms of atrophy of the vaginal is when it occurs in a natural way, both when it is induced pharmacologically, for example because of a tumour. The recommendation comes from the Committee for Risk Assessment for Pharmacovigilance the EMA (Prac) regarding the creams at the higher dosage, that is, those containing 100 micrograms of estradiol per gram (0,01%). It is feared that their use can cause unwanted side-effects similar to those observed with hormone replacement therapy such as stroke, cancer of the endometrium and breast. The revision of the Ema recommendation arrived these days ago following a review of the one issued in October last, which has been requested by one of the companies that sell creams estradiol high-dose. At the end of the review of the available data on the safety and efficacy of various products of this type, the Prac concluded that in post menopausal women who use them, the levels of estradiol in the blood were detected higher than normal levels for the period post menopausal. That is why it is believed that the absorption of estradiol in the blood can cause unwanted side-effects similar to those observed with hormone replacement therapy (HRT). A single treatment cycle for a month The side effects of HRT taken orally or used transdermally (as patches) include venous thromboembolism (formation of blood clots in the veins), stroke, endometrial cancer (cancer of the lining of the uterus) and cancer of the breast. In addition, there are limited safety data on the long-term use of creams with high dose of estradiol. For this reason, the Prac recommended to limit the use of these creams only one cycle of treatment with a maximum duration of 4 weeks. The warnings on the packaging The Prac has also recommended that the product information for these creams to be updated with the new recommendations indicating on the outer packaging and within the maximum duration of 4 weeks. In addition, the contents of the tube of cream you will be limited to 25 grams of how to prevent use longer than recommended. What are the creams-vaginal-based estradiol cream containing estradiol that fall within this review are those that contain 100 micrograms of estradiol per gram of cream, and not the ones that contain smaller quantities. “These creams, " explains Nicla La Verde , oncologist, director of the research unit of the Fatebenefratelli-the Sack of Milan, and member of the national executive of Aiom - they are part of a type of hormone replacement therapy for topical use. Contain the female hormone estradiol, which is used to replace the natural hormone that decreases in the body after menopause.” The Tos and the risk of developing tumors, The studies that have analysed the increased risk of cancer due to hormone replacement therapy are many, and just recently in the journal The Lancet published a meta-analysis on 58 studies that have taken into account the 108mila women of whom about half had made use of hormones. “All types of TOS, " explains The Green - are associated results in an increase in the risk of breast cancer that grows progressively with the increase of the years of treatment and is higher for therapies that include progestin compared to those based on only estrogen. The likelihood of developing breast cancer over the course of twenty years, from 50 to 70 years, leads to about 63 cases per thousand women among those who had never taken hormones; the risk increases of 7.2 percent in those who use or have used only estrogen, and of 9-10 percent in the women who have followed TOS-continuous estrogen and progestin”. Patients italy's most protected The good news is that in Italy we are not allowed creams containing estradiol indicated for use in the atrophy of the vaginal in post menopausal women. “We have the cream base estradiol but with dosages significantly lower,” explains Sunday, Lorusso , gynaecologist oncologist at the gynaecological Oncology, Foundation Policlinico Universitario Agostino Gemelli, IRCCS, Rome. “In particular, the atrophy of the vaginal we prescribe creams-vaginal-based conjugated estrogen in a dosage of 0.6 milligrams per gram, so with a dose that is 40% lower. Or there are creams estradiol at a dose of 0.025 mg., then even more low”.

Read also: "Atrophy vaginal: suffer from 1 woman to 2 in menopause and 70% of those affected by cancer" Attention to the misuse in general, patients in italy are the most protected but the focus on the use of estrogen must remain high: “What comes from the Ema - highlights Lorusso - is an alert to take into consideration mainly because there may be women who are to solve the problem of the atrophy of the vaginal get these creams with higher doses buying abroad. Others, however, used improperly, those that we have them more often and at higher doses, but so expose themselves equally to a risk”. The fact is that the atrophy of the vaginal can be very debilitating, especially when it affects women very young in the early menopause: “it is important that this risk be aware of not only the women who have already had cancer and are therefore more informed and aware, but also the healthy ones who may not know anything about it,” adds Green. “But some choose also to take on the risk of the Tos for a variety of reasons and in these cases it may be advisable to at least tighten controls on mammographic in order to keep the situation under control”. Dryness vaginal atrophy vulvovaginal suffers from a woman about two in post-menopausal women because the lack of estrogen causes loss of elasticity of the tissues with symptoms such as dryness, itching and even pain during intimate relationships. But this disorder also affects the 70% of women that have been diagnosed with cancer and the girls anorexic. It is a disorder under-treated: for example, it is estimated that in Italy more than half of the women does not, of its own initiative, the problem with your doctor because you are ashamed of it and afraid to be judged evil by those who in the end saved her life. But do not treat the atrophy has implications on the quality of life of the woman and the life of the relationship.

in Addition to the creams of estrogen, you can try to treat this disorder in other ways? “You can use some lubricants and is now used also for the laser vaginal rejuvenation but there is still not a complete acceptance by the scientific community,” says Lorusso.

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