Other safety alerts
|
| |
| The United Kingdom: Hormone replacement therapy (HRT): further information on the known increased risk of breast cancer with HRT and its persistence after stopping |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that new data have confirmed that the risk of breast cancer is increased during use of all types of HRT, except vaginal estrogens, and have also shown that an excess risk of breast cancer persists for longer after stopping HRT than previously thought. Prescribers of HRT should discuss the updated total risk with women using HRT at their next routine appointment.
Systemic HRT is taken orally or applied under or via the skin (as gels or patches [transdermal]) for the relief of vasomotor or related symptoms of the menopause. For women with an intact uterus, progestogen is normally added to estrogen for the prevention of adverse endometrial effects such as hyperplasia and cancer.
On 29 August 2019, a new meta-analysis of participant data from the Collaborative Group on Hormonal Factors in Breast Cancer was published in The Lancet. The analysis included 108,647 cases of breast cancer in prospective studies. The study included long-term follow-up of women who did not use HRT and those who discontinued HRT, mostly in the early 2000s. Among women with complete information, mean HRT duration was 10 years in current users and 7 years in past users.
Key findings of the study include:
· All forms of systemic HRT are associated with a significant excess incidence of breast cancer, irrespective of the type of estrogen or progestogen or route of delivery (oral or transdermal)
· There is little or no increase in risk with current or previous use of HRT for less than 1 year; however, there is an increased risk with HRT use for longer than 1 year
· Risk of breast cancer increases further with longer duration of HRT use
· Risk of breast cancer is lower after stopping HRT than it is during current use, but remains increased in ex-HRT users for more than 10 years compared with women who have never used HRT
· Risk of breast cancer is higher for combined estrogen-progestogen HRT than estrogen-only HRT
· For women who use HRT for similar durations, the total number of HRT-related breast cancers by age 69 years is similar whether HRT is started in her 40s or in her 50s
· The study found no evidence of an effect on breast cancer risk with use of low doses of estrogen applied directly via the vagina to treat local symptoms
Advice for healthcare professionals include:
· a new meta-analysis of more than 100,000 women with breast cancer has shown that some excess risk of breast cancer with systemic HRT persists for more than 10 years after stopping; the total increased risk of breast cancer associated with HRT is therefore higher than previous estimates (see key findings)
· prescribers of HRT should inform women who use or are considering starting HRT of the new information about breast cancer risk at their next routine appointment
· only prescribe HRT to relieve post-menopausal symptoms that are adversely affecting quality of life and regularly review patients using HRT to ensure it is used for the shortest time and at the lowest dose
· remind current and past HRT users to be vigilant for signs of breast cancer and encourage them to attend for breast screening when invited
Please refer to the following website in MHRA and The Lancet for details:
MHRA:
http://www.gov.uk/drug-safety-update/hormone-replacement-therapy-hrt-further-information-on-the-known-increased-risk-of-breast-cancer-with-hrt-and-its-persistence-after-stopping
The Lancet:
http://www.thelancet.com/../fulltext?utm_campaign=PHPfeature&utm_source=PHP&utm_content=TL_MHT
In Hong Kong, hormone replacement therapy (HRT) products are registered pharmaceutical products. So far, the Department of Health (DH) has not received any relevant adverse reaction report related to the drugs. In light of the above MHRA’s announcement, letters to inform local healthcare professionals will be issued. The Drug Office will remain vigilant on safety updates of the drugs by other overseas health regulatory authorities.
Ends/ Saturday, August 31, 2019
Issued at HKT 13:00
|
| |
|
