TIME TO RE-EXAMINE
The warnings on menopause treatment drugs are more than 20 years old, and have been shown to be based on an imperfect understanding, he said
By Chiu Chih-jou
/ Staff reporter
The warning labels for risks from menopausal hormone therapy (MHT) in Taiwan should be updated, as they are based on a study from more than 20 years ago and newer studies indicate the risks are more age-dependent, Taiwanese Menopause Society president Lai Tsung-hsuan (賴宗炫) said yesterday ahead of International Women’s Day today.
Women experience continuous hormonal changes throughout their lives, particularly after entering menopause, which can cause symptoms including hot flashes, night sweats and insomnia.
Many women choose to endure the symptoms rather than seek treatment, as studies have indicated that MHT might increase the risk of breast cancer and cardiovascular disease.
Photo: Taipei Times
The US Food and Drug Administration announced the removal last year of “black box” safety warnings regarding risks of cardiovascular disease, breast cancer and dementia from most MHT products.
Lai, a reproductive medicine specialist, said the risks from MHT are actually highly dependent on the patient’s age and the timing of use, but the warning labels in Taiwan remain unchanged from 20 years ago.
He recommended that these labels be updated based on the latest evidence, allowing women to feel safe getting MHT under a physician’s assessment.
The 2002 Women’s Health Initiative study reported a 26 percent increased risk of invasive breast cancer in postmenopausal women taking combined estrogen plus progestin, leading to an early halt of the trial and an immediate decline in MHT use, Lai said.
About one-third of postmenopausal women in Taiwan were using MHT before the study was published, and at one point, it declined to only about 1 percent of postmenopausal women, he said.
The study had an average participant age of 63, which generally began using MHT more than a decade past menopause, which is a different medical environment from the women aged between 50 to 59 who are the most common age group seeking such treatment clinically, Lai said.
Follow-up studies that reanalyzed the data by age found different results, he said, adding that based on evidence, initiating MHT before the age of 60 would not increase the risk of breast cancer and might even provide cardiovascular benefits, while there might be an increase in risk if started after the age of 60.
Lai said MHT not only improves menopausal symptoms such as hot flashes, night sweats and sleep disturbances, but also helps reduce bone loss and prevent osteoporosis.
It is commonly used to treat genitourinary symptoms of menopause, including vaginal dryness, recurring vaginitis and urinary tract infections, he added.
The benefits of taking MHT are generally considered to outweigh the risks for women who experience premature menopause before the age of 50, he said, adding that beginning use within 10 years of menopause or before age 60 is considered the best timing, in terms of safety and efficacy.
Estrogen and progesterone are the main MHT used clinically, but they should be carefully assessed if the patient has a history of breast cancer, blood clots, vaginal bleeding or liver dysfunction, Lai said.
Menopausal symptoms are very common, with more than 80 percent of women experiencing some form of discomfort during the perimenopausal transition, which lasts an average of eight years, he said.
Over the past two to three years, the proportion of postmenopausal women using MHT has grown to about 15 to 20 percent, Lai said, adding that it remains lower in Taiwan than the 20 percent or higher in Europe and North America.
While pharmaceutical companies in the US were required to remove certain outdated warnings last year, Taiwan’s labels are more than 20 years old, so the association calls on Taiwan’s Food and Drug Administration to review and update these guidelines, so that women can feel safe getting treatment after a doctor’s assessment and improve their quality of life.