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HRT Is Linked to Deaths From Lung Cancer
Sept. 21, 2009 -- Hormone replacement therapy may raise women's risk of dying from lung cancer.
A new study shows that women who took estrogen-plus-progesterone hormone replacement therapy (HRT) were 71% more likely to die from lung cancer than those who took a placebo.
The study was based on data collected during the Women's Health Initiative (WHI) study, which was halted early when the health risks associated with HRT were found to exceed the benefits. The WHI study found that women who took combined hormone replacement therapy had higher risks of heart disease, stroke, breast cancer, and other health problems.
Although the risk of death from any cause did not differ between the groups at the time the study ended, researchers say additional follow-up now shows a higher risk of lung cancer deaths among women who took combined HRT.
"These findings should be considered before the initiation or continuation of combined hormone therapy in postmenopausal women, especially those with a high risk of lung cancer, such as current smokers or long-term past smokers," write researcher Rowan Chlebowski, MD, of the Los Angeles Biomedical Research Institute at Harbour-UCLA Medical Center in Torrance, Calif., and colleagues in The Lancet.
The WHI study involved 16,608 postmenopausal women at 40 different centers across the U.S. who were randomly assigned to take a daily dose of hormone replacement therapy or a placebo.
During a total of about eight years of follow-up since the WHI study began, researchers found that the incidence of lung cancer was not increased in women who took HRT.
The percentages of women who died from lung cancer from the HRT group and the placebo group were low (0.11% and 0.06%), but statistically significant. When they looked at deaths due to lung cancer, they found 73 women who took HRT died of lung cancer compared with 40 in the placebo group. The researchers found this was mainly due to a higher number of deaths from non-small-cell lung cancer in the combined HRT group.
"These results, along with the findings showing no protection against coronary heart disease, seriously question whether hormone-replacement therapy has any role in medicine today," writes Apar Kishor Ganti, MD, of the University of Nebraska Medical Center in Omaha, in a commentary that accompanies the study. "It is difficult to presume that the benefits of routine use of such therapy for menopausal symptoms outweigh the increased risks of mortality, especially in the absence of improvement in the quality of life."
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VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.
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