Prempro (conjugated estrogens/medroxyprogesterone acetate tablets),
Wyeth, contains two kinds of hormones: estrogens and
a progestin. Adding progestin reduces the risk of endometrial cancer
in a woman with a uterus. Wyeth estimates that approximately 5
million U.S. women are taking Premarin and 1.5 million are taking
Prempro. Approximately 10 million postmenopausal women are taking
some form of estrogen, either alone or in combination with a progestin.
Prempro is given to postmenopausal women with a uterus to:
* reduce hot flashes
* treat vaginal dryness, itching, and burning
* help reduce chances of getting osteoporosis (thin weak bones)
Some major points have arisen from a Women's Health Initiative
(WHI) stud, these are:
* Postmenopausal women should not take estrogen and progestin
to protect the heart.
* Estrogens and progestins may increase the risk of heart attack,
stroke, blood clots and breast cancer.
* Although other doses of Prempro and other estrogens and progestins
were not studied, postmenopausal women who take estrogens and progestins
should also be warned about potential risks, which must be presumed
to be the same.
* When these drugs are being prescribed only to prevent osteoporosis,
other treatments should be considered before prescribing estrogen
or estrogen with progestin.
* Estrogens and estrogens with progestins should be used at the
lowest dose for the shortest duration.
The study results show that of every 10,000 women per year taking
Prempro, there would be:
* 8 more cases of breast cancer
* 7 more cases of heart attacks
* 8 more cases of stroke
* 18 more cases of blood clots in the lungs and leg
Some side effects of estrogens and progestins:
Less common but serious side effects include:
* Breast cancer
* Uterine cancer
* Stroke
* Heart attack
* Blood clots
* Gallbladder disease
* Ovarian cancer
Common side effects include:
* Headache
* Breast pain
* Irregular vaginal bleeding or spotting
* Stomach cramps
* Nausea and vomiting
* Hair loss
Specific study findings for the estrogen plus progestin group
compared to placebo include:
* A 41 percent increase in strokes
* A 29 percent increase in heart attacks
* A doubling of rates of venous thromboembolism (blood clots)
* A 22 percent increase in total cardiovascular disease
* A 26 percent increase in breast cancer
* A 37 percent reduction in cases of colorectal cancer
* A one-third reduction in hip fracture rates
* A 24 percent reduction in total fractures
* No difference in total mortality (of all causes)
These are not all the possible side effects of Premarin or Prempro.
For more information, a health care provider or pharmacist should
be consulted.
Long-term risks of Prempro in postmenopausal women include increased
risks of breast cancer and thromboembolic disease associated with
estrogen and combination estrogen/progestin therapy, as well as
increased risk of cardiovascular disease, including myocardial
infarction and stroke, in healthy women. (more)
Prempro Links
Prempro Product Information
Wyeth — Prempro manufacturer
NHLBI
Stops Trial of Estrogen Plus Progestin Due to Increased
Breast Cancer Risk, Lack of Overall Benefit
Systematic Evidence Reviews from the U.S. Preventive Services
Task Force
JAMA article on National Use of Postmenopausal Hormone Therapy
Facts About Postmenopausal Hormone Therapy
Questions and Answers for Estrogen and Estrogen with Progestin
Therapies for Postmenopausal Women
Facts About Postmenopausal Hormone Therapy
NIH Postmenopausal Hormone Therapy
Hormone Therapy -- Latest News
FDA Office of Women's Health, Menopause & Hormones
Estrogens
and Progestins Information Page
More Class Action Lawsuit Information:
Each year in Texas, and throughout the United States, millions
of people are injured through the negligence of companies that
release unsafe or defective products. If you have used or been
exposed to any of these products, we can help. There are statutes
of limitations involved in Texas class actions, so contact us as
soon as possible to protect your rights!
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Court of Appeals.
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