1. What prompted FDA to make the changes in the physician prescribing information and patient information leaflet for Premarin and Prempro?
The Women's Health Initiative (WHI) conducted a large study sponsored by the National Institutes of Health (NIH) to determine the effects of estrogen plus progestin on the prevention of heart disease. Recent results from this study have shown that postmenopausal women taking estrogen plus progestin have an increased risk of heart attack, stroke, breast cancer, and blood clots.
Wyeth Pharmaceuticals and FDA have worked together to analyze the WHI data and make sure the new risk information is shared with health care providers and women. FDA believes this information needs to be included in the physician prescribing information and patient information leaflet, also referred to as the labeling, for all estrogen and estrogen plus progestin drug products.
2. What is Premarin and what does it treat?
Premarin is a medicine that contains a mixture of estrogen hormones. Premarin is either given alone to a woman without a uterus, or is given in combination with progestin to a woman with a uterus.Premarin is used to:
- reduce hot
flashes in menopause
- treat vaginal
dryness, itching, and burning due to menopause
- help reduce
chances of getting osteoporosis (thin weak bones) in
menopause
- treat certain
conditions in women before menopause if their ovaries do not make
enough estrogen
- ease symptoms of certain cancers that have spread through the body, in men and women.
3. What is Prempro?
Prempro is a medicine that contains two kinds of hormones: estrogens and a progestin. Adding progestin reduces the risk of endometrial cancer in a woman with a uterus. Because Premphase contains the same combination of hormones as Prempro, this document will only refer to Prempro.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)
4. What is menopause?
The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes menopause (the end of monthly menstrual periods) or the "change of life."5. What changes do women go through after menopause?
Every woman experiences menopause differently. Some may not experience any noticeable effects at all.As estrogen levels begin to drop, women may experience changes such as:
- Hot flashes
("hot flushes") - these symptoms can range from feelings of warmth
in the face, neck, and chest, or sudden strong feelings of heat
and sweating.
- Vaginal
changes/vaginal atrophy - the tissues lining the vagina may become
drier, thinner and less elastic.
- Irregular
menstruation - the menstrual cycle may become lighter or heavier
and then stop.
- Sleep
disturbances or night sweats.
- Emotional changes - mood swings, irritability.
6. How many postmenopausal women take estrogen alone or estrogen plus progestin?
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.7. What is the new, important information about Premarin and Prempro and all estrogens and estrogens plus progestins drug products?
Premarin and Prempro, as well as other estrogen and estrogen plus progestin drug products, remain the most effective products available to treat hot flashes and vaginal symptoms of menopause.The major points arising from the WHI study 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.
8. What are the increased risks for women taking estrogen plus progestin?
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 legs
