November 2009


SUMMARY
Estrogens have important uses, but they have serious risks as well. You must decide, with your doctor, whether the risks are acceptable to you in view of the benefits of treatment. Except where your doctor has prescribed estrogens for use in special cases of cancer of the breast or prostate, you should not use estrogens if you have cancer of the breast or uterus, are pregnant, have undiag-nosed abnormal vaginal bleeding, clotting in the legs or lungs, or have had a stroke, heart attack or angina, or clotting in the legs or lungs in the past while taking estrogens.
You can help your doctor prescribe estrogens as safely as possible by understanding that he will require regular physical examinations while you are taking them and will try to discontinue the drug as soon as he can and use the smallest dose possible. Be alert for signs of trouble including:
1. Abnormal bleeding from the vagina.
2. Pains in the calves or chest or sudden short
ness of breath, or coughing blood (indicating pos
sible clots in the legs, heart, or lungs}.
3. Severe headache, dizziness, faintness, or
changes in vision (indicating possible developing
clots in the brain or eye).
4. Breast lumps (you should ask your doctor how
to examine your own breasts).
5. Jaundice (yellowing of the skin).
6. Mental depression.
‘The above information is the officially approved statement of the U.S. Food and Drug Administration.
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OTHER EFFECTS OF ESTROGENS
In addition to the serious known risks of estrogens described above, estrogens have the following side effects and potential risks:
1. Nausea and vomiting. The most common side
effect of estrogen therapy is nausea. Vomiting is
less common.
2. Effects on breasts. Estrogens may cause
breast tenderness or enlargement and may cause
the breasts to secrete a liquid. These effects are not
dangerous.
3. Effects on the uterus. Estrogens may cause
benign fibroid tumors of the uterus to get larger.
Some women will have menstrual bleeding when estrogens are stopped for one week each month. But if the bleeding occurs on days you are still taking estrogens you should report this to your doctor.
4. Effects on liver. Women taking oral contra
ceptives develop on rare occasions a benign turnor
of the liver which can rupture and bleed into the
abdomen. So far, these tumors have not been re
ported in women using estrogens in the meno
pause, but you should report any swelling or un
usual pain or tenderness in the abdomen to your
doctor immediately.
Women with a past history of jaundice (yellowing of the skin and white parts of the eyes) may get jaundice again during estrogen use. If this occurs, stop taking estrogens and see your doctor.
5. Mental depression. A few women develop
depression while on estrogen therapy. If you have
had depression in the past, it may reappear or get
worse during estrogen therapy. If you do become
severely depressed, stop taking estrogens and call
your doctor.

6. Other effects. Estrogens may cause excess fluid to be retained in the body. This may make some conditions worse, such as epilepsy, migraine, heart disease, or kidney disease.
A spotty darkening of the skin can develop, particularly in the face, and may persist.
SUMMARY
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ESTROGEN (Estrogenic Substances) Conjugated Estrogens, Esterified Estrogens {Estrone and Equilin)
BRAND NAMES

USA
Amneslrogen (Squibb) Conestrone (Wyeth) Evex (Syntex) Fernogen (Fellows) Genisis (Organon) Menest (Beecham) Menotabs (Fleming) Premarin (Ayerst) SK-Estrogens (Smith Kline
& French)
Theogen (Sig: Pharm.) Formatrix [CD] (Ayerst) Menrium [CD] (Roche) Milprem [CD] (Wallace) PMB-200 [CD] (Ayerst) PMB-400 [CD] (Ayerst)

CANADA
Climestrone (Frosst) Conjugated Estrogens
(Sands)
Menotrol (Squibb) Oestrilin (Desbergers) Premarin (Ayerst) Formatrix [CD] (Ayerst) Menrium [CD] (Roche)

WHAT YOU SHOULD KNOW ABOUT ESTROGENS
Estrogens are female hormones produced by the ovaries. The ovaries make several different kinds of estrogens. In addition, scientists have been able to make a variety of synthetic estrogens. As far as we know, all these estrogens have tne same properties and therefore much the same usefulness, side effects, and risks. This leaflet is intended to help you understand what estrogens are used for, the risks involved in their use, and how to use them as safely as possible.
This leaflet includes the most important information about estrogens, but not all the information. • If you want to know more, you can ask your doctor or pharmacist to let you read the package insert prepared for the doctor.
USES OF ESTROGEN
Estrogens are prescribed by doctors fora number of purposes, including:
1. To provide estrogen during a period of ad
justment when a woman’s ovaries no longer pro
duce it, in order to prevent certain uncomfortable
symptoms of estrogen deficiency. (All women nor
mally stop producing estrogens, generally between
the ages of 45-50; this is called the menopause.)
2. To prevent symptoms of estrogen deficiency
when a woman’s ovaries have been removed sur
gically before the natural menopause.
3. To prevent pregnancy. (Estrogens are given
along with a progestogen, anotherfemale hormone;
these combinations are called oral contraceptives

or birth control pills. Patient labeling is available to women taking oral contraceptives and they will not be discussed in this leaflet.)
4. To treat certain cancers in men (cancer of the
prostate or breast) and in women (certain cancers
of the breast when they occur more than 5 years
after menopause).
5. To prevent painful swelling of the breasts after
pregnancy in women who choose not to nurse
their babies,
THERE IS NO PROPER USE OF ESTROGENS IN A PREGNANT WOMAN.
ESTROGENS IN THE MENOPAUSE
In the natural course of their lives, all women eventually experience a fall in estrogen production. This usually occurs between ages 45 and 50 but may occur earlier or later. Sometimes the ovaries may need to be removed before natural menopause by an operation, producing a “surgical menopause.”
When the amount of estrogen in the blood begins to decrease many women may develop typical symptoms: Feelings of warmth in the face, neck, and chest or sudden intense episodes of heat and sweating throughout the body (called “hot flashes” or “hot flushes”). These symptoms are sometimes very uncomfortable. A few women eventually develop changes in the vagina (called “atrophic vaginitis”) which cause discomfort, especially during intercourse.
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THE DANGERS OF ESTROGENS
1. Cancer of the uterus. If estrogens are used in the postmenopausal period for more than a year, there is an increased risk of endometrial cancer (cancer of the uterus). Women taking estrogens have roughly 5 to 10 times as great a chance of getting this cancer as women who take no estrogens. To put this another way, while a postmenopausal woman not taking estrogens has one chance in a 1,000 each year of getting cancer of the uterus, a woman taking estrogens has one chance in 100 to 200 each year. For this reason /( is important to take estrogens only when you really need them.
The risk of this cancer is greater the longer estro-

gens are used and also seems to be greater when larger doses are taken. For this reason it is important to take the lowest dose of estrogen that will control symptoms and to take it only as long as it is needed. If estrogens are needed for longer periods of time, your doctor will want to reevaluate your need for estrogens at least every six months. Women_ using estrogens should report any irregular vaginal bleeding to their doctors; such bleeding may be of no importance, but it can be an early warning of cancer of the uterus. If you have undiagnosed vaginal bleeding, you should not use estrogens until a diagnosis is made and you are certain there is no cancer of the uterus.
2. Other possible cancers. Estrogens can cause
development of other tumors in animals, such as
tumors of the breast, cervix, vagina, or liver, when
given for a long time. At present there is no good
evidence that women using estrogens in the meno
pause have an increased risk of such tumors, but
there is no way yet to be sure they do not. This is a
further reason to use estrogens only when clearly
needed. While you are taking estrogens, it is im
portant that you go to your doctor at least once a
year to check on your uterus, cervix, vagina, and
breasts. Also, if members of your family have had
breast cancer or if you have breast nodules or
abnormal mamrnograms (breast x-rays), your
doctor will want to carry out especially careful
examination of your breasts.
3. Gall bladder disease. Women who use estro
gens after menopause are about 2-1/2 times as
likely to develop gall bladder disease needing sur
gery as women who do not use estrogens. Birth
control pills have a similar effect.
4. Abnormal blood clotting. Oral contraceptives
increase the risk of blood clotting in various parts
of the body. This can result in a stroke (if the clot
is in the brain), a heart attack (clot in a blood vessel
of the heart), or a pulmonary embolus (a clot which
forms in the legs or pelvis, then breaks off and
travels to the lungs). Any of these can be fatal.
At this time use of estrogens in the menopause is not known to cause such blood clotting, but this has not been fully studied and there could still prove to be such a risk. It is recommended that if you have had a heart attack, angina, or stroke, or if you have had clotting in the legs or lungs associated with use of estrogens or birth control pills, you should not use estrogens (unless they are being used to treat cancer of the breast or prostate).
The larger doses of estrogen used to prevent swelling of the breasts after pregnancy have been reported to cause clotting in the legs and lungs.drugsdcom drugxscom drugsxcom drugzscom drugszcom drugsxcom drugscxom drugsdcom drugscdom drugsfcom drugscfom drugsvcom drugscvom drugsciom drugscoim drugsc9om drugsco9m drugsc0om drugsco0m drugscpom drugscopm drugsclom drugscolm drugsckom drugscokm drugsconm drugscomn drugscojm drugscomj drugscokm drugscomk

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ESTROGENS TO PREVENT SWELLING OF THE BREASTS AFTER PREGNANCY
If you do not breast feed your baby after delivery, your breasts may fill up with milk and become painful and engorged. This usually begins about 3 to 4 days after delivery and may last for a few days to up to a week or more. Sometimes the discomfort is severe, but usually it is not and can be controlled by pain relieving drugs such as aspirin and by binding the breasts up tightly. Estrogens can be used to try to prevent the breasts from filling up. While this treatment is otten successful, in many cases the breasts fill up to some degree in spite oi treatment. The dose of estrogens needed io prevent pain and swelling of the breasts is much larger than the dose needed to treat symptoms of the menopause and this may increase your chances of .developing blood clots in the legs or lungs (see below). Therefore, it is important that you discuss the benefits and the risks of estrogen use with your doctor if you have decided not to breast feed your baby.rugs dugs drgs drus drug ddrugs drrugs druugs druggs drugss rdugs durgs drgus drusg srugs erugs rrugs frugs crugs xrugs deugs d4ugs d5ugs dtugs dgugs dfugs ddugs drygs dr7gs dr8gs drigs drkgs drjgs drhgs drufs druts druys druhs drubs druvs druga drugw druge drugd drugx drugz sdrugs dsrugs edrugs derugs rdrugs drrugs fdrugs dfrugs cdrugs dcrugs xdrugs dxrugs derugs dreugs d4rugs

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