Safety of HRT

As well as benefits, HRT has some risks which you need to consider when you're deciding whether to take it, or whether to carry on taking it.

Medical check-ups

Before you start taking HRT, your doctor should ask about your own and your family's medical history. Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination - but only if these examinations are necessary for you, or if you have any special concerns. Once you've started on HRT, you should see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.

Be sure to:

• go for regular breast screening and cervical smear tests
• regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel

Some women need special care

Special care by your doctor may be necessary in some cases.

• Tell your doctor if you have ever had:
  • any disease of the heart or circulation;
  • kidney disease;
  • epilepsy;
  • migraine headaches;
  • high blood pressure;
  • fibroids;
  • endometriosis;
  • diabetes;
  • gallstones;
  • asthma;
  • too much cholesterol or other fatty substances in the blood
  • deafness caused by thickened ear tissue

Estradiol Implants may affect some blood or urine tests.

Effects on your heart or circulation

Heart disease

HRT is not recommended for women who have heart disease, or have had heart disease recently.

If you have ever had heart disease, talk to your doctor to see if you should be taking HRT.

HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated estrogen plus the progestagen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication.

For other types of HRT, the risk is likely to be similar, although this is not yet certain.

If you get:

• a pain in your chest that spreads to your arm or neck

• See a doctor as soon as possible and do not have another implant inserted until a doctor says you can. This pain could be a sign of heart disease.

Stroke

Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:

• getting older
• high blood pressure
• smoking
• drinking too much alcohol
• an irregular heartbeat

If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.

Compare

Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.

For women in their 50s who are taking HRT, the figure would be 4 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.

For women in their 60s who are taking HRT, the figure would be 15 in 1000.

If you get:

• unexplained migraine-type headaches, with or without disturbed vision

• See a doctor as soon as possible and do not have another implant inserted until a doctor says you can. These headaches may be an early warning sign of a stroke.

Blood clots

HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.

These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death.This condition is called pulmonary embolism, or PE.

DVT and PE are examples of a condition called venous thromboembolism, or VTE.

You are more likely to get a blood clot:

• if you are seriously overweight
• if you have had a blood clot before
• if any of your close family have had blood clots
• if you have had one or more miscarriages
• if you have any blood clotting problem that needs treatment with a medicine such as warfarin
• if you're off your feet for a long time because of major surgery, injury or illness
• if you have a rare condition called SLE

If any of these things apply to you, talk to your doctor to see if you should take HRT.

Compare

Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.

For women in their 50s who are taking HRT, the figure would be 7 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.

For women in their 60s who are taking HRT, the figure would be 17 in 1000.

If you get:

• painful swelling in your leg
• sudden chest pain
• difficulty breathing

• See a doctor as soon as possible and do not have another implant inserted until a doctor says you can. These may be signs of a blood clot.

If you're going to have surgery, make sure your doctor knows about it. You may need to avoid taking HRT about 4 to 6 weeks before the operation (eg by delaying your next implant), to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

Effects on your risk of developing cancer

Breast cancer

Women who have breast cancer, or have had breast cancer in the past, should not take HRT. Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking estrogen-only HRT for 5 years is about the same as for a woman of the same age who's still having periods over that time and not taking HRT. The risk for a woman who is taking estrogen plus progestagen HRT is higher than for estrogen-only HRT (but estrogen plus progestagen HRT is beneficial for the endometrium, see "Endometrial cancer" below).

For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping HRT.

Your risk of breast cancer is also higher:

• if you have a close relative (mother, sister or grandmother) who has had breast cancer
• if you are seriously overweight

Compare

Looking at women aged 50 who are not taking HRT - on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.

For women who start taking estrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (ie an extra 1-2 cases).

If they take estrogen-only HRT for 10 years, the figure will be 37 in 1000 (ie an extra 5 cases).

For women who start taking estrogen plus progestagen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (ie an extra 6 cases).

If they take estrogen plus progestagen HRT for 10 years, the figure will be 51 in 1000 (ie an extra 19 cases).

If you notice:

any changes in your breast, such as:

• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel

• Make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining of the womb)

Taking estrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestagen as well as the estrogen helps to lower the extra risk.

If you still have your womb, your doctor may prescribe a progestagen as well as estrogen. If so, these may be prescribed separately, or as a combined HRT product.

If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen without a progestagen.

If you've had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestagen as well as an estrogen. Your product, Estradiol Implants is an estrogen-only product.

Compare

Looking at women who still have a uterus and who are not taking HRT - on average 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

For women who take estrogen-only HRT, the number will be 2 to 12 times higher, depending on the dose and how long you take it.

The addition of a progestagen to estrogen-only HRT substantially reduces the risk of endometrial cancer.

If you get:

breakthrough bleeding or spotting, it's usually nothing to worry about, especially during the first few months of taking HRT.

But if the bleeding or spotting:

• carries on for more than the first few months
• starts after you've been on HRT for a while
• carries on even after you've stopped taking HRT

• Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.

Some studies have indicated that taking estrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.

What other medicines are you taking?

Other medicines may affect how the Estradiol Implant works or estradiol may affect how they work. These include medicines to treat epilepsy (eg phenobarbital, phenytoin, carbamezapine), infectious diseases (eg rifampicin, rifabutin, nevirapine, efavirenz, ritonavir, nelfinavir) and St John's wort.

• Tell your doctor if you are taking (or intend to take) any other medicines.

How much?

The dose is chosen by your doctor.

Usually a dose of 25, 50 or 100 mg is given, but this varies from person to person.

Your doctor will prescribe the lowest dose that relieves your symptoms.

You will need a new implant every 4 - 8 months depending on the size of implant used and how quickly your body uses up estrogen.

As the implant is used up, estrogen levels in the body fall and cause symptoms such as hot flushes, night sweats and mood changes to come back. Hot flushes are a useful sign that you need to renew your implant.

If you do not notice any of these symptoms, then you should arrange your next implant appointment eight months after your first implant.

What may happen when your treatment is finished

If you have not had a hysterectomy, when you finish your treatment with Estradiol implants or your implant has been removed for some reason, your doctor may give you some progestagen tablets to take until withdrawal bleeding stops.

What if you are accidentally given too much?

There is no need to worry. Your doctor may decide not to give you more estrogen until the amount in your body is back to normal.

What to do if Estradiol Implants are swallowed accidentally

If someone has swallowed some implants by accident there is no need to worry. However, you should consult a doctor.

The person may feel sick or be sick. Women may have some vaginal bleeding after a few days.