Evista and Blood clots

What is Evista?

EVISTA (raloxifene HCl) is a prescription medication that prevents and treats osteoporosis in women who have just entered menopause.

What is osteoporosis?

Osteoporosis is a disorder characterized by weak bones which increases the risk of fractures. Osteoporosis means porous bone. The bones in osteoporosis have no mass or strength. The disorder frequently progresses slowly and is painless. In many individuals osteoporosis is not discovered until weakened bones have caused painful fractures usually in the back (spine) or hips. Unfortunately, those individuals who suffer one osteoporotic fracture are more than likely to suffer another fracture. The majority of these fractures are disabling and debilitating. Fortunately, today there are measures that one can take to prevent osteoporosis from ever occurring. The present day treatments can slow the rate of bone loss if you already have developed osteoporosis.

What are risk factors for osteoporosis?

A variety of factors promote osteoporosis. The more risk factors one has, the greater is the chance of developing the disorder. These factors include:

- Caucasian or Asian females

- thin or slender build

- Early menopause

- smokers

- those who consume excess alcohol

- low dietary intake of calcium. milk or vitamin D

- a sedentary lifestyle

- family history of osteoporosis

How Is Osteoporosis Related to Menopause?

It is well known that at menopause there is a drop in the female sex hormone, estrogen. Estrogen is very important for development and strengthening of bone. The estrogen drop during menopause has been directly linked to the development of osteoporosis. Early menopause, lack of dietary calcium, smoking and a sedentary life style all cause significant bone loss.

Can Evista relieve the symptoms of menopause?

Unfortunately No. Evista does not relieve any of the symptoms of menopause.

How does Evista help individuals with osteoporosis?

Evista is used both for the prevention and treatment of osteoporosis in postmenopausal women. It acts by mimicking the natural effects of estrogen on bone tissue. Over time, this slows down the rate of bone breakdown and increase the bone density, thus making the bones stronger and sturdy. Most clinical studies have shown that Evista can significantly reduce the risk of back (spinal) fractures. Its affect on the prevention of hip fractures are not as pronounced.

Does Evista increase the risk of Cancer?

Evista selectively mimics the effects of estrogen on bone tissue, but has no effect on breast or the uterus. This means that long-term use of Evista does not carry the increased risk of cancer of the lining of the womb (endometrial cancer) or breast cancer that is commonly associated with long-term use of estrogen-based hormone replacement therapy (HRT).

What is a major complication of Evista?

Evista is associated with an increased risk of developing blood clots in the veins (deep vein thrombus. This risk is similar to that associated with hormone replacement therapy (estrogen). The blood clots are known to occur in both the deep and superficial veins. The blood clots in the deep veins have the potential to migrate to the lungs (pulmonary embolism), which can result in death



What factors increasing risk of blood clots?

The risk of forming blood clots with Evista is much higher if you have the following risk factors:

- Smoker

- Obese

- Certain blood disorders

- Have had a prior blood clot

- Live an inactive life

- Have had recent surgery (esp. knees or hips)

- Prior stroke or mini stroke



How do I know if I have a blood clot in the legs?

If you are taking Evista and develop a blood clot, you may develop the following symptoms:

- have pain around the calf

- may have a warm sensation around the leg pain or a feeling of warmth in the calves

- swelling around the calf

- may become short of breath

- may cough up blood

- may have a low grade fever

How long before surgery should I stop Evista?

Because of the high risk of developing a blood clot, all individuals who are about to undergo elective surgery, should stop taking Evista at least 3-5 days before the procedure. The medication should not be re-started until one is fully ambulatory. You must notify your doctor that you are taking Evista prior to any surgery.

Who should not take Evista?

Individuals who should not take Evista include:

- those with a clot in the deep veins (deep vein thrombosis)

- those with a clot in the lungs (pulmonary embolism)

- those with cancer of the uterus

- those with damaged kidneys

- those with damaged liver

- those who are pregnant

- those who are breast feeding

Can premenopausal women take Evista?

NO. Evista is only recommended for postmenopausal women. It is not recommended for premenopausal women or children.



What are other side effects of Evista?

The most serious complication of Evista is formation of blood clots in the legs. The other minor side effects include:

- Hot flushes

- General flu-like symptoms

- Leg cramps

- Leg and ankle swelling

- Decreased numbers of platelets in the blood (platelets are important in the formation of a

blood clot)

- Abdominal discomfort

- Bloating

- Nausea and vomiting

- Headaches

- Rash



Is Evista widely prescribed?

Yes, each year millions of prescriptions are filled for the treatment of osteoporosis.

Can I take vitamins with Evista?

Yes. You can take calcium and vitamin D along with EVISTA if you do not get adequate calcium and vitamin D in your diet.

Can I take estrogen supplements with Evista?

The concurrent use of EVISTA and systemic estrogen or hormone replacement therapy has not been studied in prospective clinical trials and therefore concomitant use of EVISTA with systemic estrogens is not recommended.

Final Advice

Before having any surgery, tell your doctor that you are taking Evista. Treatment with Evista may need to be stopped temporarily if you require an extended period of bed rest.