EVISTA® (raloxifene HCl): Risk to Bones and Breasts

Risk to Your Bones and Breasts

The following facts and statistics may help you better understand how osteoporosis and invasive breast cancer can impact women, and reinforce the importance of learning if you are at risk.

Osteoporosis

Osteoporosis can strike at any age and affects people of all ethnic backgrounds
- Did you know? Osteoporosis is under-recognized and under-treated not only in Caucasian women, but African-American women as well
Osteoporosis is a health threat for an estimated 55% of those 50 years of age and older in the U.S.
- Did you know? 22 million women have low bone mass and are at increased risk for osteoporosis — and 8 million already have the disease

The Danger of Fracture

Up to 50% of women over age 50 will have a broken bone related to osteoporosis in their remaining lifetime
- Did you know? Osteoporosis is responsible for more than 1.2 million fractures annually in women in the U.S.
One third of American women over the age of 50 will eventually have a fracture of the spine
Almost 20% of women will have another break within 1 year of a fracture in the spine

Like millions of women past menopause, you could be at risk. The more you understand osteoporosis, the more empowered you will be to take steps to prevent and treat this serious disease. Learn more about your bones and the stages of osteoporosis.

Invasive Breast Cancer
Although invasive breast cancer affects a relatively small percentage of women, the following facts should be considered by all women past menopause:

The chance of developing invasive breast cancer at some time in a woman's life is about 1 in 8 (12% of women)
- Did you know? An estimated 178,000 new cases of invasive breast cancer will be diagnosed among women in the United States in 2007
Women living in North America have the highest rate of invasive breast cancer in the world*
- Did you know? About 40,460 women will die from invasive breast cancer in the United States in 2007

*According to the American Cancer Society, approximately 75% of breast cancer cases are invasive.

Important Safety Information

EVISTA is not for everyone. Serious side effects can occur while taking EVISTA.

EVISTA may cause an increased risk of blood clots. You should not take EVISTA if you have had or are at risk for getting blood clots in the legs, lungs, or eyes. Stop taking EVISTA and call your doctor if you have swelling or feeling of warmth in your legs, chest pain, shortness of breath, coughing up blood or sudden changes in vision, as these may be signs of a blood clot. Being unable to move around for long periods may increase this risk. If you will need to be still for a long time, talk to your healthcare professional about ways to reduce the risk of blood clots.

In a study of women past menopause who were at high risk for heart attack, EVISTA increased the risk of dying from a stroke. However, EVISTA did not increase the risk of heart attack, stroke, or dying from other causes. Before taking EVISTA, tell your healthcare professional if you have had a stroke, mini-stroke, irregular heartbeat, high blood pressure, heart attack, history of smoking, or believe you have other risk factors for stroke or a heart attack.

You should not take EVISTA if you are nursing, pregnant, or may become pregnant, as it may harm your baby. If you have kidney or liver problems, you should talk to your healthcare professional about these conditions before taking EVISTA. Do not take EVISTA with estrogen in the form of pills, patches, or injections.

The most common side effects are hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. In clinical trials, side effects were usually mild enough that most women did not stop taking EVISTA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For more safety information, and important information for patients taking EVISTA, see the Medication Guide.