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Lilly Granted Temporary Restraining Order to Halt Launch of Generic Raloxifene
Date:3/9/2009

dulator (SERM), recently classified by the FDA as an estrogen agonist/antagonist, is indicated for the treatment and prevention of osteoporosis in postmenopausal women; and the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and the reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.

Important Safety Information about EVISTA(R) (raloxifene HCl tablets)

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.

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SOURCE Eli Lilly and Company
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