Related pages Drug Information Summaries 1 Approval Process for New Cancer Treatments 2 Access to Investigational Drugs 3

This page contains brief information about raloxifene hydrochloride and a collection of links to more information about the use of this drug, related news and research results, and ongoing clinical trials.

US Brand Name(s):		Evista
		Keoxifene
FDA Approved:		Yes

Raloxifene hydrochloride is approved by the Food and Drug Administration (FDA) to decrease the chance of invasive breast cancer in postmenopausal women who have a high risk for developing the disease or who have osteoporosis.

Raloxifene hydrochloride is also approved to prevent and treat osteoporosis in postmenopausal women. It is also being studied in the prevention and treatment of other conditions.

FDA Approval for Raloxifene Hydrochloride ⁴ - Information from the FDA about the approval of this drug and the clinical trials that led to the approval.

Definition from the NCI Drug Dictionary ⁵ - Detailed scientific definition and other names for this drug.

Clinical Trial Results: Osteoporosis Drug Raloxifene Does Not Protect Against Coronary Heart Disease, But Reduces Breast Cancer Risk (08/28/2006) ⁶ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Longer-Term Data Confirm Raloxifene Reduces the Risk of Breast Cancer in Older Women (06/06/2004) ⁷ - Important clinical trial results for this drug, background information, and how the trial was done.

Results of the Study of Tamoxifen and Raloxifene (STAR) Released: Osteoporosis Drug Raloxifene Shown to be as Effective as Tamoxifen in Preventing Invasive Breast Cancer (04/17/2006) ⁸ - Information from the NCI Press Office about this drug.

The Study of Tamoxifen and Raloxifene (STAR): Questions and Answers (04/17/2006) ⁹ - Information about the use of this drug to treat cancer.

Breast Cancer Prevention Studies (07/23/2008) ¹⁰ - Information about the use of this drug to treat cancer.

MedlinePlus Information on Raloxifene Hydrochloride ¹¹ - A lay language summary of important information about this drug that may include the following:

• warnings about this drug,
• what this drug is used for and how it is used,
• what you should tell your doctor before using this drug,
• what you should know about this drug before using it,
• other drugs that may interact with this drug, and
• possible side effects.

Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This NLM patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.

Clinical Trials for Raloxifene ¹² - Check for trials from NCI's PDQ Cancer Clinical Trials Registry now accepting patients.

Glossary Terms

An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled. The Food and Drug Administration also makes sure that drugs, medical devices, and equipment are safe and effective, and that blood for transfusions and transplant tissue are safe. Also called FDA.

Cancer that has spread from where it started in the breast into surrounding, healthy tissue. Most invasive breast cancers start in the ducts (tubes that carry milk from the lobules to the nipple). Invasive breast cancer can spread to other parts of the body through the blood and lymph systems. Also called infiltrating breast cancer.

A condition that is marked by a decrease in bone mass and density, causing bones to become fragile.

Having to do with the time after menopause. Menopause (“change of life”) is the time in a woman's life when menstrual periods stop permanently.

In medicine, action taken to decrease the chance of getting a disease or condition. For example, cancer prevention includes avoiding risk factors (such as smoking, obesity, lack of exercise, and radiation exposure) and increasing protective factors (such as getting regular physical activity, staying at a healthy weight, and having a healthy diet).