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FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women
Date:6/1/2010

placebo-controlled trial of 7,808 postmenopausal women ages 60 to 91 years. In the study, Prolia reduced the incidence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.

The most common side effects reported with Prolia include back pain, pain in the extremities, musculoskeletal pain, high cholesterol levels, and urinary bladder infections. Serious adverse reactions include hypocalcaemia (low calcium levels in the blood), serious infections, including infections of the skin, and dermatologic reactions such as dermatitis, rashes, and eczema.

Prolia causes significant suppression of bone turnover and this suppression may contribute to the occurrence of osteonecrosis of the jaw, a severe bone disease that affects the jaw, atypical fractures, and delayed fracture healing.

Prolia was approved with a risk evaluation and mitigation strategy (REMS) that includes a Medication Guide for patients and communications to health care providers that explains the risks and benefits of the drug.

Prolia is manufactured by Amgen Manufacturing Limited, a subsidiary of Thousand Oaks, Calif.-based Amgen Inc.

For more information

Fast Facts on Osteoporosis – National Institute of Arthritis and Musculoskeletal and Skin Diseases

http://www.niams.nih.gov/Health_Info/Bone/Osteoporosis/osteoporosis_ff.asp

Media Inquiries: Elaine Gansz Bobo, 301.796.7567,

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
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