Reclast Approved as Once-Yearly Osteoporosis Drug
For postmenopausal women
MONDAY, Aug. 20, 2007 (HealthDay News) -- The Novartis drug Reclast (zoledronic acid) has been approved by the U.S. Food and Drug Administration as a once-yearly treatment for postmenopausal osteoporosis, the company said Monday.
In a clinical study involving more than 7,700 women, Reclast reduced the risk of spine fracture by 70 percent and hip fracture by 41 percent, the company said in a statement. The drug is administered as a 15-minute intravenous injection.
The most common side effects reported were pain in the muscles, joints, or bones; flu-like symptoms, and headache.
Osteoporotic fractures lead to about 800,000 emergency room visits, 500,000 hospitalizations, 180,000 nursing home placements, and 2.6 million doctor visits each year, costing up $17.9 billion annually, Novartis said.
In April, Reclast was approved to treat another bone disorder, Paget's disease, which affects about 1 million people in the United States.
Visit this FDA page to learn more about osteoporosis.