FDA approves single-dose treatment for Paget's disease

April 23, 2007

The FDA has approved zoledronic acid (Reclast, Novartis) injection as the first new treatment in nearly a decade for patients with the bone condition Paget's disease

The FDA has approved zoledronic acid (Reclast, Novartis) injection as the first new treatment in nearly a decade for patients with the bone condition Paget's disease, which affects approximately one million people in the United States. It is the first treatment for patients to be given as a single-dose infusion, compared with current oral therapies that must be taken daily for up to six months. Reclast is administered as a single, 5-mg, 15-minute intravenous infusion by a healthcare professional. It is contraindicated in patients with hypocalcemia or hypersensitivity to zoledronic acid and in women who are pregnant, could become pregnant, or are breastfeeding. The most common side effects are fever and chills; pain in the muscles, bones or joints; nausea; fatigue; and headache.

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