FDA OKs Once-Yearly Osteoporosis Drug
Reclast Given By IV; First Drug in Class to Be Given Once a Year
Aug. 17, 2007 - The FDA today approved Reclast, the first once-yearly drug for postmenopausal osteoporosis, according to the manufacturer Novartis.
The drug was previously approved by the FDA in April for Paget's disease, which can result in misshapen bones in one or more areas of the body. This is the first indication for the drug for osteoporosis, a disorder that causes bones to break easily.
Reclast is given by infusion. Its active ingredient, zoledronic acid, is also marketed by Novartis under the brand name Zometa for use in certain cancer patients.
The drug belongs to a class of medications called bisphosphonates, which also includes the osteoporosis drugs Actonel and Fosamax, which are usually taken once a week, and Boniva, which is taken monthly. All are in pill form.
Reclast is given as a once-yearly 15-minute intravenous (IV) infusion.
The Research on Reclast
A recent study in The New England Journal of Medicine involving more than 7,700 women showed that Reclast reduced spine fractures by 70% and hip fractures by 41%, compared with placebo. The reduction in spine fractures was sustained over three years.
According to the manufacturer, Reclast increases bone strength and reduces fractures in areas of the body typically affected by osteoporosis, including the hip, spine and other areas such as the wrist, arm, leg, or rib.
"Osteoporosis is a serious disease affecting millions of people in this country," says Leo Schargorodski, executive director of the National Osteoporosis Foundation (NOF), in a Novartis news release. "NOF welcomes new FDA approved treatment options, such as Reclast, that give patients a choice when it comes to taking their osteoporosis therapy."
Reclast is not intended for patients with hypocalcemia (low blood calcium) and those who are allergic to zoledronic acid. Patients already being treated with Zometa should not be treated with Reclast.
Reclast should also not be used during pregnancy because of potential harm to the fetus. And Reclast is not recommended for use in patients with severe kidney impairment.
The most common side effects associated with Reclast are fever; pain in the muscles, bones, or joints; flu-like symptoms; and headache. These symptoms usually occur within the first three days following Reclast administration and usually resolve within three to four days of onset, but resolution could take up to seven to 14 days.
Some patients have reported severe bone, joint, and/or muscle pain after using bisphosphonates. Osteonecrosis of the jaw (damage to the bone) has been reported rarely in postmenopausal osteoporosis patients treated with bisphosphonates. A routine oral examination should be performed by the doctor prior to initiation of treatment, according to the manufacturer.