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FDA Approves Actonel & reg with Calcium

By Pharmaceutical Processing | August 17, 2005

The FDA has approved Actonel with Calcium (risedronate sodium tablets with calcium carbonate tablets, USP), a product that provides the fracture protection of Actonel tablets conveniently packaged with calcium tablets. Actonel with Calcium is the first prescription osteoporosis therapy to include calcium.

“Osteoporosis is a serious, widespread and growing public health threat,” said Judith Cranford, Director, National Osteoporosis Foundation. “The NOF welcomes any new FDA approved treatment options, such as Actonel with Calcium, that will help patients address this all too prevalent disease.”

Actonel with Calcium is a prescription therapy indicated for the prevention and treatment of postmenopausal osteoporosis. Actonel with Calcium includes four weeks of therapy. Each week contains seven tablets (one 35 mg once-a-week Actonel tablet and six tablets that each provide 500 mg calcium). This new treatment option comes in light of the recent Surgeon General’s Report on Bone Health and Osteoporosis which emphasizes the need for osteoporosis regimens to be simplified and organized.

“Calcium is a critical component to the effectiveness of osteoporosis therapy,” said Steven Goldstein, MD, Professor of Obstetrics and Gynecology, at the New York University School of Medicine. “Actonel with Calcium is an important new tool that helps simplify the osteoporosis regimen by conveniently delivering two important elements — the bisphosphonate and the calcium — in one unique package.”

Calcium is a basic building block of bone and is essential for maintaining bone health. Despite this, two new surveys suggest that many women may not take enough calcium or may take it incorrectly with a bisphosphonate therapy like Actonel. According to a study conducted by Information Resources, Inc. (IRI), 73 percent of women who filled a bisphosphonate prescription purchased less than the equivalent of one calcium tablet per day. A second survey conducted by Harris Interactive(R) revealed that one in four U.S. women aged 50 and over (26 percent) take calcium within 30 minutes of their bisphosphonate, which decreases the effectiveness of the bisphosphonate. Both surveys were conducted on behalf of The Alliance for Better Bone Health.

“Many women need to understand the importance of how to follow a proper daily calcium regimen to realize the full effectiveness of an osteoporosis regimen that includes a bisphosphonate,” said Goldstein. “The Actonel with Calcium packaging system offers women a new way to take their Actonel and their calcium correctly and consistently.”

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