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About Actonel

Actonel 5 mg is indicated for the prevention and treatment of postmenopausal osteoporosis (PMO) in women and glucocorticoid-induced osteoporosis (GIO) in men and women either initiating or continuing systemic glucocorticoid treatment (>7.5 mg/day prednisone or equivalent) for chronic diseases.

In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance<30 ml/min).

In clinical trials, the overall incidence of adverse events with Actonel was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo patients 29.7 percent vs. Actonel patients 29.9 percent), back pain (23.6 percent vs. 26.1 percent), and joint pain (21.1 percent vs. 23.7 percent).

Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia (difficulty swallowing), esophagitis (irritation of the esophagus), and esophageal or gastric ulcers. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.

About the Alliance for Better Bone Health

The Alliance for Better Bone Health was formed by Procter & Gamble and Aventis Pharma in May 1997 to develop and market Actonel collaboratively in Europe, the United States and Canada
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Contact: Jim Guarnera
jguarner@hillandknowlton.com
212-885-0303
Hill and Knowlton
24-Oct-2001