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FDA Approves New Once-a-Month Dose of Actonel for Postmenopausal Osteoporosis
Date:4/24/2008

Bisphosphonates, including Actonel, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcers. Actonel should be taken according to the dosing instructions to minimize the risk of these events. Patients should discontinue use if new or worsening symptoms occur.

There have been reports of severe and occasionally incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates. Rare occurrences of osteonecrosis, primarily of the jaw (ONJ), have been reported in patients treated with bisphosphonates. Most cases were reported in cancer patients receiving intravenous bisphosphonates, but some have been in patients treated orally for osteoporosis. Most cases were reported in patients undergoing dental procedures such as tooth extraction.

Most common adverse reactions reported in >10% of patients treated with ACTONEL and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely.

Please see full prescribing information for Actonel(R) (risedronate sodium) tablets for additional safety information. For more information on Actonel please visit http://www.Actonel.com.

About The Alliance for Better Bone Health

The Alliance for Better Bone Health was formed in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe. It is a collaboration between Procter & Gamble Pharmaceuticals and sanofi-aventis U.S.

About Procter & Gamble (NYSE: PG)


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SOURCE The Alliance for Better Bone Health
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