Katie Lee Joel to Conduct Cooking Demonstration for Local Patients With Chronic Kidn... (day. Number of meals perday may vary. To...)

Katie Lee Joel to Conduct Cooking Demonstration for Local Patients With Chronic Kidney Disease

Date:8/31/2007

day. Number of meals per day may vary. To achieve certain doses, additional tablets may be required.)

FOSRENOL works by binding to dietary phosphorus in the gastrointestinal tract. Once bound, the FOSRENOL/phosphorus complex cannot pass into the bloodstream and is eliminated from the body, thereby decreasing mean serum phosphorus levels.

FOSRENOL has been clinically tested in more than 5,200 patients. Nearly 1,000 patients have been prescribed lanthanum carbonate for more than one year. Over 76,000 patients have been prescribed FOSRENOL. The long-term safety profile of FOSRENOL shows no evidence of toxicity at clinical doses. Trials involving patients treated with FOSRENOL showed sustained serum phosphorus reduction in a majority of patients.

Important Safety Information

The most common adverse events were gastrointestinal, such as nausea and vomiting, and generally abated over time with continued dosing. The most common side effects leading to discontinuation in clinical trials were gastrointestinal events (nausea, vomiting, and diarrhea). Other side effects reported in trials included dialysis graft complications, headache, abdominal pain and hypotension. Although studies were not designed to detect differences in risk of fracture and mortality, there were no differences demonstrated in patients treated with FOSRENOL compared to alternative therapy for up to three years. The duration of treatment exposure and time of observation in the clinical program were too short to conclude that FOSRENOL does not affect the risk of fracture or mortality beyond three years. While lanthanum has been shown to accumulate in the GI tract, liver, and bone in animals, the clinical significance in humans is unknown. Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease, or bowel obstruction were not included in FOSRENOL clinical studies. Caution should be used in patients with these conditions. FOSRENOL should not be taken by patients who are
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Katie Lee Joel to Conduct Cooking Demonstration for Local Patients With Chronic Kidn...(day. Number of meals perday may vary. To...),Health