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 3 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 3 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 nursing or pregnant
• FOSRENOL^® should not be taken by patients who are under 18 years of age