• 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
FOS 00024 07/08