|
Related Diseases & Conditions
Hyperphosphatemia can lead to a serious condition, but it may not feel that way
at first. Hyperphosphatemia rarely causes any outward symptoms in the early
stages but, if left untreated, can cause problems in your body. Some of the
serious, and possibly fatal, effects of hyperphosphatemia are:
-
Bone disease — high
phosphorus levels can cause your bones to lose calcium,
leaving them brittle and weak
-
Calcifications and mineral deposits in your body (kidneys, lungs, joints, eyes,
heart and skin)
-
Cardiovascular problems including heart disease and stroke
FOSRENOL® is not indicated for the treatment of secondary hyperparathyroidism, vascular and nonvascular calcification, or cardiovascular or renal bone disease.
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
|
|