FOSRENOL has the most extensive long-term safety data package of any phosphate binder and is generally well tolerated. Trials involving patients treated with FOSRENOL showed sustained serum phosphorus reduction in a majority of patients, with some patients being followed over a six-year duration.
FOSRENOL is now available in 25 countries, including Spain, Canada,
France, Germany, Italy, and the UK, and continues to be launched in new
markets around the world.
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 patie
|SOURCE Shire Pharmaceuticals|
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