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Shire Strives to Increase Adherence Among Chronic Kidney Disease Stage 5 Patients

d FOSRENOL in the US alone.

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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