|
During clinical trials, the most
common side effects of FOSRENOL® were gastrointestinal, and included
nausea, vomiting, and diarrhea. Nausea and vomiting generally lessened over
time as patients continued with their treatment.
Patients who stopped treatment usually
reported gastrointestinal side effects as the reason for stopping. Other side
effects reported in trials included dialysis graft complications, headache,
abdominal pain, and low blood pressure.
Although studies were not designed to
detect differences in risk of bone fracture and mortality, there were no
differences demonstrated in patients treated with FOSRENOL® compared
to alternative therapy for up to 3 years.
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 bone 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.
If you suffer from acute stomach
ulcer, colon inflammation and colon ulcers, Crohn's disease, or bowel
obstruction, it is important to know that patients with these conditions were
not included in FOSRENOL® clinical studies — please discuss with
your doctor.
Don't take FOSRENOL® if you
are nursing or pregnant, or if you are under 18 years of age.
|