A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Ferrlecit Side Effects, and Drug Interactions - Sodium ferric gluconate
Ferrlecit Side Effects, and Drug Interactions - Sodium ferric gluconate
SIDE EFFECTS
A total of 385 patients on hemodialysis have been exposed to
Ferrlecit®. Of these, 159 were patients in North American studies and 226
were European patients described in the medical literature.
Flushing and Hypotension: See WARNINGS
Flushing and hypotension have been reported following administration
of Ferrlecit® in European case reports. Of the 226 renal dialysis patients
exposed to Ferrlecit® and reported in the literature, 3 (1.3%) patients
experienced serious hypotensive events which were accompanied by flushing in
two. All completely reversed after one hour without sequelae.
In North American clinical studies the incidence of hypotension
in patients who received Ferrlecit® 62.5mg of elemental iron over 30 minutes
was similar to the incidence of hypotension in patients who received Ferrlecit®
125mg of elemental iron over 60 minutes (34% vs. 36%).
Ferrlecit is intended to be administered during dialysis during
which many patients may experience transient hypotension. Administration of
Ferrlecit® may augment hypotension caused by dialysis.
Among the 159 patients evaluated in North American clinical
studies, one patient experienced a transient decreased level of consciousness
without hypotension. Another patient discontinued treatment prematurely because
of dizziness, lightheadedness, diplopia, malaise, and weakness without hypotension
that resulted in a 3-4 hour hospitalization for observation following drug administration.
The syndrome resolved spontaneously.
Hypersensitivity reactions: See WARNINGS
Although fatal hypersensitivity reactions have not occurred
in the 385 patients exposed to Ferrlecit®, insufficient numbers of patients
may have been exposed to observe this event. The primary Ferrlecit® associated
hypersensitivity events in Study A were Type III reactions that occurred in
three out of a total 88 (3.%) Ferrlecit® treated patients and which resulted
in premature study discontinuation. The first patient withdrew after the development
of pruritus and chest pain following the test dose of Ferrlecit®. The second
patient, in the high-dose group, experienced nausea, abdominal and flank pain,
fatigue and rash following the first dose of Ferrlecit®. The third patient,
in the low-dose group, experienced a "red blotchy rash" following
the first dose of Ferrlecit®. Of the 38 patients exposed to Ferrlecit®
in Study B, none reported hypersensitivity reactions. Hypersensitivity reactions
were not reported in 33 additional patients treated with maintenance Ferrlecit®
in North American studies. This group includes five chronic hemodialysis patients
with a history of anaphylaxis to iron dextran who received up to 1000mg of Ferrlecit®
without an allergic reaction.
Of the 226 renal dialysis patients exposed to Ferrlecit®
and reported in the literature, 2 (0.9%) patients experienced adverse events
that recurred on drug rechallenge and prohibited further drug use. These were:
(1) malaise, heat, vomiting, and loin pain and (2) intense epigastric pain lasting
3-4 hours.
From a total of 387 Ferrlecit® treated patients in medical
reports and North American trials, six patients (1.6%) experienced serious reactions
which precluded further therapy with Ferrlecit®.
Adverse Laboratory Changes: No differences in laboratory findings
associated with Ferrlecit® were reported in North American clinical trials
when normalized against a National Institute of Health database on laboratory
findings in 1,100 hemodialysis patients.
Other Adverse Events Observed During Clinical Trials: Ferrlecit®
has been administered to 159 patients in North American clinical trials. During
these trials, all adverse events were recorded by clinical investigators using
terminology of their own choosing. Adverse events, whether or not related to
Ferrlecit® administration, reported in >1% of Ferrlecit® treated
patients from trials A and B are categorized below by body system using modified
COSTART terminology and ranked in order of decreasing frequency within each
system. Hemodialysis patients may have similar symptoms related to dialysis
itself or to chronic renal failure.
Body as a Whole: injection site reaction, pain, chest pain,
asthenia, headache, abdominal pain, fatigue, fever, malaise, infection, back
pain, rigors, chills, arm pain, flu-like syndrome, sepsis, c(a)arcinoma.
Nervous System: cramps, dizziness, leg cramps, paresthesias,
agitation, insomnia, somnolence.
Respiratory: dyspnea, coughing, upper respiratory infections,
rhinitis, pneumonia.
Cardiovascular System: hypotension, hypertension, syncope,
tachycardia, bradycardia, angina pectoris, myocardial infarction, pulmonary
edema.
Gastrointestinal System: nausea, vomiting, diarrhea, rectal
disorder, dyspepsia, eructation, flatulence, melena.
Musculoskeletal System: myalgia, arthralgia.
Skin and Appendages: pruritus, increased sweating, rash.
Genitourinary System: urinary tract infection.
Special Senses: conjunctivitis, abnormal vision
Metabolic and Nutritional Disorders: hyperkalemia, generalized
edema, leg edema, hypoglycemia, hypokalemia, edema, hypervolemia.
Hematologic System: abnormal erythrocytes, anemia, lymphadenopathy.
DRUG INTERACTIONS
No information is available
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