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
Chemet Side Effects, and Drug Interactions - Succimer
Chemet Side Effects, and Drug Interactions - Succimer
SIDE EFFECTS
Clinical experience with CHEMET has been limited. Consequently, the full spectrum
and incidence of adverse reactions including the possibility of hypersensitivity
or idiosyncratic reactions have not been determined. The most common events
attributable to succimer, i.e., gastrointestinal symptoms or increases in serum
transaminases, have been observed in about 10% of patients (see PRECAUTIONS).
Rashes, some necessitating discontinuation of therapy, have been reported
in about 4% of patients. If rash occurs, other causes (e.g. measles) should
be considered before ascribing the reaction to succimer. Rechallenge with succimer
may be considered if lead levels are high enough to warrant retreatment. One
allergic mucocutaneous reaction has been reported on repeated administration
of the drug (See PRECAUTIONS ). Mild to moderate neutropenia has been observed
in some patients receiving succimer (see WARNINGS ). Table I presents adverse
events reported with the administration of succimer for the treatment of lead
and other heavy metal intoxication.
TABLE I
INCIDENCE OF ADVERSE EVENTS IN DOMESTIC STUDIES
REGARDLESS OF ATTRIBUTION OR
SUCCIMER DOSAGE
|
|
Pediatric Patients (191) |
Adults (134) |
|
|
% |
(n) |
% |
(n) |
|
Digestive:
|
12.0 |
23 |
20.9 |
28 |
|
Nausea, vomiting, diarrhea, appetite
loss, hemorrhoidal symptoms, loose stools, metallic
taste in mouth.
|
|
Body as a Whole:
|
5.2 |
10 |
15.7 |
21 |
|
Back pain, abdominal
cramps, stomach pains,
head pain, rib pain, chills,
flank pain, fever, flu-like
symptoms, heavy head/tired, head
cold, headache, moniliasis.
|
|
Metabolic:
|
4.2 |
8 |
10.4 |
14 |
|
Elevated SGPT, SGOT, alkaline
phosphatase, elevated serum
cholesterol.
|
|
Nervous:
|
1.0 |
2 |
12.7 |
17 |
|
Drowsiness, dizziness, sensorimotor
neuropathy, sleepiness, paresthesia.
|
|
Skin and Appendages:
|
2.6 |
5 |
11.2 |
15 |
|
Papular rash, herpetic
rash, rash, mucocutaneous eruptions, pruritus.
|
|
Special Senses:
|
1.0 |
2 |
3.7 |
5 |
|
Cloudy film
in eye, ears plugged, otitis
media, eyes watery.
|
|
Respiratory:
|
3.7 |
7 |
0.7 |
1 |
|
Throat sore, rhinorrhea, nasal
congestion, cough.
|
|
Urogenital:
|
0.0 |
|
3.7 |
5 |
|
Decreased urination, voiding difficulty, proteinuria
increased.
|
|
Cardiovascular:
|
0.0 |
|
1.8 |
2 |
|
Arrhythmia
|
|
Heme/Lymphatic:
|
0.5 * |
1 |
1.5 * |
2 |
|
Mild to moderate neutropenia
|
|
Increased platelet
count, intermittent
eosinophilia.
|
|
Musculoskeletal:
|
0.0 |
|
3.0 |
4 |
|
Kneecap pain, leg
pains.
|
|
|
* Does not include neutropenia
- see WARNINGS
|
DRUG INTERACTIONS
CHEMET is not known to interact with other
drugs including iron supplements; interactions have not been systematically studied.
Concomitant administration of CHEMET with other chelation therapy, such as CaNa
2 EDTA is not recommended.
Drug/Laboratory Tests Interaction: Succimer may interfere with serum and urinary laboratory tests. In vitro studies have shown succimer to cause false positive results for ketones in urine using nitroprusside reagents such as Ketostix® and falsely decreased measurements of serum uric acid and CPK.
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