|

Introduction
The few adverse
effects observed during Antizol® (fomepizole)
Injection administration have been brief and of mild to moderate
severity.
Possible laboratory abnormalities have been transient and have
not produced clinical manifestations. Therefore, treatment
with Antizol is considered safe when administered at recommended
doses.
Adverse Reactions
The adverse
reactions listed below are a compilation of effects reported
during clinical trials where investigators indicated the effects
were possibly, probably or definitely related to Antizol, or
the relationship to Antizol was considered unknown. In addition,
these adverse reactions include those reported by healthy volunteers
who received doses that were 6-10 times greater than the recommended
dose (Jacobsen 1988). Due to the clinical manifestations of ethylene
glycol and methanol poisonings, it is difficult to determine whether
each of the reported adverse events is due to the drug or to the existing toxicosis.
The most frequent
adverse events reported in the 78 patients and 63 normal volunteers
who received Antizol were headache (14%), nausea (11%) and dizziness,
increased drowsiness and bad taste/metallic taste (6% each)*.
All other adverse events reported in approximately 3% or fewer
of those receiving Antizol were as follows:
Body as a Whole:
Abdominal pain,
fever, multiorgan system failure, pain during Antizol injection,
inflammation at injection site, lumbagia/backache, hangover.
Cardiovascular:
Sinus bradycardia/bradycardia, phlebosclerosis, tachycardia, phlebitis, shock,
hypotension.
Gastrointestinal
Vomiting, diarrhea, dyspepsia, heartburn, decreased appetite, transient
transaminitis.
Hemic/Lymphatic:
Eosinophilia/hypereosinophilia, lymphangitis,
disseminated intravascular coagulation, anemia.
Nervous:
Lightheadedness, seizure, agitation, feeling drunk, facial flush,
vertigo, nystagmus, anxiety, "felt strange", decreased environmental
awareness.
Respiratory:
Hiccups, pharyngitis.
Skin/Appendages:
Application site reaction, rash.
Special Senses:
Abnormal smell, speech/visual disturbances, transient blurred vision,
roar in ear.
Urogenital:
Anuria
Laboratory abnormalities possibly related
to Antizol treatment include slight transient increases in liver
enzymes, eosinophilia, and elevated triglycerides and/or cholesterol.
(Jacobsen 1990). These effects have not produced clinical manifestations.
Significant laboratory abnormalities observed in patients, such
as increased lactate, azotemia and anemia, are likely due to the
toxins ingested, rather than treatment with fomepizole.
* Minor allergic reactions (rash and eosinophilia) have been reported. Ethylene glycol plasma and urine levels as well as the presence of urinary oxalate crystals in ethylene glycol poisoning and methanol plasma levels in methanol poisoning should be monitored throughout treatment. Dialysis should be considered in some cases.
|