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Erythromycin Breath Test Safety
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Clinical Safety Dr. Paul Watkins under IND #31760
first administered the erythromycin breath test in 1988
to patients at the University of Michigan Medical. Since
then several thousand Erythromycin Breath Tests have
been administered to over 1000 patients. No adverse
reactions have been experienced. A few patients have
reported a vague "metallic" taste in their
mouth immediately after the injection, but no other
symptoms have been reported. There have been no IND
safety reports submitted since granting the IND.
Adverse Reactions
Erythromycin is a widely used antibiotic yet very few
significant toxic reactions have been reported during
the more than 40 years that the drug has been in use (1).
Many millions of courses have been administered, but no
death attributable to the medication has been recorded.
Because of this record, erythromycin is considered to
be the safest antimicrobial agent available (2).
Gastrointestinal side effects are by far the most frequent
reactions to the administration of erythromycin. Gastrointestinal
side effects include abdominal pain (sometimes with cramping)
flatulence, diarrhea and modest nausea with vomiting are
noted most frequently. Gastrointestinal toxicity is clearly
dose-related. Adverse effects are relatively infrequent
with the use of <1 gram dosages. Each dose vial of
erythromycin contains less than 0.05 milligrams (20,000
times lower than a typical 1 gram per day erythromycin
therapy). Currently, no reports of gastrointestinal side
effects have occurred with this size preparation.
Allergic reactions to erythromycin are highly unusual.
Hepatotoxicity of erythromycin represents a very rare
event in adults. Hepatoxicity never occurs after a single
dose. The most consistent abnormal laboratory finding
is eosinophia, generally exceeding 500 cells/mm3.
Serum bilirubin and alkaline phosphatase concentrations
are increased in about one-half of affected individuals
and transaminases are uniformly elevated. Cessation of
drug administration promptly reverses signs, symptoms
and laboratory aberrations. No short or long term sequelae
have been detected following cessation of drug (1).
The Erythromycin Breath TestDose contains a 3 µCi dose
of [14C-N-methyl] erythromycin. The 14C dose
emits beta radiation to exposed individuals. The radiation
dose estimate for [14C
N-methyl} erythromycin has been calculated by Dr. Richard
Sparks, Oak Ridge Institute for Science and Education,
Radiation Internal Dose Information Center. The total
effective dose equivalent is 2.1 mrem for a 3 µCi dose
of 14C erythromycin (6.9E-01
rem/mCi). The estimated organ radiation exposures are
shown in the dosimetry
section. The effective dose equivalent is a quantity which
is suitable for comparing risks of different procedures
in nuclear medicine, radiology, and other applications
involving radiation. The estimated total effective dose
contained in theErythromycin Breath Testis comparable
to about one quarter of a chest x-ray and significantly
lower than other nuclear medicine tests. See dosimetry
for more information.
The cosolvents used to solubilize the drug are ethanol,
100% USP and Dextrose Injection, 5%, USP (added separately
to vial prior to administration). Each vial contains 0.4
grams ethanol which corresponds to about 2.5% of one usual
mixed drink. This amount of alcohol is trivial and would
not be expected to cause any toxic reaction in patients.
The concentration of ethanol in the intravenous injection
solution is about 10%, the concentration at which venous
irritation can become significant. A mild venous irritation
at the instillation site in some individuals may occur.
The dextrose injection solution, 4.5 ml added to each
vial to solubilize and dilute drug, is a trivial glucose
load to the body. It is not expected to cause any toxic
reaction in patients.
References
- Eichenwald HF. (1986) Adverse reactions to erythromycin.
Pediatric Infectious Disease 5:147-150.
- Ginsburg CM, Eichenwald HF. (1976) Erythromycin:
A review of its uses in pediatric practice. J Pediatr
89:872-74.
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