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Versenate Side Effects, and Drug Interactions - EDTA - Calcium Disodium Versenate
SIDE EFFECTS
The following adverse effects have been associated with the use of edetate calcium disodium:
Body as a Whole: pain at intramuscular injection site, fever, chills, malaise, fatigue, myalgia, arthralgia.
Cardiovascular: hypotension, cardiac rhythm irregularities.
Renal: acute necrosis of proximal tubules (which may result in fatal nephrosis), infrequent changes in distal tubules and glomeruli.
Urinary: glycosuria, proteinuria, microscopic hematuria and large epithelial cells in urinary sediment.
Nervous System: tremors, headache, numbness, tingling.
Gastrointestinal: cheilosis, nausea, vomiting, anorexia, excessive thirst.
Hepatic: mild increases in SGOT and SGPT are common, and return to normal within 48 hours after cessation of therapy.
Immunogenic: histamine-like reactions (sneezing, nasal congestion, lacrimation), rash.
Hematopoietic: transient bone marrow depression, anemia,
Metabolic: zinc deficiency, hypercalcemia.
There is no known drug interference with standard clinical laboratory tests. Steroids enhance the renal toxicity of edetate calcium disodium in animals. 7 Edetate calcium disodium interferes with the action of zinc insulin preparations by chelating the zinc. 7
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term animal studies have not been conducted with edetate calcium disodium to evaluate its carcinogenic potential, mutagenic potential or its effect on fertility.
Pregnancy: Category B: One reproduction study was performed in rats at doses up to 13 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to Calcium Disodium Versenate. 10 Another reproduction study performed in rats at doses up to about 25 to 40 times the human dose revealed evidence of fetal malformations due to Calcium Disodium Versenate, which were prevented by simultaneous supplementation of dietary zinc. 11 There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
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