"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
In a "...
(Generic versions may still be available.)
See WARNING statement, page 1.
Rapid intravenous infusion or attainment of high serum concentration of edetate disodium may cause a precipitous drop in the serum calcium level and many result in fatality. Toxicity appears to be dependent upon both total dosage and speed of administration. The rate of administration and dosage should not exceed that indicated in DOSAGE AND ADMINISTRATION.
Because of its irritant effect on the tissues and because of the danger of serious side effects if administered in the undiluted form, Endrate (Edetate Disodium Injection, USP) should be diluted before infusion. See DOSAGE AND ADMINISTRATION.
After the infusion of edetate disodium, the patient should remain in bed for a short time because of the possibility of postural hypotension.
The possibility of an adverse effect on myocardial contractility should be considered when administering the drug to patients with heart disease. Caution is dictated in the use of this drug in patients with limited cardiac reserve or incipient congestive failure. Edetate Disodium Injection, USP therapy should be used with caution in patients with clinical or subclinical potassium deficiency states. In such cases it is advisable to perform serum potassium blood levels for possible hypokalemia and to monitor ECG changes.
The possibility of hypomagnesemia should be kept in mind during prolonged therapy.
Do not use unless solution is clear and container is intact. Discard unused portion.
Renal excretory function should be assessed prior to treatment. Periodic BUN and creatinine determinations and daily urinalysis should be performed on patients receiving this drug.
Because of the possibility of inducing an electrolyte imbalance during treatment with edetate disodium, appropriate laboratory determinations and studies to evaluate the status of cardiac function should be performed. Repetition of these tests is recommended as often as clinically indicated, particularly in patients with ventricular arrhythmia and those with a history of seizure disorders or intracranial lesions. If clinical evidence suggests any disturbance of liver function during treatment, appropriate laboratory determinations should be performed and withdrawal of the drug may be required.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Definitive statements cannot be made due to insufficient data and conflicting information.
Pregnancy Category C
Animal reproduction studies have not been conducted with Edetate Disodium Injection. It is also not known whether Edetate Disodium Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Edetate Disodium Injection should be given to a pregnant woman only if clearly needed.
The safety of this product in nursing mothers has not been established.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Endrate (edetate) ® did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/27/2009
Additional Endrate Information
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