Warnings & Recalls for Edetate Disodium
Serious Alert
- Endrate, the brand name of Edetate Disodium, is no longer available in the U.S., however generic versions of the drug may still be in production and available.
- The FDA has warned medical professionals that the risks of confusing Edetate Disodium with Edetate Calcium Disodium can be deadly. Although both names are associated with the short name EDTA, they are specified for different uses. Patients have suffered severe effects when professionals have used edetate disodium for chelating therapies not approved by the FDA.
Other Warnings
- Patients who have had congestive heart failure, heart diseases and complications, heart rhythm disorders, history of seizures and brain tumors, have had head injuries, diabetes, low potassium levels, trouble urinating, arteriosclerosis (hardened arteries), and have recently taken digitalis should consult with a physician before taking Edetate Disodium.
- Those who are allergic to edetate disodium or any of its ingredients (edetic acid and sodium hydroxide) should not take this drug.
Contraindications:
Contraindications for Edetate Disodium include ziprasidone and pimozide.
Family Planning:
This drug has been classified by the FDA in pregnancy category C, meaning that it may be harmful to the fetus. Patients who become pregnant should discuss the risks of using Edetate Disodium with a physician.
It is unknown whether Edetate Disodium will pass through breastmilk. Nursing mothers should refrain from breastfeeding an infant while on this drug until they have discussed the risks with their doctor.
Edetate Disodium Treatment and Use
What is Edetate Disodium?
Edetate disodium | Endrate is a chelating agent that is used to lower calcium levels in the blood in patients whose levels are dangerously high and used to treat patients with heart rhythm complications caused by excessive digitalis in the blood. However it is different than the the drug Edetate Calcium Disodium which is used to treat lead poisoning using the same chelating treatment. Both drugs use this chelating agent to pass the heavy metals through the urine.
How does Edetate Disodium work?
Edetate Disodium chemically binds (chelates) to metals and minerals in the blood, virtually stopping the negative effects of the excess metals and minerals by producing a serum after binding. After the chelate is formed, the solution will be excreted in the urine over the next 24 hours.
Dosage Information
Edetate Disodium is given intravenously by a medical professional with an infusion rate over 3 hours, for at least 5 consecutive days with one day of rest, completing a set. Sets should be repeated, as much as 15 times, until calcium levels return to a healthy level.
For adults the recommended dosage is 50 mg per kg of a patient’s body weight, not to exceed 3 g in 24 hours.
After patients receive Edetate Disodium, they will need to remain in a lying position, as the lowering of calcium levels can naturally cause a drop in blood pressure. Patients will need to be closely watched to monitor effects and calcium levels.
