EDTA Medication Errors Linked to Patient Deaths

MedScape ^ | January 17, 2008 | Yael Waknine

[CholeraJoe]

January 17, 2008 — Inadvertent and inappropriate administration of edetate disodium (Endrate, Hospira, Inc, and generics) can lead to serious adverse events, the US Food and Drug Administration (FDA) warned healthcare professionals yesterday.

Inadvertent use of edetate disodium rather than edetate calcium disodium (also known as calcium disodium versenate) has led to deaths in adults and children, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.

According to the FDA, the major risks are thought to apply only to the short period of time after edetate disodium use; onset of death and serious reactions were all reported within minutes to hours following administration.

Eleven reports of death were reported with use of edetate disodium from 1971 through 2007; most recently, 1 report was received in 2003 and 2 in 2005, and 1 additional case was reported in 2007. Nine of the deaths followed administration of edetate sodium, and the identifier "EDTA" was associated with 2 additional cases.

Because both edetate disodium and edetate calcium disodium share a mechanism of action (binding with heavy metals or minerals in the body to allow their urinary excretion), have very similar names, and are commonly referred to as "EDTA," errors can occur when they are prescribed, dispensed, or administered, the FDA said.

However, approved indications differ for the agents. Edetate disodium is approved for use as an emergency treatment for certain patients with hypercalcemia or heart rhythm problems resulting from high serum levels of digitalis. Edetate calcium disodium is indicated for the treatment of severe lead poisoning.

When substituted for edetate calcium disodium therapy, edetate disodium is likely to cause severe decreases in blood calcium levels and to lead to death in patients requiring treatment for severe lead poisoning.

Over the next several weeks, the FDA will be evaluating the risks and benefits of edetate disodium therapy. In the interim, the FDA and the Centers for Disease Control and Prevention recommend that hospitals and other facilities consider whether it is wise to stock both drugs, especially edetate disodium, because of the risk for medication errors.

If both drugs remain available, the full product name should be used when prescribing and dispensing the appropriate product. Consideration should be given to including the indication with the prescribing order, which should be checked to confirm appropriate drug use before administration. Patients suffering from lead poisoning should only receive edetate calcium disodium.

The agency also warned that deaths have also been reported in association with off-label use of these products as chelation therapies, purported to cleanse the body of heavy metals and toxins, treat autism, or improve the cardiovascular system. The safety and efficacy of edetate disodium and edetate calcium disodium for these indications has not been established.

Adverse events related to use of edetate disodium and edetate calcium disodium should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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[CholeraJoe]

Medication errors alert.

[CholeraJoe]

And yet people still believe chelation therapy can cure all man’s ills.

[Born Conservative]

Just ask that family from England how well it works to “cure” autism; the child died after being “chelated” with EDTA.

[Pharmboy]

These people who administer chelation therapy and those that receive it are unfamiliar with evidence-based medicine.

[chicagolady]

ALOT of things might kill you, does the FDA really care??

http://www.relfe.com/Aspartame_92.html

Note: This information required a Freedom Of Information Act request to pry it from the reluctant hands of the FDA.

Nutrasweet (brand name for Aspartame) was not approved until 1981, in dry foods. For over eight years the FDA refused to approve it because of the seizures and brain tumors this drug produced in lab animals. The FDA continued to refuse to approve it until President Reagan took office (a friend of Searle) and fired the FDA Commissioner who wouldn’t approve it. Dr. Arthur Hull Hayes was appointed as commissioner. Even then there was so much opposition to approval that a Board of Inquiry was set up. The Board said: “Do not approve aspartame”. Dr. Hayes OVERRULED his own Board of Inquiry.

[darth]

Oral chelation using small daily doses is much safer than the IV treatment especially if the combination includes calcium and trace minerals. The drug companies hate chelation; they want to sell statins, stents, etc. Howver, chelation works. It really does remove calcified plaques from your cardiovascular system; I’ve seen the research and stats. BTW, been taking it daily (VRP’s Oral Chelator and Advanced Minerals) for over 3 years now.