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Edetate Disodium Deaths Prompt FDA Warning

Jan 16, 2008 | Parker Waichman LLP Edetate Disodium has been linked to several deaths, prompting the Food & Drug Administration (FDA) to issue a public health advisory today.   According to the FDA, the defective drug (marketed as Endrate and other generic products) caused the fatalities when it was mistakenly administered to patients in place of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other unapproved uses.

Edetate Disodium and Edetate Calcium Disodium where approved by the FDA to treat very different conditions.  Edetate Disodium was approved many years ago as an emergency treatment for certain patients with a condition called hypercalcemia (very high levels of calcium in the blood) or certain patients with heart rhythm problems as a result of very high amounts of digitalis in the blood.    Edetate Calcium Disodium was also approved many years ago and is still used to reduce dangerously high blood lead levels (severe lead poisoning).    

The FDA said that since their approval, these drugs have been used for a number of unapproved uses.  Among these uses are the removal of other heavy metals from the blood and the treatment of heart disease (coronary artery disease), commonly referred to “chelation therapies.”  The FDA public health advisory includes a reminder that the safety or effectiveness of Edetate Disodium or Edetate Calcium Disodium for use in removing heavy metals and toxins from the body, use in treating coronary artery disease, or other uses not described in the labeling for the product have not been established.  

On March 3, 2006, the Centers for Disease Control and Prevention published an article in the Morbidity and Mortality Weekly Report documenting the deaths of people given Edetate Disodium instead of Edetate Calcium Disodium. The FDA was also informed early in 2007 of an additional child’s death as a result of a mix-up between the two drugs.  Because of the potential for these medication errors to be fatal, the CDC recommended that hospitals evaluate their need to keep Edetate Disodium stocked in their pharmacies.  The FDA said in its health advisory that supports this recommendation as a means of reducing the risk of confusing the two drugs.

As a result of these problems, the FDA said it is reviewing the benefit/risk profile of Edetate Disodium to determine if the benefits for its intended use continue to outweigh the serious risks.  According to the FDA, there are now newer drugs available that are effective remedies for the   conditions that Edetate Disodium was meant to treat. However, Edetate Calcium Disodium is medically necessary because there are very few other drugs available to treat severe lead poisoning.

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