The Food and Drug Administration (FDA) recently released a Public Health Advisory on Edetate Disodium (EDTA). The advisory reflects FDA’s current analysis of data available concerning this drug. The advisory is meant to alert patients and healthcare professionals about EDTA.
In this relatively innocent looking letter, the FDA is warning hospital pharmacies that there have been 11 deaths associated with di-sodium EDTA since 1971. They indicate that to improve safety and avoid potential medical errors, hospitals may want to consider not carrying di-sodium EDTA. Finally, they hint they may be revisiting di-sodium EDTA’s safety record at some point in time.
They are responding to the death of a child in 2003 year because the physician mixed up di-sodium with Calcium EDTA. Medical errors do take place and the majority of these reported cases. In fact it is known that 450 people die each year from acetaminophen poisoning. With the millions of di-sodium EDTA treatments each year, this product has a better safety record than Tylenol®.
The FDA is, of course, forbidden to regulate the practice of medicine but that doesn’t stop them from pushing the envelope. Every time they have tried, they have lost in court. One of the most important cases was the FDA v. Evers in 1978. Guess what the drug in question was? Yes, di-sodium EDTA. So they never give up even when they have had their hands slapped.
In addition to the public advisory, the FDA is suggesting that they are revisiting the safety of di-sodium EDTA, essential for the treatment of cardiovascular disease to remove calcium from blocked arteries, while encouraging the use of Calcium-EDTA, which cannot remove the calcium plaque because it is already bonded to Calcium.
This is the same agency that refuses to classify the mercury component in dental fillings, which puts between 42 and 57 tons of mercury into people’s bodies every year. The agency that has stated it may be unethical to try to find out whether mercury is “safe” in people’s bodies. Also the same agency that approved Vioxx that killed 50,000 people and approved Viagra that killed well more than 11 people in its first week of use! Yet, they are focused on the safety of di-Sodium EDTA because of potential confusion about treatment.
The American Association for Health Freedom is very concerned about where the FDA may take this. The FDA cannot approve or disapprove of how a legally marketed drug is used by a physician in his practice. The agency approves of what a manufacturer may recommend about uses in its labeling (package insert) and advertising. We are meeting with our team of attorneys to make sure our response to this new threat to this very effective and inexpensive treatment for cardio-vascular disease. We will be working with the physician groups that use di-sodium EDTA to make sure this unnecessary concern the FDA is displaying is not used as an excuse to end this effective and safe treatment.