For years, EDTA held a clean record regarding safety but in the past few years, there have been rumors concerning the safety of EDTA. Unfortunately these rumors are true. Due to some poorly trained doctors, hospitals and pharmacies, the wrong medication was incorrectly administered to patients and they were injured or died. EDTA has two forms with administration protocols that are very different. The FDA has issued a public health advisory regarding this very serious recurring prescription drug error. An article was posted by the US Centers for Disease Control and Prevention in 2006 which documented the Edetate Disodium being used instead of Edetate Calcium Disodium. Prior to these fairly resent events, the safety of EDTA when properly administered was unopposed. We submit that if the doctors who caused these disasterous errors were trained by the ACAM (the Academy for Advancement of Medicine), they would be well trained and injuries would not have occurred tarnishing a record that previously enjoyed a long record of safety.
EDTA is often used for “off label” purposes for reduction of heavy metal burden which is believed to cause free radical activity. In alternative medicine, this activity is believed to cause injury to the cardiovascular system and contributes to arteriosclerosis. While it cannot be claimed that EDTA improves arteriosclerosis, it is believed to increase peripheral circulation thereby improving the condition.
Edetate Calcium Disodium is approved to treat severe lead poisoning by the FDA. The FDA is not considering removing it from the market since it is a medically necessary drug with very few other options available to treat lead toxicity. It can safely be administered rapidly by an IV push. Patients with a serum level over 55 mcg/dl and symptomatic should not be given mobilization test. See position paper reference below.
The cause of patient injury comes from an administration error regarding Edetate Disodium. This product is mixed in an IV along with magnesium and administered over a three to four hour period. When administered too rapidly, it lowers the calcium level reducing contractions of the heart.
Everything about this situation is unfortunate. Proper training is essential in eliminating these errors. Products, if stored in the same facility should be marked and stored in separate areas.
Legal Status of EDTA Chelation Therapy – See http://www.acam.org for position paper from American College for Advancement in Medicine on EDTA Chelation Therapy (16 pages)
Included in the paper are the following:
Introduction-‘ACAM was founded in 1973 as a non-profit corporation comprised of approximately 750 licensed physicians many who were interested in and used innovative therapies for ocular vascular disease, degenerative disease and cardiovascular disease.’
Therapeutic History of Chelation Therapy- ‘In simplest of terms EDTA is a man-made amino acid widely recognized as effective for emergency use for hypercalcimia, control of ventricular arrhythmias associated with digitalis toxicity. Due to research at the National Academy of Sciences/National Research Council in the late 1960’s EDTA was indicated for possible consideration in the treatment of occlusive vascular disorders caused by arteriosclerosis….’ Many studies published and referred to in article.
Physician Use of Innovative Therapies- discussion regarding the use of EDTA and addressing concerns thereof and the rights and ethical duty of doctors with the highest regard to public safety.
Restriction to FDA package Insert Guidelines in Inappropriate- regarding off label use of EDTA
Constitutional Considerations in Restricting Choice in Medical Treatment- evolution of patient participation in decision making regarding treatment
First Amendment Protection of Commercial Speech- entitlement to First Amendment protection
Conclusion-Under common law, the state may not deny any individual the right to medical care and access.