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FDA Drug Safety Podcasts
Transcript On January 16, 2008 the Food and Drug Administration issued a public health advisory titled: Edetate Disodium, marketed as Endrate and generic products. I am Pat Clarke from F-D-A's Center for Drug Evaluation and Research. FDA is issuing this public health advisory to alert patients and healthcare professionals about important safety information concerning the drug Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium, also known as Calcium Disodium Versenate or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. These two drugs have very similar names and are commonly referred to only as "EDTA." As a result, the two products are easily mistaken for each other when prescribing, dispensing, and administering them. Because of these safety concerns, FDA is reviewing the benefit/risk profile of Edetate Disodium to determine if the benefits for its intended use continue to outweigh the serious risks. Edetate Disodium and Edetate Calcium Disodium work by binding with heavy metals or minerals in the body allowing them to be passed out of the body through the urine. The FDA originally approved the two drugs for very specific and very different purposes. Edetate Disodium was approved many years ago as an emergency treatment for certain patients with a condition called hypercalcemia, which means having 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. However, there are newer drugs that have been approved since that time that treat these conditions. These newer drugs may also be safer than Edetate Disodium. Edetate Calcium Disodium was also approved many years ago and is still used to reduce dangerously high blood lead levels, also known as severe lead poisoning. This drug is medically necessary because there are very few other drugs available to treat severe lead poisoning. Over time, a number of uses that are not FDA approved for these products have evolved in clinical settings. Among these uses are the removal of other heavy metals from the blood and the treatment of heart disease, specifically, coronary artery disease, commonly referred to as "chelation therapies." The Centers for Disease Control and Prevention published an article in the March 3, 2006 Morbidity and Mortality Weekly Report http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5508a3.htm documenting the deaths of people given Edetate Disodium instead of Edetate Calcium Disodium. FDA was informed earlier this year of an additional child's death as a result of a mix-up between the two drugs. FDA is highlighting the following important safety considerations until the ongoing evaluation of the risks and benefits of Edetate Disodium is complete:
FDA will determine further regulatory actions such as labeling changes or continued marketing of the drug once we complete our evaluation of the safety and efficacy of Edetate Disodium. We urge healthcare providers and patients to report serious side effects that may be associated with the use of Disodium Edetate and Edetate Calcium Disodium to us at the FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot GOV slash M-E-D-W-A-T-C-H. Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash C-D-E-R. Additional Information
Date created: January 18, 2008 |
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