FDA warns about prescription drug errors involving two medications referred to as ‘EDTA’
The FDA has issued a public health advisory regarding a recurring prescription drug error which has resulted in about a dozen deaths for children and adults who were given the wrong medication. Edetate Disodium and Edetate Calcium Disodium, which are both commonly referred to and prescribed as ‘EDTA’, have been confused for each other by several doctors, hospitals and pharmacists, and the mistakes often result in serious injury or death.
Due the potential risk that the drugs may be mistaken for each other, the FDA is reviewing whether Edetate Disodium should be recalled, as newer drugs are available for the same purpose. Edetate Disodium is approved for emergency treatment hypercalcemia, or high levels of calcium in the blood, as well as heart rhythm problems caused by high amounts of digitalis in the blood. The FDA is recommending that hospitals immediately evaluate whether they have any need to stock Edetate Disodium in their pharmacies, due to the risk of potentially fatal medication confusion.
The other ‘EDTA’ medication, Edetate Calcium Disodium, is approved to treat severe lead poisoning by reducing high blood lead levels. The FDA is not considering removing this drug from the market, since it is a medically necessary drug, with very few other mediations available to treat lead poisoning.
The two drugs are also often prescribed “off-label” for purposes which have not been approved by the FDA or deemed safe. Some of the other uses include treatment of heart disease or for removal of heavy metals from the blood, known as “chelation therapy.”
Problems surrounding the EDTA prescription mistakes were originally documented in an article published by the U.S. Centers for Disease Control and Prevention (CDC) in 2006, which documented deaths caused when individuals were given Edetate Disodium instead of Edetate Calcium Disodium. The FDA also confirmed that several children who were being treated for lead poisoning have died as a result of being given the wrong medication.
Reports suggest that prescription errors and medication mistakes in the United States result in injury or death for as many as one million people a year. Not all of the medication errors involve drugs that have similar names. Problems could be caused by a doctor failing to prescribe the medication properly, a pharmacy filling the drug incorrectly or nurses dispensing the wrong drug.
The medical malpractice lawyers at Saiontz & Kirk, P.A. investigate potential cases for serious injury or death caused by prescription drug mistakes. If you, a friend or family member have been injured by a medication error, request a free claim evaluation.
