The Wall Street Journal-20080117-FDA Warns 2 Disodium Drugs Can Be Mistaken for Each Other
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FDA Warns 2 Disodium Drugs Can Be Mistaken for Each Other
WASHINGTON -- The Food and Drug Administration warned of mix-ups and deaths involving two older drugs with similar names, one of which is used to treat severe lead poisoning.
The agency also warned against using the drugs, which the FDA said are commonly both referred to as EDTA, for unapproved uses such as "chelation therapy" to remove metals from the blood.
The FDA said edetate disodium is approved to treat patients with high levels of calcium in the blood, while edetate calcium disodium is approved to treat lead poisoning. Edetate calcium disodium is also referred to as calcium disodium versenate, the FDA said.
"These two drugs have very similar names and are commonly referred to only as 'EDTA,'" the FDA said in a public-health advisory. "As a result, the two products are easily mistaken for each other when prescribing, dispensing and administering them."
The agency said it has received almost a dozen reports of deaths among children and adults in the past 30 years, including more recent reports of children being treated for lead poisoning who were accidentally given the wrong disodium drug.
The Centers for Disease Control and Prevention also detailed some of the disodium-related deaths in a 2006 report, and said one of the deaths involved a child with autism who underwent treatment with one of the drugs in an attempt to remove mercury from the blood.
The FDA said edetate calcium disodium is medically necessary to treat severe lead poisoning, but questioned whether the other drug was still needed. The agency said other drugs have since been approved to treat high levels of calcium in the blood, and a certain heart-rhythm disorder that edetate disodium was originally approved to treat.
The FDA said it is currently considering whether it will allow edetate disodium to be sold in the U.S.
Meanwhile, the FDA said hospitals should consider whether they even need to keep edetate disodium stocked in their pharmacies, and should consider only keeping edetate calcium disodium, the lead-poisoning drug.
The agency said children and adults who are to be treated for lead poisoning should only be given the edetate calcium disodium form of EDTA. The FDA also said the full chemical name should be used when prescribing or dispensing an order for either of the drugs, and the abbreviation EDTA shouldn't be used.
