药品信息:
"Not available for purchase"(不能购买)
Drug that rids excess calcium in fatal mix-ups
Hospira voluntarily withdraws (主动撤回) Endrate
Hospira Inc. has stopped selling the drug Endrate after federal regulators warned that patients, including children, died after mistakenly being given the product or generic versions to treat lead poisoning.
Endrate, known chemically as edetate disodium, was confused with edetate calcium disodium, the Food and Drug Administration said Wednesday, noting both are often called EDTA.
Hospira's drug rids the body of excess calcium. The Lake Forest-based company is voluntarily withdrawing Endrate, spokesman Jason Hodges said. He declined to give sales figures.
The FDA will review Endrate and generics to determine "if the benefits for its intended use continue to outweigh the serious risks," the agency said in a statement posted on its Web site.
The agency cited a 2006 report by the Centers for Disease Control and Prevention of three cases in which patients died, suspected to be because of the mistaken medicine switch: a 2-year-old Texas girl, a 5-year-old Pennsylvania boy and a 53-year-old Oregon woman.
Another child's death early last year was also reported to the FDA "as a result of a mix-up between the two drugs," the regulator said.
Lead poisoning, which stunts mental development, remains a health concern in the U.S., government health officials say. The metal is found in house paint used before 1978 and in toys made outside the U.S., the National Institutes of Health says. Children can swallow chips or dust from lead-based paint, and children in old homes are often likely to be exposed.
The FDA supported the CDC's recommendation that hospitals evaluate whether they need to stock Endrate or generic versions, according to the FDA's statement.
New products exist that can replace edetate disodium, the agency said, while few drugs other than edetate calcium disodium are available to treat severe lead poisoning. Both drugs work through a process called chelation, binding to the unwanted product.
Hospira determined that its product "is no longer medically necessary," Hodges said. Endrate was approved in 1959, according to FDA records. Hospira began in the 1930s as the hospital-products division of North Chicago-based Abbott Laboratories, becoming independent in 2004.
"We've worked with the FDA, and they believe there's a potential problem associated with it that is sufficiently serious enough to remove it from the market," Hodges said.
Hospira is still telling customers of the Endrate withdrawal, Hodges said. The drug is "a relatively small product for us, and there's a lot of alternate medical products available," he added.
Hospira stock rose 30 cents, to close at $42.16, on the New York Stock Exchange.
Copyright © 2008, Chicago Tribune
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Edetate Disodium
( EDTA ) Pronouncation: (EH-duh-tate die-SO-dee-uhm) Class: Cardiovascular agent
Trade Names: Endrate - Injection 150 mg/mL
Pharmacology
Forms chelates with polyvalent metals, especially calcium, thus increasing their urinary excretion.
Pharmacokinetics
Elimination
The chelate formed is excreted in the urine.
Indications and Usage
Emergency treatment of hypercalcemia; control of ventricular arrhythmias associated with digitalis toxicity.
Contraindications
Anuria.
Dosage and Administration
Adults
IV 50 mg/kg/day (max 3 g/day). Usually administered in 5 consecutive daily doses followed by 2 days without medication, with repeated courses as needed, for total of 15 doses.
Dissolve 50 mg/kg dose in 500 mL of D5W or sodium chloride 0.9% for injection. Infuse over 3 h or more.
Children
IV 40 mg/kg/day (max 70 mg/kg/day) or 15 to 50 mg/kg/day (max 3 g/day) with 5 days between courses.
Dissolve drug in sufficient volume of D5W or sodium chloride 0.9% for injection to bring final concentration to 3% or less. Infuse over 3 h or more.
General Advice
Do not confuse edetate disodium with edetate calcium disodium.
Storage/Stability
Store at room temperature.
Drug Interactions
None well documented.
Laboratory Test Interactions
None well documented.
Adverse Reactions
Cardiovascular
Transient drop in BP; adverse reactions on myocardial contractility; thrombophlebitis.
CNS
Transient circumoral paresthesia; numbness; headache.
Dermatologic
Exfoliative dermatitis; toxic skin and mucous membrane reactions.
GI
Nausea; vomiting; diarrhea.
Genitourinary
Nephrotoxicity; damage to reticuloendothelial system.
Hematologic
Thrombophlebitis; anemia.
Metabolic
Electrolyte imbalances including hypocalcemia, hypokalemia, and hypomagnesemia; hyperuricemia.
Miscellaneous
Febrile reactions.
Precautions
Monitor
Hypocalcemia
If signs or symptoms of hypocalcemia occur (eg, circumoral numbness/tingling, positive Chvostek's or Trousseau's signs, tetany), notify health care provider.
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Pregnancy
Category C .
Lactation
Undetermined.
Special Risk Patients
Use drug cautiously in patients with limited cardiac reserve or incipient congestive failure.
Diabetic patients
Blood sugar and insulin requirements may be lower in insulin-dependent diabetic patients.
Hydration
Adequately hydrate patient before administration.
IV infusion
Rapid IV infusion or high serum concentrations can cause a precipitous and potentially fatal drop in serum calcium. Do not exceed maximum dose or rate.
Overdosage
Symptoms
Drop in serum calcium.
Patient Information
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依地酸二钠、依地钠、EDTA-2Na、Edetate Disodium |
药理作用: |
能与钙离子结合成可溶性络合物,以降低血钙浓度,从而降低心肌应激性。 |
剂型剂量: |
注射剂:5ml:1g。 |
作用用途: |
用于房性或室性早搏,尤其是洋地黄中毒引起的室性心律失常,亦用于钙盐过量沉着性疾患,如冠状动脉硬化、周围血管疾病、骨病变钙化、钙盐沉着性关节炎及硬皮病,并可诊断甲状旁腺功能减退。 |
用法用量: |
静注或静滴。成人每次1~3g,以5%GS20~40ml稀释后注入,或每次4~6g,以5%GS500ml稀释后,于1~4小时内滴入,1疗程3~6天,必要时隔7天可重复;小儿每小时15mg/kg,以5%GS稀释后滴入,极量每日60mg/kg。 |
不良反应: |
偶有恶心、呕吐、腹痛,因血钙迅速下降可出现肌肉震颤、抽搐等。 |
禁用或慎用: |
血友病、血液凝固性下降、低血钙、肝或肾脏疾患者忌用。 |
注意事项: |
1、治疗期间应给予低钙饮食。2、定期检查血钙、尿钙含量。3、心律失常纠正后,需口服钾盐,以维持疗效。 |
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