Hospira voluntarily withdraws Endrate

[Guest guest]

www.chicagotribune.com/business/chi-thu_hospira_0117jan17,0,2500855.story

chicagotribune.com

Hospira voluntarily withdraws Endrate

Drug that rids excess calcium in fatal mix-ups

Bloomberg News

January 17, 2008

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 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.

, Chicago TribuneStart the year off right. Easy ways to stay in shape in the new year.