FDA to Debate Starch Treatment

The US Food and Drug Administration will consider whether or not to stop the use of intravenous starch solutions to replace lost blood.

By | August 31, 2012

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Injecting starchy solutions directly into the veins of patients who are suffering from sepsis—dangerously low blood pressure often caused by systemic infection—may do more harm than other treatments, according to recently published research. And next week, scientists at the US Food and Drug Administration (FDA) will mull whether or not to discontinue the treatment based on this and other emerging information.

A study published month in the New England Journal of Medicine (NEJM) found that 201 of 398 patients given a particular brand of hydroxyethyl starch died, compared to only 172 of 400 who received a different IV fluid called Ringer's acetate. Copenhagen University Hospital researcher and physician Anders Perner, lead author on the NEJM study, told Nature that he stopped using IV starch treatment for sepsis as soon as the study's findings became clear. “We changed practice the day we saw the results," he said. "Many Scandinavian ICUs have done the same."

But physicians all over the world, and especially intensive care unit (ICU) doctors, still use the treatment, including in the United States. While ICU docs and researchers are split over whether or not IV starch is a safe and effective sepsis treatment, FDA scientists meeting in Maryland next week will discuss the agency's stance on the issue.

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