Fresenius, B. Braun IV Fluids Tied to More Deaths, Study Finds

A type of intravenous solution made by Fresenius SE and B. Braun Holding GmbH that’s used to treat shock has a 10 percent higher risk of death than another treatment, an analysis by U.K. researchers found.

Hospitals should stop using hydroxyethyl starch solution, or colloid fluid, and instead give patients saline-based crystalloid fluids, according to Ian Roberts, the doctor who led the review of data from 25 previous studies that was published today by the Cochrane Library.

“There is no evidence of benefit” from colloid products, “they are more expensive and there is almost certain harm,” Ian Roberts, a professor at the London School of Hygiene and Tropical Medicine, said in a telephone interview. “The trial compared using saline- and starched-based fluids. There was less death in the saline group. The obvious thing to do is to switch to a saline.”

Colloid and crystalloid fluids are used to stabilize patients with low blood pressure caused by conditions including dehydration or blood loss, shock and organ damage from blood infections. Roberts estimated that 75 percent of patients receiving the treatment in the U.K.’s state-run National Health Service are given the colloid version. The European Medicines Agency said in November that it was reviewing the safety of solutions containing hydroxyethyl starch.

Fresenius, based in the Frankfurt suburb of Bad Homburg, is the world’s top seller of hydroxyethyl starch. Matthias Link, a spokesman for Fresenius, said the company also makes saline- based crystalloid fluids and is reviewing the data from the Cochrane study. The colloid product accounts for a “low single- digit sales volume” at the company’s Kabi intravenous-device and treatment division, he said.

“The question is, what helps more in these cases where there are very sick patients who have had serious blood loss?” Link said. “Without such a blood volumizer they would die. If I give one volumizer or another, how can I help more patients survive?”

Closely held B. Braun, based in Melsungen, Germany, is a competitor on the colloid product. The company declined to comment on the data because it hadn’t had a chance to review it before publication, spokeswoman Mechthild Claes said in an e- mail.

“The respective issues, however, are already addressed in the ongoing EMA procedure,” Claes said.

Colloid fluid is used widely in Europe, the U.K. and Canada, though not as widely in the U.S., Roberts said. He said he has written to the U.K. Department of Health asking its National Health Service to stop using colloid fluids.

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To contact the reporter on this story: Andrea Gerlin in London at agerlin@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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