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International Experts Endorse Public Citizen’s Call to Ban Dangerous IV Solutions


International Experts Endorse Public Citizen’s Call to Ban Dangerous IV Solutions

Twenty-Eight Experts Note That Hydroxyethyl Starch Solutions Cause Life-Threatening Side Effects; Safer, Equally Effective and Cheaper Alternatives Are Available

July 13, 2017

Contact: Don Owens, dowens@citizen.org, (202) 588-7767
Angela Bradbery, abradbery@citizen.org, (202) 588-7741

The U.S. Food and Drug Administration (FDA) should require the removal of certain intravenous solutions from the U.S. market because these products trigger severe health consequences, including death, for some patients, experts said in a letter to the FDA today.

Twenty eight internationally recognized researchers in intensive care and related disciplines wrote in support of a February 2017 petition submitted to the FDA by Public Citizen, Dr. Charles Natanson, and Dr. Ian Roberts. That petition requested that the FDA require the removal of hydroxyethyl starch (HES) intravenous solutions from the market in the U.S. because the solutions cause kidney failure, bleeding and increased risk of death, and there are numerous intravenous fluids available in the U.S. that are safer and just as effective as HES solutions.

The authors of today’s letter noted that Public Citizen’s petition offers a point-by-point rebuttal, supported by an exhaustive review of the scientific literature, of the various arguments offered by the producers of HES solutions and others for keeping the products on the market. The petition also explains that HES solutions offer no unique benefit over the other types of intravenous solutions on the market and that there is no compelling reason to continue exposing U.S. patients to the unique risks of HES products.

See the letter here.

See the petition to the FDA here.