Drugs

Public Citizen Asks FDA to Ban HES Solutions

Public Citizen has petitioned FDA to immediately remove from the market hydroxethyl starch (HES) solutions that have been marketed since 1972 as an option for treating patients who need IV solutions to maintain or increase their fluid volume. The petition says HES solutions should be removed from the market because they cause life-threatening side effects and there are safer, equally available IV solutions readily available.

Soon after the solutions came on the market, Public Citizen says in a news release, evidence emerged that they could impede the blood’s ability to clot properly and that they remained stored in body tissues long after being administered. Later evidence showed that HES solutions can cause kidney failure and death, it says.

In a 2013 safety alert, FDA warned doctors and patients of the side effects and warned against using the solutions in critically ill patients, including those with sepsis, due to the increased risk of death and kidney damage. “However,” Public Citizen says, “the agency, with no justification, allowed the solutions to continue to be used in other patients, including those undergoing major surgery and treatment for trauma, despite evidence showing that HES solutions had the same dangers in all patients.”

Public Citizen says that its petition provides a point-by-point rebuttal, supported by a comprehensive review of the scientific literature, of the arguments offered by the producers of HES solutions and others for keeping the products on the market. It says the petition also asserts that HES solutions offer no unique benefit over several other types of available IV solutions and that there is therefore no justifiable reason to continue to expose patients to the unique risks of HES products.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome