HES IV Solutions Recall Pushed By Consumer Group Over Injury Claims
A number of health experts are now joining a prominent consumer watchdog group, calling for the recall of an IV solution commonly used to replace fluids among hospital patients, indicating that it may cause severe bleeding problems, kidney failure and other health risks.
A group of 28 experts in intensive care and associated health care fields wrote a letter (PDF) to the FDA on July 13, supporting a petition filed by the consumer group Public Citizen, which asks the agency to issue a hydroxyethyl starch (HES) IV solution recall.
The recall petition was first submitted by Public Citizen in February, indicating that the risks to patients from HES IV side effects outweigh any benefits.
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HES IV solutions are used to boost fluid volume among hospital patients, and it has been on the market since 1972. However, Public Citizen warns that HES remains in the body’s tissues for long periods of time, can reduce blood clotting ability, and has been linked to kidney failure and death.
“We are writing, as internationally recognized researchers in intensive care and related disciplines, in support of the petition submitted by Public Citizen, Dr. Charles Natanson, and Dr. Ian Roberts to the Food and Drug Administration (FDA) requesting that the FDA require the removal of hydroxyethyl starch (HES) intravenous (IV) 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 letter states. “The 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 therefore no compelling reason to continue to expose patients to the unique risks of HES products.”
The petition states that in 2008, evidence began to emerge indicating that there were problems with HES products. Studies found that patients suffered increased rates of renal failure, bleeding and death. Following a review by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), the committee determined that the risks of HES outweighed its benefits and pushed for suspension of HES market authorizations in Europe.
However, the PRAC revised its recommendations in a split decision following a push by HES solution manufacturers, instead suggesting HES solutions be used only in particular patients and only after alternative solutions were considered not to be effective for that patient.
In 2013, after a review by its own advisers, the FDA required HES IV solutions to carry a black box warning indicating that it should not be used on critically ill patients, such as those with sepsis or in an intensive care unit, and warned of the risk of death and severe kidney injury among those types of patients.
Public Citizen cites a number of studies in the petition which suggested that the FDA’s determination that only those types of patients were at risk was wrong, noting that it relied, in part, on a study conducted by a researcher who has since been discredited for falsifying data and other misconduct during HES solution studies.
The petition calls for an immediate ban on all HES solutions.
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