Hydroxyethyl Starch IV Solution Recall Urged Due to Life-Threatening Side Effects

A prominent consumer watchdog group indicates that an IV solution used to replace fluids among hospital patients should be removed from the market, due to the risk that it may cause severe bleeding problems, kidney failure and other life-threatening side effects. 

Public Citizen filed a petition (PDF) with the FDA on February 8, calling for a recall of hydroxyethyl starch (HES) IV solutions, including Hespan, Hextend, and Voluven. The group says HES side effects are too dangerous, and notes there are other IV solutions available that do the same job, without exposing patients to the same serious risks.

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.

“The evidence on the dangers of HES solutions is overwhelming,” Dr. Sammy Almashat, a Hespanresearcher with Public Citizen’s Health Research Group and a co-author of the petition said in a press release. “There is no good justification, other than corporate profits, to subject any patient to these dangers when there are so many equally effective but much safer alternatives available.”

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 advisors, 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.

“The harms of HES products to patients outweigh their very modest fluid-saving effects, and these solutions should not be used in any patient population, including in surgical, trauma, and pediatric patients,” the petition states. “HES products should be immediately removed from the market to prevent further harm to thousands of patients.”