More Researchers Call For Worldwide HES Ban
A number of researchers from the U.K. and Australia are supporting a call by European regulators for a ban on hydroxyethyl starch solutions (HES), due to the risk of serious adverse health effects.
The researchers published a letter to the Director General of the World Health Organization (WHO) in the medical journal The Lancet on February 12, indicating that evidence suggests that HES is linked to serious health risks, while providing virtually no benefits. The letter comes about a month after the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended HES solutions be removed from the market.
HES intravenous (IV) solutions are used to boost fluid volume among hospital patients, and it has been on the market since 1972. However, critics warn 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.
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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.
In 2013, PRAC recommended that HES solutions administered through IVs be restricted, and said they should no longer be used on critically ill patients. However, the group says now that it has further reviewed drug studies on HES solutions, including clinical trials and observational studies, and has received feedback on stakeholders and experts.
This latest letter calls for the ban to be worldwide, supporting the PRAC’s most recent decision, and noting that the 2013 restrictions were being ignored in many cases.
“The EMA based the decision not only on evidence of harm, but also on the fact that the 2013 decision to restrict the use of HES to non-septic patients with haemorrhagic shock was not being observed in many countries,” the letter states. “HES solutions continued to be used in prohibited populations.”
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.
Last February, the consumer watchdog group Public Citizen, filed a petition with the FDA calling for a ban in the U.S. This summer, a group of 28 experts in intensive care and associated health care fields sent a letter to the FDA supporting the Public Citizen petition.
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