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FDA calls for new warning labels on hydroxyethyl starch products

Posted 08 July 2021 | By Joanne S. Eglovitch 

FDA calls for new warning labels on hydroxyethyl starch products

The US Food and Drug Administration (FDA) on Thursday says it is requiring new safety warnings for hydroxyethyl starch (HES) products in light of reports of death, kidney injury and excessive bleeding associated with these products.
 
HES treatments are used to stabilize patients experiencing severe blood loss. The announcement follows up on an FDA safety review of these products from randomized clinical trials, meta-analyses, and observational studies. Through this review, the agency concluded that “changes to the Boxed Warning are warranted to highlight the risk of mortality, kidney injury, and excess bleeding, as well as to include a statement that HES products should not be used unless adequate alternative treatment is unavailable.”
 
There are currently three FDA-approved HES innovator products on the market: HESPAN, 6% hetastarch in 0.9% sodium chloride injection; made by B. Braun Medical, HEXTEND, 6% hetastarch in lactated electrolyte injection made by BioTime, and Voluven, 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, made by Fresenius Kabi.  There is also one approved generic version of HESPAN that is distributed in the US (6% hetastarch in 0.9% sodium chloride injection) made by Hospira.
 
In reaching the decision to make the labeling changes, FDA relied on a meta-analysis as well as retrospective and observational studies that “collectively show increased risk of mortality” and acute kidney injury (AKI) in patients undergoing surgery who receive HES. The meta-analysis looked at 15 randomized controlled trials, finding a safety signal for increased risk of AKI and renal replacement therapy (RRT) in 4,409 surgical patients treated with HES products. The meta-analysis review was published in the August 2014 issue of Netherlands Journal of Critical Care.
 
Other retrospective and observational studies in a variety of surgical populations also found increased risk of AKI, RRT and coagulopathy, noted FDA.
 
For blunt trauma patients, receipt of HES products was associated with not only AKI, but also increased risk of mortality in two retrospective studies.
 
Excess bleeding when surgical patients received HES products was also seen in one small randomized controlled trial and a larger retrospective study.

This is not the first time that regulators have sounded alarm bells for these products: in 2013, the FDA and the European Medicines Agency issued warnings for these treatments, saying they had several worrisome side effects (RELATED: FDA adds serious new warnings to hydroxyethyl starch products, but falls short of EMA’s restrictions, Regulatory Focus 26 June 2013)
 
FDA announcement
 
 
 

 

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