Regulatory Focus™ > News Articles > US Regulators, Defense Officials to Converge for Meeting on Blood Product

US Regulators, Defense Officials to Converge for Meeting on Blood Product

Posted 24 July 2012 | By Alexander Gaffney, RAC 

US regulators are set to reassess the benefits and risks of hydroxyethyl starch (HES) solutions at an upcoming workshop co-sponsored by an unusual combination of federal agencies.

Regulators from the US Food and Drug Administration (FDA) will join along with the Department of Defense (DOD), the National Institutes of Health (NIH)'s National Heart, Lung and Blood Institute and a wide variety of other participants from academia, industry and other stakeholders to discuss the safety of HES products.

The inclusion of DOD officials is relatively unusual, though hardly unprecedented, and speaks to the agency's interest in the safety of a product often used in combat zones.

The product, usually in the form of hydroxyethyl starch 6.0%, is used to prevent the onset of hypovolemia-also known as low blood volume-which can come about through trauma, sepsis, burns or anaphylaxis. FDA's notice explains the products are used in hospital environments "in both military and civilians settings."

A website for BioTime, Inc explains that the product "creates oncotic pressure, which would normally be provided by blood proteins, and permits retention of intravascular fluid." This FDA notes it has approved three HES products-manufactured by Fresnius Kabi (Voluven), BioTime, Inc. (Hextend) and  B. Braun Medical (Hespan)-the first of which was licensed before 1985.

Re-assessing the Safety Risks of HES

While the drugs are reportedly effective in minimizing the effects of blood loss, they are also associated with a number of adverse events, including skin and tissue irritation and disorders, Anaphylaxis, and a decrease in blood coagulation factors.

FDA writes in its Federal Register notice that the public workshop will "serve as a forum for discussing new information on the potential effects of HES solutions on hemostasis and on the renal system." Among the new pieces of information to be discussed: the risks and benefits of HES products and the results of two "major clinical studies" on HES products.

The 6-7 September meeting will take place in Bethesda, MD at the NIH's Building 10 Masur Auditorium.


Read more:

FDA - Public Workshops: Risks and Benefits of Hydroxyethyl Starch Solutions


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