European Body Calls for Halt to Marketing of Hydroxyethyl Starch

[wtbcrna, MSN, DNP, CRNA]

A committee of the European Medicines Agency has called for a suspension of the marketing of infusible hydroxyethyl starch (HES), concluding that the clinical benefits of the products "no longer outweigh their risks."

The recommendation, from the agency's Pharmacovigilance Risk Assessment Committee (PRAC), comes on the heels of three recently published studies suggesting that the products increased the risk for kidney damage in patients with severe sepsis compared with crystalloid therapy. Two of those papers also found that HES solutions appeared to increase the risk for death in patients who received them.

http://www.anesthesiologynews.com/ViewArticle.aspx?d=Web%2bExclusives&d_id=175&i=June+2013&i_id=962&a_id=23434

[WolfpackRed]

this is a bunch of crap. in looking at the FDA statement FDA Safety Communication: Boxed Warning on increased mortality and severe renal injury, and additional warning on risk of bleeding, for use of hydroxyethyl starch solutions in some settings regarding this issue, i felt that the populations studied are already at increased risk for renal damage (critically ill requiring ICU admission and septic) and the volumes used (>2L in over each of the studies cited) are a tad excessive.

Also, the FDA warning states that "Renal injury was not evident in a review of 59 RCTs in which HES products were administered in the operating room to adult and pediatric patients who were undergoing surgery and were followed for a short period of time,

the facility I work in withdrew all HES products from the pharmacy after this warning was issued. I am concerned that it limits may fluid options for patients in the OR (Jehovah's Witnesses who elect to not receive albumin come to mind). Also, the cost of albumin is a concern.

However, given the FDA warning and the European warning, perhaps I should consider investing in albumin manufacturers.

[wtbcrna, MSN, DNP, CRNA]

this is a bunch of crap. in looking at the FDA statement FDA Safety Communication: Boxed Warning on increased mortality and severe renal injury, and additional warning on risk of bleeding, for use of hydroxyethyl starch solutions in some settings regarding this issue, i felt that the populations studied are already at increased risk for renal damage (critically ill requiring ICU admission and septic) and the volumes used (>2L in over each of the studies cited) are a tad excessive.

Also, the FDA warning states that "Renal injury was not evident in a review of 59 RCTs in which HES products were administered in the operating room to adult and pediatric patients who were undergoing surgery and were followed for a short period of time,

the facility I work in withdrew all HES products from the pharmacy after this warning was issued. I am concerned that it limits may fluid options for patients in the OR (Jehovah's Witnesses who elect to not receive albumin come to mind). Also, the cost of albumin is a concern.

However, given the FDA warning and the European warning, perhaps I should consider investing in albumin manufacturers.

I am not sure you know the whole story behind hespan. The main researcher for hespan may have fabricated most or all of the original data.

Top German anesthesiologist’s cardiac surgery paper retracted over “very serious misrepresentations” | Retraction Watch

"In addition, the journal said, it has reason to suspect that data in the paper were fabricated, a possibility that is being investigated by German authorities. As the notice states: it is possible that the study was never performed at all."

[puppies'n kittens]

I quit using the stuff when I heard all the studies had been withdrawn. A study showing poor outcomes in Critically Ill ICU patients and HES predated the withdrawl of the studies. I use nothing but crytalloids, and blood products now.