EMA recommendation to suspend HES is hazardous.
نویسندگان
چکیده
منابع مشابه
Hydroxyethyl starch - the importance of being earnest
Despite ongoing controversial expert discussions the European Medicines Agency (EMA) recently recommended to suspend marketing authorisations for hydroxyethyl starch. This comment critically evaluates the line of arguments. Basically, the only indication for a colloid is intravascular hypovolemia. Crystalloid use appears reasonable to compensate ongoing extracellular losses beyond. In the hemod...
متن کاملComparison of hydroxyethyl starch regulatory summaries from the Food and Drug Administration and the European Medicines Agency
This article aims to highlight the positions of the Food and Drug Administration and the European Medicines Agency regarding use and marketing of hydroxyethyl starch (HES) products, and how these have changed over recent years. In 2013, warnings from both agencies advised against use of HES in critically ill patients, including patients with sepsis, when several large randomized controlled tria...
متن کاملHydroxyethyl starch solutions and patient harm.
On Jan 26, 2018, the European Medicines Agency (EMA) suspended the marketing authorisations of hydroxyethyl starch (HES) solutions across the European Union.1 These intravenous solutions are often used for plasma volume replacement following acute blood loss. Evidence from highquality, investigator-initiated clinical trials in kidney donors, patients with sepsis, and in critically ill patients ...
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Agriculture research uses "recommendation domains" to develop and transfer crop management practices adapted to specific contexts. The scale of recommendation domains is large when compared to individual production sites and often encompasses less environmental variation than farmers manage. Farmers constantly observe crop response to management practices at a field scale. These observations ar...
متن کاملStarch safety in resuscitation.
The Western Cape Department of Health (WC DoH) has taken a decision to withdraw all intravenous fluids (IVFs) containing hydroxyethyl starch (HES) from hospitals in the Western Cape, with similar action contemplated in the Free State and Gauteng. This was in response to recommendations from: • The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (EMA PRAC) that HES IVFs b...
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ورودعنوان ژورنال:
- Lancet
دوره 391 10122 شماره
صفحات -
تاریخ انتشار 2018