Tag Archives: treatment

HES Solutions Warrant Additional Box Warning

The U.S. Food and Drug Administration (FDA) has found data that indicate an increased risk of mortality and renal injury requiring renal replacement therapy in critically ill adult patients treated with hydroxyethyl starch (HES) solutions. HES solutions are used for the treatment of hypovolemia when plasma volume expansion is indicated. After a public workshop, the FDA concluded that HES solutions should not be used in this patient population, and a Boxed Warning to include the risk of mortality and severe renal injury is warranted. In addition, the FDA reviewed a meta-analysis of studies conducted in patients undergoing open heart surgery in association with cardiopulmonary bypass and determined that an additional warning about excessive bleeding was needed in the Warnings and Precautions Section of the package insert. The FDA has created a list of recommendations for patients and healthcare providers to consider before use of HES solutions.

PDR Drug Alerts provides immediate, electronic delivery of safety information from the U.S. Food and Drug Administration. Society of Critical Care Medicine members can sign up to receive complimentary alerts as well as updates reflecting labeling changes.

Hong Kong Warns of New Coronavirus

new coronavirus is on the loose, and Hong Kong and world health authorities are taking notice. The virus has killed 11 of the 17 people known to have contracted it, a death rate much higher than that of severe acute respiratory syndrome (SARS). Unlike SARS, which affected the respiratory system, this new virus, dubbed “novel coronavirus,” attacks multiple organs. The most likely source of this new disease is bats, though monkeys, pigs, civet cats and even rabbits can also harbor it. To be prepared, Hong Kong officials have started conducting simulations in the event of an outbreak, including quarantines and treatment protocols. The new potential outbreak seems to be centered in the Middle East, with several cases linked to travelers who visited Qatar, Jordan and Saudi Arabia. The Society will continue to monitor this situation and will keep members abreast of any new information.