Drugs

Public Citizen Wants IV Solution Banned

Public Citizen says that hydroxyethyl starch (HES) solutions that are used mainly in hospitals should be removed from the market because they cause life-threatening side effects and there are safer, equally effective IV solutions readily available. A news release from the advocacy group (containing a link to a petition requesting the action) says that the solutions have been marketed since 1972 as an option for treating patients who need IV solutions to maintain or increase their fluid volume. Branded versions available in the U.S. are manufactured by B. Braun, BioTime, and Fresenius.

“Soon after the HES solutions came on the market, evidence emerged that they could impede the blood’s ability to clot properly and that they remained stored in body tissues long after being administered,” the statement says. “Later evidence showed that HES solutions can cause kidney failure and death. That such evidence emerged only after the solutions were approved was not surprising, given that their approval was based on small, brief, and poorly designed clinical trials.”

Public Citizen says that in 2013 FDA issued a safety alert warning doctors and patients of the side effects and warning against using HES solutions in critically ill patients, including those with sepsis, because of the increased risk of death and kidney damage. “However,” it says, “the agency, with no justification, allowed the solutions to continue to be used in other patients, including those undergoing major surgery and treatment for trauma, despite evidence showing that HES solutions had the same dangers in all patients.”

The petition provides what the advocacy group says is a point-by-point rebuttal, supported by a comprehensive review of the scientific literature, of the arguments offered by HES solution producers and others for keeping the products on the market. It also is said to explain that HES solutions offer no unique benefit over several other types of available intravenous solutions and that there is thus no justifiable reason to continue to expose patients to the products’ unique risks.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome