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Dangerous IV Solutions Must Be Banned Immediately, Public Citizen Tells FDA

Feb. 8, 2017

Dangerous IV Solutions Must Be Banned Immediately, Public Citizen Tells FDA

Hydroxyethyl Starch Solutions Cause Life-Threatening Side Effects; Safer, Equally Effective and Cheaper Alternatives Are Available

WASHINGTON, D.C. – A type of intravenous (IV) solution used mainly in hospitals should be taken off the market because it causes life-threatening side effects and safer, equally effective IV solutions are readily available, Public Citizen said today in a petition to the U.S. Food and Drug Administration (FDA). Joining Public Citizen as co-petitioners are two internationally recognized experts in critical care medicine.

Hydroxyethyl starch (HES) solutions have been marketed since 1972 as an option for treating patients who need IV solutions to maintain or increase their fluid volume. Three branded versions are available in the U.S.: Hespan (made by B. Braun Medical, Inc.), Hextend (made by BioTime, Inc.) and Voluven (made by Fresenius Kabi Norge A.S.).

Soon after 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. 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.

In 2013, the FDA issued a safety alert warning doctors and patients of these side effects and warned against using HES solutions in critically ill patients, including those with sepsis, because of the increased risk of death and kidney damage. However, 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.

Also in 2013, a key committee of the European Medicines Agency (EMA) voted to ban HES solutions in Europe, only to reverse the decision a few months later in a split decision, with 14 of the 33 members of the committee voting against the reversal and issuing a dissenting opinion that detailed the reasons the risks of HES solutions outweighed their (nonunique) benefits in all patients.

In its petition, Public Citizen offers a point-by-point rebuttal – supported by a comprehensive review of the scientific literature – of the arguments offered by the producers of HES solutions and others for keeping the products on the market. The petition also explains that HES solutions offer no unique benefit over several other types of available intravenous solutions and that there is therefore no justifiable reason to continue to expose patients to the unique risks of HES products.

“The evidence on the dangers of HES solutions is overwhelming,” said Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group and a co-author of the petition. “There is no good justification, other than corporate profits, to subject any patient to these dangers when there are so many equally effective but much safer alternatives available.”

In addition to Public Citizen, two other co-petitioners, signing on their own behalf, are leading experts on critical care and fluid management. Both joined 74 other experts around the world in co-signing a 2014 open letter to the EMA that urged the agency to ban HES solutions in Europe.

One co-petitioner is Dr. Charles Natanson, who has published extensively on the risks of HES products, including three papers as part of his work as a senior investigator and chief of the Anesthesia Section in the National Institutes of Health’s (NIH’s) Clinical Center’s Critical Care Medicine Department.

“HES fulfills no unmet medical need, and there are excellent alternatives available without the unacceptable toxicities of HES,” said Natanson. “The FDA and EMA should fulfill their mission to protect the public health and, without delay, ban HES solutions in the U.S. and Europe.”

The other co-petitioner, Dr. Ian Roberts, coordinating editor of the Cochrane Injuries Group and co-director of the Clinical Trials Unit at the London School of Hygiene & Tropical Medicine, added, “Medicines should be licensed for use only if they are safe and effective. HES products are clearly not and should be banned worldwide.” Roberts also has published several articles on the risks of HES products.

In addition to filing a petition with the FDA, Public Citizen and its two co-petitioners sent a copy of the petition to the EMA’s executive director, Dr. Guido Rasi, along with a letter urging the EMA to reconsider its 2013 decision and ban HES products in Europe.