Public Citizen Calls for a Recall of IV Solutions
July 6, 2017
Public Citizen, a nonprofit organization that fights for consumer rights, has called on the Food and Drug Administration (FDA) to take action against a dangerous intravenous solution that is commonly used in hospitals.
Hydroxyethyl starch, also known as HES, has been on the market since 1972. There are three different brands available for use in the U.S.: Voluven, Hespan and Hextend. HES is given to patients when they need to maintain or increase the volume of fluids in their body.
Although the FDA has not pulled HES from the market, it did release a consumer warning in 2013. The warning advised patients and doctors alike that HES has dangerous side effects, such as kidney damage or complete failure. The FDA has advised medical professionals to avoid using HES on critically ill patients, because data found that it increased the chance of death.
Other data has found that HES is particularly dangerous to use on patients who have severe sepsis or septic shock. Research shows that HES comes with a higher risk for kidney problems with those patients, and can also cause blood coagulation irregularities as well as bleeding.
As a result of these dangers and the health concern, Public Citizen is petitioning the FDA to once again consider removing hydroxyethyl starch from the market. According to their petition, there are two main types of intravenous solutions: colloidal and crystalloid. HES is a colloidal solution. These solutions are similar to crystalloid ones, but have added starch or protein.
Because the FDA first approved HES in 1972, the regulatory standards that allowed for it to get on the market were different and less strict than they are today. One example of this is that many patients who received HES during medical trials were observed for periods of time under 24 hours.
In Europe, HES was nearly banned before a dissenting opinion was published, which claimed that HES offers medical benefits to patients that are valid enough to continue using it. But, research shows that HES offers the same benefits as other intravenous solutions that are readily available on the health market so its benefits are non-unique and outweighed by the serious hazards.
As a result of HES still being used and putting patients at risk, Public Citizen has joined together with experts around the world in hopes of fighting enough to get the FDA to ban it. Public Citizen has also been urged the EMA to once again reconsider banning the solution, so that patients across the globe are protected against unnecessary medical damages or even death.
One of Public Citizen’s researchers in the organizations Health Research Group has said that there is no excuse for HES to still be on the market, especially since there are safe alternatives. He argues that the other IV solutions available are just as effective and come without the risk of death or kidney failure.
So far, the FDA’s only response has been to warn doctors against using HES solutions on patients who have sepsis or are in septic shock, are in the intensive care unit, or are critically ill. According to the agency, not enough data has been uncovered to justify pulling HES from the market completely.
Public Citizen’s petition argues that HES should be immediately removed from the market in order to save thousands of patients from unnecessary medical complications, dangers and death. Because there are other safe options for intravenous solution use, it is advisable to talk to your doctor about your health concerns.
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