Statement of Dr. Sammy Almashat, Researcher, Public Citizen’s Health Research Group
Note: Today, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended the removal from the market of all hydroxyethyl starch (HES) intravenous (IV) solutions in Europe. Public Citizen last year petitioned the FDA to remove HES IV solutions from the market.
We applaud the decision by the EMA’s PRAC to recommend removing all HES IV solutions from the market, although this action comes nearly five years too late.
In 2013, the EMA’s PRAC recommended a ban on HES solutions in response to voluminous evidence of the dangers of HES, such as kidney failure, bleeding and death, only to reverse its position shortly thereafter and recommend to keep the solutions on the market for use in certain patients. This recommendation was controversial, with 14 members of the PRAC issuing a dissenting opinion that observed that the recommendation was arbitrary, not based on any good evidence and inherently unworkable. Now, in response to two studies confirming that the EMA’s restrictions on the use of HES were not being (and almost certainly could not have been) adhered to, the PRAC finally has brought its recommendations in line with the scientific evidence.
The U.S. Food and Drug Administration (FDA) must now follow suit with an immediate ban on HES solutions in the U.S. In 2013, like the EMA, the FDA opted to keep HES solutions on the market with similar restrictions as those previously adopted by the EMA. Last February, Public Citizen and two internationally recognized experts in critical care petitioned the FDA to remove HES solutions from the market. The petition subsequently was endorsed by 28 other prominent experts from around the world. But the FDA has failed to respond to the petition.
The EMA PRAC’s new recommendation unequivocally demonstrates that only a complete ban on these dangerous IV solutions will prevent further unnecessary patient deaths and injuries. For such a product, with no unique benefit because of the availability of other equally effective, but clearly less dangerous IV solutions, it would be inexcusable for the FDA not to act on our petition and immediately ban HES solutions in the U.S.