The European Medicines Agency said on Friday that current stocks of Baxter International’s peritoneal dialysis solutions should be replaced because of the possibility of contamination. The regulator was informed by Baxter of the potential presence of endotoxins in Dianeal, Extraneal and Nutrineal — three sterile solutions used in patients who have to undergo dialysis because of kidney failure.
“Although the number of batches affected is likely to be low, the agency’s Committee for Medicinal Products for Human Use has concluded that current stocks should be replaced, because it is not possible to identify which bags are affected,” the London-based watchdog said.
There is a risk that patients who receive solutions containing endotoxins may develop aseptic peritonitis.
The problem came to light after Baxter found that a number of batches at its factory in Castlebar, Ireland, contained unexpected levels of endotoxins — toxic substances from bacterial cell debris.
The problem was caused by microscopic cracks in two of the tanks used in the production process where endotoxin-producing bacteria had settled.
