Baxter International Inc. (NYSE:BAX) told European regulators it can’t guarantee the safety of peritoneal dialysis solutions made in Ireland, saying it will temporarily shutter the facility while it runs down the problem.
The plant in Castlebar, Ireland, makes a trio of solutions used by dialysis patients. An advisory issued to European healthcare providers in December 2010 said the products (Dianeal, Extraneal and Nutrineal) might contain endotoxins, according to the EMA.
Although only a “small number” of the solution bags are likely to be affected, meaning a low risk for patients, the agency warned physicians to be on the lookout for symptom of aseptic peritonitis (cloudy effluent after dialysis, abdominal pain, nausea, vomiting and fever). No recall was issued because there are no approved replacement products in Europe (Baxter products approved in the U.S., Canada, Turkey and Singapore will be imported on an emergency basis to supplant the Castlebar products, according to the agency).
“These will promptly replace products from Castlebar in the coming months. In the meantime, batches of PD solutions manufactured in Castlebar will have to be released to meet patients’ needs,” according to the EMA
The agency said Dec. 21 that it received word from Baxter that the company can’t promise endotoxin-free product over the short term. Baxter said it will take the plant offline while it replaces “the majority of components of the manufacturing process” to eliminate the endotoxin source, according to the EMA.
The problem prompted EMA’s Committee for Medicinal Products for Human Use and the European Commission to launch a review of the Castlebar plant’s operations. The CHMP said it will issue a report once Baxter finishes replacing the suspect equipment.