Baxter shuts down production line due to contamination

The Irish Times - Thursday, January 27, 2011

A CONTAMINATED production line has forced a major healthcare firm in Castlebar, Co Mayo, to temporarily shed 150 workers – up to a 10th of its workforce – for a four-month period.

The shutdown at Baxter Healthcare, where a number of kidney dialysis products have been contaminated, will take effect from Monday next.

Baxter, which has more than 1,000 on its payroll and is the largest employer in Co Mayo is US-owned. Last November the company let 200 workers go because of the downturn.

An investigation is under way into the causes of the contamination in some kidney dialysis products.

The problem centres on the presence of endotoxins in peritoneal dialysis solutions that would be used by about 230 patients in the Republic and many more across Europe to treat kidney failure.

Endotoxins are harmful substances or toxins released from bacteria after they have died.

The European Medicines Agency, which was informed of the problem in December, said the products could not be taken off the market as no alternatives were available for patients. However, in the next few weeks it is hoped Baxter will be able to provide patients with “these life-saving treatments” from alternative manufacturing plants in the US, Canada, Turkey and  Singapore, the agency said.

It explained there was a risk that patients who received peritoneal dialysis solutions which contained endotoxins might develop aseptic peritonitis, an inflammation of the peritoneum that affects the way it filters blood. Symptoms would include abdominal pain, nausea, vomiting and sometimes fever. This could force the patient to stop dialysis for a time, which could have repercussions.

However the agency says the number of peritoneal dialysis bags affected is likely to be “very small and the overall risk to patients remains low”.

Its understood that there have been very few reports of adverse reactions to the product in the Republic.

The Health Service Executive said when it was informed of this matter by the Irish Medicines Board it communicated it to the 10 dialysis units providing the treatment to adults and children. This alerted healthcare professionals to look out for possible adverse reactions to the product.

Baxter, despite initial efforts to eradicate the problem by closing down two tanks with microscopic cracks at its Castlebar plant, has now told the medicines agency it cannot guarantee the production of endotoxin-free solutions in the short term. Even after closing the tanks, endotoxins were detected in new batches. Equipment at the plant is now to be replaced.

The implications for workers of the shutdown of the production line were discussed yesterday at a meeting between them and their Siptu trade union representatives.

Patients with concerns are advised to contact their doctor.