Dianeal, Extraneal, and Nutrineal peritoneal dialysis solutions
- Medicines and Healthcare products Regulatory Agency
- 10 February 2011
- Therapeutic area:
- Urology and nephrology
Risk of aseptic peritonitis with Dianeal, Extraneal, and Nutrineal peritoneal dialysis solutions due to possible presence of endotoxin.
Article date: February 2011
In December 2010 the potential for raised endotoxin levels was identified in Dianeal, Extraneal, and Nutrineal peritoneal dialysis (PD) solutions manufactured by Baxter. If endotoxin is present there is an increased risk of aseptic peritonitis.
Available evidence suggests that only a small proportion of these PD solutions (manufactured in Castlebar, Ireland) currently marketed are likely to be affected. However, it is not possible to identify affected bags, and all potentially affected products will be recalled and replaced once there is sufficient supply of new unaffected PD solutions for patients. In the meantime replacement Dianeal, Extraneal, and Nutrineal are temporarily being imported from countries outside the EU (from Canada, USA, Singapore, and Turkey) with patient instructions for use.
Advice for healthcare professionals:
- prioritise new unaffected PD solutions (imported products) over the solutions produced in Ireland, especially for vulnerable patients who critically depend on PD solutions, including those receiving Extraneal with otherwise uncontrollable fluid overload, those with cardiac insufficiency, and those with diabetes that is difficult to control
- consider other treatment options for other patients (see letter for healthcare professionals)
- start new patients who require PD on products known to be unaffected (non-Baxter products or imported Baxter products)
- be alert to symptoms of aseptic peritonitis: cloudy effluent indicating an increased white-cell count, abdominal pain, nausea, vomiting, fever, and negative microbiological culture
- report any suspected adverse reactions with all PD solutions to Baxter immediately using the adverse-event reporting form (a copy of which is available here), specifying the batch number of product used. Your reports are critically important to the rapid identification of affected batches
Article citation: Drug Safety Update Feb 2011, vol 4 issue 7: S1.
Published: 10 February 2011
Therapeutic area: Urology and nephrology