Follow-up on the Danish Medicines Agency’s announcement from December 2010 (see previous announcement in the factbox to the right).
As announced in December 2010, there is presently an increased risk that peritoneal dialysis patients could develop aseptic peritonitis (inflammation of the peritoneum). Some batches of the dialysis solutions Extraneal Viaflex®, Nutrineal Viaflex® and Dianeal, all from Baxter A/S, could be contaminated with endotoxins. Contamination occurred during the manufacturing of the dialysis solutions.
Doctors and patients should still be alert to symptoms suggestive of aseptic peritonitis (e.g. cloudy effluent seen in drain bag at the end of dialysis, abdominal pain, nausea, vomiting and possibly fever).
Doctors and patients can report cases of aseptic peritonitis
Doctors can submit an electronic report of cases of aseptic peritonitis directly to the Danish Medicines Agency (please see 'Report a side effect' in the factbox to the right).
You can also send a report to the manufacturer on a form that you will receive from the manufacturer, or you download it from http://www.baxter.dk/bivirkningsskema.html. The manufacturer will subsequently report the information to the Danish Medicines Agency.
Finally, dialysis patients can submit a report directly to the Danish Medicines Agency (please see 'Report a side effect' in the factbox to the right).
The risk of contamination with endotoxins recently came out, and so far, the Danish Medicines Agency has received one single report of aseptic peritonitis (for a patient who had used Extraneal in December 2010).
The European authorities are presently investigating what caused the contamination. Furthermore, the authorities are working on securing the availability of dialysis solutions through import from countries outside the EU. The monitoring of the safety of the use of the dialysis solutions has been intensified.
In the factbox to the right, you can see the latest announcement from the European Medicines Agency as well as the letter (in Danish only) sent from the manufacturer to doctors.
For further information, please contact Chief Medical Officer Doris I. Stenver on +45 4488 9247 or +45 2246 0979 or Chief Medical Officer Jens Heisterberg on +45 4488 9198 or +45 2546 1762.