Important Safety Information on Accusol 35 Haemodialysis Solutions for Acute Renal Therapy - Notice to Hospitals

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Contact: Therapeutic Products Directorate - Office of Risk Management

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NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on Accusol 35 Haemodialysis Solutions for Acute Renal Therapy

August 1, 2008

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Emergency Medicine, Pharmacy, Pediatrics, Anesthesia, Geriatrics, Internal Medicine, Nephrology, Dialysis Units, Intensive Care, and/or other Departments as required, and other involved professional staff and post this NOTICE in your institution.

Subject: Risk of precipitate formation with Accusol^TM 35 Haemodialysis solutions when used for Haemofiltration and Haemodiafiltration treatment modes.

Edwards Lifesciences in consultation with Health Canada would like to advise you that precipitate formation has been observed in ACCUSOL 35 haemodialysis solutions for acute renal therapy when these solutions are used for treatment modes other than haemodialysis.

Baxter Healthcare, Edwards Lifesciences manufacturing partner for Accusol 35, has identified a risk of precipitate formation (calcium carbonate) associated with the Accusol 35 solutions in countries where they are approved for haemofiltration and haemodiafiltration, and indicated for use as substitution solution administered via the dialysis compartment of the dialyzer or the arterial or venous blood lines. Forty-two (42) reports of visible white precipitate formation in Continuous Renal Replacement Therapy (CRRT) lines, while using Accusol 35 for haemofiltration and haemodiafiltration treatment modes, have been received from these countries. Among these 42 reports there have been a total of four cases reported to Baxter Global Pharmacovigilance as adverse events, all of which had fatal outcomes. None of these adverse events have a causal relationship with the use of Accusol 35 or precipitate formation in the solution. If present, precipitate is typically observed in either the pre-dilution or post-dilution lines after several hours of therapy. A representative photograph of precipitate is provided at the end of this posting. The risk associated with this precipitate formation when Accusol 35 is used in haemofiltration or hemodiafiltration treatment modes is related to particulate matter potentially passing through the venous system and causing small vessel obstruction in the pulmonary vascular bed or of particulate access to the systemic arterial circulation, causing arterial embolism.

No occurrences of precipitate formation have been reported for Accusol 35 solutions sold by Edwards Lifesciences Canada. This Notice to Hospitals does not impact Edwards Lifesciences product codes SOL35K0 (DIN 02294753) or SOL35K4 (DIN 02294788) when they are used according to their labeling and intended use. SOL35K0 and SOL35K4 solutions are only to be used for haemodialysis; they are not to be used for treatment modes other than haemodialysis.

Edwards Lifesciences is closely monitoring this situation, and Baxter Healthcare is conducting a thorough investigation to determine the root cause of the precipitate. Edwards Lifesciences and Baxter Healthcare will take the appropriate corrective action to ensure that the underlying source of the precipitation is properly addressed. Additional information will be provided to you when it becomes available.

Managing marketed health product related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.

Any cases of precipitate formation or other serious or unexpected adverse reactions in patients receiving Accusol 35 should be reported to Edwards Lifesciences sales representative (Alain Boulet, phone 905-566-4256), regulatory management (Steve Long, phone 905-566-4235), or communicated to Edwards Lifesciences Canada or Health Canada at the following addresses:

Sincerely,

original signed by

Brian Heyland,
Vice-President and General Manager
Edwards Lifesciences (Canada) Inc.

Figure 1. Representative photograph of precipitate.

Accusol is a trademark of Baxter International Inc.