WASHINGTON (Reuters Health) -The US Food and Drug Administration (FDA) confirmed on Thursday that it is investigating a number of deaths recently linked to dialyzers made by Baxter Healthcare Corporation of Deerfield, Illinois.
The agency said it is working closely with Baxter as well as with foreign regulatory authorities to pinpoint what went wrong and recall the dialyzers.
Baxter began a voluntary recall in mid-October after the dialyzers were linked to over 50 deaths worldwide, including 4 in the US. The US deaths occurred at dialysis facilities in Austin, Texas and Kearney, Nebraska.
The FDA said the patients experienced shortness of breath, chest tightness, cardiac arrest and stroke symptoms within hours of being treated. The agency added that preliminary tests have led Baxter to conclude that a perfluorohydrocarbon-based fluid used in the manufacturing process may have played a role in the deaths and that confirmatory tests are underway.
Baxter has ceased manufacturing the dialyzers.
The dialyzers in question were produced between January 1998 and October 15, 2001. The first deaths to be reported occurred in Spain around mid-August. Deaths have since been reported in Croatia, Italy, Germany, Taiwan and Colombia.
Spanish health authorities said on Thursday that they have now conclusively linked the deaths in that country to the Baxter dialyzers. (see Reuters Health report, November 8, 2001.) This announcement followed an earlier statement this week that Spanish authorities are may file a lawsuit against Baxter alleging that the firm concealed information regarding the dialyzers.
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