FDA issues urgent warning on dialysis product

Friday, April 14th 2000, 12:00 am

By: News On 6

WASHINGTON (AP) -- The Food and Drug Administration issued an urgent warning Friday that an unapproved product being used to keep lines open in some dialysis units can be deadly if infused into patients.

The FDA said it had one report of a death in which a patient suffered cardiac arrest shortly after triCitrasol was injected full strength into a permanent blood access catheter.

The agency said rapid and excessive infusion of citrate solutions can cause fatal heart rhythm disruptions, seizures and bleeding due to loss of blood calcium.

TriCitrasol is a 46.7 percent solution of sodium citrate. The FDA said it is urging hospital pharmacies and dialysis units to use a 4 percent citrate solution of citrate.

TriCitrasol is packaged in individual 30 milliliter glass vials sold individually and in hemodialysis units, the agency said.

It is made by Cytosol Laboratories in Braintree, Mass., and distributed by Medcomp of Harleysville, Pa., which are voluntarily
recalling the product, the FDA said.

About 3,000 Medcomp kits and trays containing triCitrasol were distributed nationwide and in Canada and Puerto Rico, the FDA said.

The FDA said that because there are other uses for triCitrasol it is working with the company to see that it remains available.
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