4/30/2000 – FDA Warns of Fatal Risks Linked to TriCitrasol

WASHINGTON, Apr 19 (Reuters Health) – The US Food and
Drug Administration (FDA) is warning US hospital pharmacies
and dialysis centers of at least one case of fatal cardiac arrest
linked to the unapproved injectable drug triCitrasol.

The agency issued its warning after learning of the fatality, in
which a patient went into cardiac arrest after receiving a 46.7%
concentration of the sodium citrate anticoagulant, which was
introduced into a hemodialysis permanent blood access
catheter. The catheter was implanted into the patient
immediately prior to the incident.

Rapid or excessive infusion of triCitrasol has been blamed for a
host of serious reactions, including fatal heart rhythm disorders,
seizures or bleeding due to loss of blood calcium.

The FDA is warning against the use of the drug with blood
access catheters. The agency said that it is currently reviewing a
number of additional cases that might be associated with
triCitrasol infusion when performing hemodialysis. The drug’s
manufacturer and its distributor are collaborating on the recall
effort.

Cytosol Laboratories, of Braintree, Massachusetts, markets the
drug in individual sterile, 30 mL glass vials and in catheter “kits.”
Medcomp, of Harleysville, Pennsylvania, distributes the kits
under the trade name Ash Split Catheter II, as well as the
individual vials. Medcomp is handling the recall of only those kits
and separate vials marketed before November 1, 1999.

“We have every single [catheter] kit tracked,” a Medcomp
spokeswoman told Reuters Health, noting that recall of the kits
began on April 9, followed by recall of the separate vials on April
14. The FDA claims that about 3,000 Cytosol catheter kits are
sold nationwide, although Todd Polk, Medcomp’s head of
regulatory affairs, would not confirm those numbers to Reuters
Health. Polk declined to speculate when the recall might be
brought to a close.

As to the question of whether Medcomp knew of the Cytosol
product’s status as an unapproved drug, Polk responded,
“obviously not.” The FDA said that alternative 4% citrate solutions
remain available for use in hospital pharmacies, hemodialysis
and other medical settings. The agency said that it is working
with Cytosol on a limited access plan, as the drug is still needed
in some cases to prepare white cells for transfusion.

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