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FDA Cites 'Adverse Events' In Patients Who Got Now-Quarantined Blood

Feb 7, 2003 | Atlanta Journal-Constitution

One death and several adverse events have been reported in patients who received transfusions using blood bags quarantined after the discovery last week of strange-looking white clumps in the blood, the U.S. Food and Drug Administration reported on its Web site today.

The patient who died was already severely ill, the FDA said in an "information alert." No information was released on who the patient is or where he or she is from.

"It is not yet clear whether the events are related to or unrelated to the possible presence of particulates," the alert said. "Adverse events in the transfusion setting can occur for many reasons, including reasons related to and unrelated to the transfusion. FDA has no indications of a heightened risk of adverse events related to transfusions at this time."

The FDA has also received reports of particles in bags made by manufacturers other than Baxter Healthcare Corp., the Illinois firm previously identified as the sole maker of the bags involved in the quarantine.

"FDA cannot rule out the possibility of similar findings with other bags," the statement said.

The agency advised any blood collection agency that detects particles in blood to quarantine the supply. It said reports show some of the particles are "consistent with platelet clumps."

The FDA, along with the federal Centers for Disease Control and Prevention and the American Red Cross, continues to investigate what the material is and where it came from. "These investigations include examination of both blood bag manufacturing and blood banking practices as well as testing of these products," the FDA said.

Some authorities expected an announcement of test findings this afternoon, though statements anticipated earlier in the week repeatedly have not occurred. The white material which has been divided into four groups, ranging from flakes to clumps to oily slicks was discovered Jan. 29. After 120 blood bags were found to contain the matter, quarantines were issued, affecting much of the blood supply in Georgia, north Florida and parts of South Carolina, Tennessee, Kentucky, Ilinois and Missouri.

Hospitals have had to cancel many elective surgeries as they reserved dwindling blood supply for emergencies, though new blood was made available this week, slightly easing the crunch.

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