FDA urges more blood scrutiny as it probes possible contamination

LAURAN NEERGAARD, AP Medical Writer
Friday, February 7, 2003
©2003 Associated Press

The government is investigating whether blood quarantined because it contained mysterious white particles may have played a role in health problems suffered by half a dozen people, including one who died, after recent transfusions.

The Food and Drug Administration stressed Friday that it had no evidence yet linking the blood mystery to any harm. The person who died, for instance, was already severely ill long before receiving a transfusion, and some of the other reports included allergic reactions and infections that are fairly routine transfusion side effects.

But as a precaution, the FDA urged blood banks Friday to more closely visually inspect bags of donated blood for those mysterious white clumps as it continues to investigate just what they are and what prompted their appearance a week ago.

"For patients who need blood, the benefits of transfusion continue to outweigh the risks," stressed Dr. Jesse Goodman, the FDA's chief of biological products.

Some preliminary testing suggests at least some of the particles might just be normal blood cells or other natural components that for some reason clumped up, but no possible cause has yet been ruled out, he said.

Even if initial reports that they're just clumps of blood cells called platelets prove true, such excess clumping could be risky to certain patients because they could encourage, for example, too much blood clotting. Also, scientists would be concerned about what prompted a sudden change in blood quality as well, Goodman explained.

"We want to have blood as pure a product as possible," he said. "We are certainly hoping this is not a significant safety problem, but we are also acting as though it could be."

The mysterious contamination came to light Jan. 30, when the American Red Cross asked hospitals in Georgia and northern Florida to stop using recently collected blood because some contained white particles visible inside the bags. Eventually, additional blood was quarantined in areas stretching from Illinois and Missouri to Kentucky and Tennessee.

Government testing so far suggests the particles are not any infectious substance.

The investigation so far is focusing mostly on the bags storing the blood in question, because the initially quarantined pints had been stored in a particular type of bag made by Baxter International Inc.

But the FDA revealed Friday that in recent days it has learned of possible particles spotted in blood in other parts of the country and stored in different bags.

Friday, the FDA asked all blood banks to add an extra step to their normal safety tests: Lay each blood bag on a flat counter for 10 minutes and then see if particles are visible to the naked eye. If there are, quarantine that blood and immediately call or e-mail FDA blood officials, the agency ordered.

Platelets are normally spun out of blood into other collection sytems and given separately as needed. If these were just ordinary platelets, it wouldn't take any lab rat with an ordinary microscope more than a heartbeat to identify them.

My guess is it may be some kind of toxin or substance that is causing the platelets to cling together so tightly that they can't be spun out--if they are indeed clumps of platelets.

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