FDA Urges More Blood Scrutiny

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Fri Feb 7, 2003 6:01 pm

FDA Urges More Blood Scrutiny

 

 

 

 

 

 

 

FDA Urges More Blood Scrutiny

1 hour, 32 minutes ago Add Health - AP to My

 

http://story.news./news?

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By LAURAN NEERGAARD, AP Medical Writer

 

WASHINGTON - 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.

 

 

Quote Data provided by Reuters

 

 

 

The Food and Drug Administration (news - web sites) 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 (news - web sites) 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.