19 mars, 2008 21:02
Heparin ingredient linked to 21 deaths was modified
FDA says it does not know if blood thinner component caused deaths
By Jonathan D. Rockoff
Sun reporter
12:40 PM EDT, March 19, 2008
WASHINGTON
The Food and Drug Administration said today that they've identified the contaminant in Heparin products linked to as many as 21 deaths and that it came from a chemical not approved for use in prescription drugs.
FDA officials said they still don't know whether the modified ingredient caused the deaths and more than 700 other reports of side effects, and whether it was introduced deliberately as a substitute.
The modified ingredient -- its name is oversulfated chondroitin sulfate -- looks like the main ingredient in Heparin and acts like it during routine quality testing of the drug.
But FDA officials said it's neither a natural component of the Heparin production process, which takes crushed pig intestines and then purifies them into the main ingredient, nor a common contaminant that frequently threatens purification.
"It didn't come straight from the pig. It does not appear to be a natural contaminant that got in there," Dr. Janet Woodcock, director of FDA's drug division, said in a conference call with reporters.
That's led investigators to suspect the Heparin ingredient was chemically modified to yield the contaminant. Between 2 and 50 percent of suspect Heparin supplies were found to contain the substance, Woodcock said.
Ill., recalled most of its Heparin products last month, after some were linked to hundreds of reports of serious side effects, including quickening heartbeats, nausea and dizziness.
Since the recall went into effect, the FDA hasn't received any more reports of deaths, Woodcock said.
As a precaution, the FDA is making sure that all imports of Heparin's main ingredient are inspected before distribution in the U.S. and that all Heparin products are tested for the contaminant before sale.
