U.S.
health officials have identified the mysterious substance, which contaminated some
batches of the blood thinner heparin associated with 19 deaths and are trying
to determine how the chemical got into the drug.
The substance is a man-made chemical compound known as
over-sulfated chondroitin sulfate which is much cheaper than heparin. Chondroitin
sulfate is a natural compound that occurs widely and is used as a dietary
supplement but the over-sulfated version has not been widely studied.
“Right now, people should not be alarmed. We have not
received any more reports of fatalities of this type since the recall on Feb.
28. We cannot rule in or out whether this was accidentally or deliberately
introduced into the product. We are investigating how it got in,” said Dr. Janet
Woodcock, head of the Food and Drug Administration’s Center for Drug Evaluation
and Research, the Associated Press reported.
Chondroitin sulfate mimics heparin, so preliminary testing
did not identify it, Woodcock said. Oversulfated chondroitin sulfate would be
less expensive to make than heparin, but FDA officials said they could not
estimate the cost difference.
However, “it is unacceptable that Americans have died and
been seriously injured by what appears to be deliberate tampering. Whether this
contaminant was introduced intentionally or by accident, the full force of the
law must be brought to bear to bring those responsible to justice. To guard
against future abuses, every drug manufacturer needs to inform FDA of where it
sources its ingredients and what it is doing to ensure that these ingredients
are pure and potent,” Sen. Edward M. Kennedy (D-Mass.), who chairs a panel that
oversees the FDA, said in a statement, according to the AP.
Woodcock said further tests would be made in order to
determine “whether or not oversulfated chondroitin sulfate, when combined with
heparin, can produce the serious allergic reactions of the sort reported to
Baxter and FDA.”
Heparin, made from ingredients extracted from pig
intestines, is used to prevent blood clots in millions of people with heart
conditions, kidney disease and in surgery. The contaminant made up between 2
and 50 percent of the heparin samples tested by the FDA, which did not assert
directly that the heparin was counterfeit on purpose.
Since the end of December, there have been 785 reports of
allergic reactions associated with Baxter’s heparin. This compares with fewer
than 100 reports of adverse reactions in all of 2007. According to the FDA,
there also have been 46 deaths among heparin users.
Following these announcements, Baxter recalled all of its heparin
products. The other major heparin supplier, APP Pharmaceuticals Inc., ramped up
production to avoid a drug shortage after the Baxter recall. Tests on APP’s
heparin have not turned up any contamination.