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At least 19 deaths have been linked to the drug since 2007
On Wednesday, March 5th, 2008, U.S. health officials said they have found a contaminant in a blood-thinning drug produced by Baxter Healthcare Corp. The contaminant has been linked to more than a dozen deaths in the United States.
The actual investigation began in early February and shortly thereafter the FDA instituted a recall of some forms of the product.
What caught the eye of the FDA was an unusual spike in reports of health problems associated with heparin. Heparin is a drug made by Baxter Healthcare Corp. from pig intestines at manufacturing plants in both China and Wisconsin.
The investigation continues, but early on the FDA investigators found "a heparin-like compound -- that is not heparin -- present in some of the active pharmaceutical ingredients" in both facilities, said Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research.
The contaminant was found to be 5 to 20 percent of each and every sample tested. It reacted very similar to heparin in many conventional tests used, which explains why it was not originally discovered.
One scary thing the FDA is still trying to figure out: Was the contaminant added accidentally... perhaps as part of the processing system? Or was it added deliberately? In addition, they haven't figured out if it was introduced in the plant in Wisconsin or the one in China. On both questions, a spokeman for the FDA says, "It's not clear."
The FDA hopes to release recommendations later this week for manufacturers and regulators on how to screen for the contaminant.
Dr. Woodcock was asked if the heparin contamination could be a similar case as the contaminated pet food from China last year (manufacturers replacing ingrediants to save money/boost profits), she said "It's possible."
Dr. Andrew C. von Eschenback, FDA commissioner said that doctors have been using the blood-thinner for 60 years with "no history of any problems whatsoever", and that it's use can keep potentially deadly blood clots from forming in the veins, arteries and lungs.
Von Eschenbach said it would be "disingenuous" to expect the agency would be able to inspect "every institution in every case."
Based on that statement, it appears that individuals just "pay their money, and take their chances"... just like the hoop throw at the carnival.
Since the agency issued its report that 19 deaths had been linked to the drug since January 1, 2007, it has received additional word of another 27 deaths.
In total, the FDA has received 785 reports of adverse events linked to heparin. These include difficulty breathing, nausea, vomiting, excessive sweating and plummeting blood pressure that can lead to life-threatening shock.
"They're continuing to come in fairly rapidly because there has been a lot of reporting of this," Dr. Woodcock said.
