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Heparin Blood Thinner by Baxter Partially Contaminated FDA Announced

by comoms | March 6, 2008 at 02:48 am | 329 views | 1 comment

In mid Feburary, U.S. health officials announced their plan to inspect a Chinese factory which could be the source of problems with the blood thinner heparin which is linked to allergic reactions and possibly four deaths.(Now linked to more than 12)

The FDA announced that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high “bolus” doses of the drug.

Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people have died after receiving heparin, although the relationship to the drug is unclear.

The Heparin story never made it to the front pages but the news below has made the CNN front page and is more proof that our entire medical process needs a big overhaul.

(CNN) -- U.S. health officials said Wednesday they have found a contaminant in a blood-thinning drug produced by Baxter Healthcare Corp. that has been linked to more than a dozen deaths in the United States.

The scrutiny began after a spike in reports of health problems associated with heparin, a drug made by Baxter from pig intestines at plants in China and Wisconsin.

Though the cause of the problems has not been determined, 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, which made up 5 percent to 20 percent of each sample tested, "reacts like heparin in some of the conventional tests used for heparin," which explains why it was not picked up, she told reporters in a conference call.

No causal link between the contaminant and the adverse events has been established yet, Woodcock said.

She added that it was not clear whether the contaminant was added accidentally, as part of the processing or deliberately.

It also was not clear whether the contaminant was introduced in the company's plant in Wisconsin or the one in China, Woodcock said.