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Page: << Prev | 1 | 2 | 3 | Next >> Since the end of December, there have been 448 reports of adverse reactions associated with Baxter's heparin product. This compares with less than 100 reports of adverse reactions in all of 2007.
There have also been reports of 21 deaths, four of which were linked with an adverse reaction to heparin, according to the FDA.
Most of the reactions have taken place at hemodialysis centers, almost exclusively involving patients receiving a "bolus dose," which is a high dose administered over a short period of time, according to the FDA. The drug is also given to patients undergoing heart surgery.
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Adverse reactions included difficulty breathing, nausea or vomiting, excessive sweating and falling blood pressure, which can lead to life-threatening shock. These reactions have been seen with as few as several thousand units per milliliter of heparin, and as much as 50,000 units per milliliter.
So far, the source of the problems with heparin has not been identified, Kweder said, adding the investigation is continuing.
The FDA investigation has included a Baxter plant in the United States, as well as a supplier of unrefined heparin to Baxter, Changzhou SPL in Changzhou City, China. The Chinese plant is largely owned by Scientific Protein Labs in Waunakee, Wisc., which is Baxter's main supplier of heparin.
"Our inspection team has finished the inspection of the Chinese facility," Michael Rogers, director of the FDA's Division of Field Investigations in the Office of Regulatory Affairs, said during the teleconference. "The inspection revealed that the facility is currently not manufacturing heparin at this time."
Rogers said the inspection team found "a number of potentially objectionable conditions related to the firm's manufacturing process."
"The inspection team's observations relate to deficiencies in the plant's evaluation of the steps it takes to remove impurities and its investigation of out-of-specification results. Issues related to waste material flow and deficiencies related to equipment," Rogers said.
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