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Baxter says premix heparin not related to adverse trial events
Baxter’s premix heparin investigation is not related to the adverse events suffered by three patients at the test site, it has been confirmed.
The company is conducting research into the product and worked with Beebe Medical Centre and industry authorities to determine the cause of three cases of intracranial bleeding.
After assessment and evaluation, it was stated that these were isolated and unfortunate cases specific to the institution and not the premix heparin.
“Our thoughts are with the patients and families involved in these tragic events,” remarked Camille Farhat, general manager of Baxter Pharmaceuticals & Technologies.
She added that the investigation included various analytical and forensic tests to verify the integrity of the product and to check contaminants were not present.
The supply chain and samples were found to be within specifications and in accordance with all requirements.
According to a statement issued by Baxter last week, the company is currently working on a vaccine for A/H1N1 influenza.
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