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вторник, 12 февраля 2013 г.

FDA reported about additional contaminants at NECC


It is widely reported about the meningitis outbreak which has happened in certain states of America. Contaminated Methylprednisolone Acetate injections led to fungal meningitis in more than 500 individuals. The contamination turned out to be fatal for 39 persons: they died. The majority of deaths occurred in Tennessee.
It was claimed that contaminated steroid injections had been manufactured by the New England Compounding Center (NECC) that is based in Massachusetts. The FDA tested the pharmacy in order to define what led to contamination and see the situation at the NECC. It was affirmed by the FDA that the contaminated steroid injections were really produced by this compounding pharmacy.
The FDA told the Associated Press that it was obvious that preparing of medicines was unsterile at the NECC. The FDA noted that leaking water and uncontrolled temperature were just certain problems at the company. The equipment applied for manufacture of solution for injections was unsterile.
Furthermore, the FDA stated that there were some other contaminants. Several bacterial contaminants were discovered at the NECC. Although these contaminants were not real pathogens, they were able to cause infection too. These bacterial contaminants were found in such steroids, as Betamethasone and Triamcinolone. There were not any cases reported about contamination caused by usage of these preparations. But it was claimed that these medications could also cause contamination. Although the bacterial contaminants were anywhere in the environment, they had not to be in preparations. This fact pointed at unsterile conditions at the NECC and affirmed that the Methylprednisolone Acetate injections turned out to be contaminated with fungal meningitis because they were prepared in improper conditions.
The situation made it clear that new laws on compounding pharmacies should be implemented. Contamination should be avoided. Otherwise, health of Americans is in danger.

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