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вторник, 12 февраля 2013 г.

NECC was tested by FDA


It is widely reported about the meningitis outbreak which has occurred in several states of America. Contaminated Methylprednisolone Acetate injections led to fungal meningitis in over 500 individuals. The contamination turned out to be tragic for 39 individuals: they died. The majority of deaths occurred in Tennessee.
It was noted that contaminated steroid injections had been produced by the New England Compounding Center (NECC) which is based in Massachusetts. The FDA tested the company in order to determine what led to contamination and see the situation at the NECC. It was confirmed by the FDA that the contaminated steroid injections were indeed produced by this compounding pharmacy.
The FDA told the Associated Press that it was evident that manufacture of products was unsterile at the NECC. The FDA noted that leaking water and uncontrolled temperature were only certain problems at the pharmacy. The equipment applied for manufacture of solution for injections was unsterile.
Furthermore, the FDA stated that there were certain other contaminants. Some bacterial contaminants were found at the pharmacy. However these contaminants were not real pathogens, they were able to result in infection too. These bacterial contaminants were found in such products, as Betamethasone and Triamcinolone. There were not any situations reported about contamination caused by application of these products. But it was underlined that these products could also result in contamination. Although the bacterial contaminants presented anywhere in the environment, they had not to be in medicines. This fact pointed at unsterile conditions at the NECC and confirmed that the Methylprednisolone Acetate injections turned out to be contaminated with fungal meningitis because they were prepared in inappropriate conditions.
The situation made it clear that new laws on compounding pharmacies should be established. Contamination should be avoided. Otherwise, public health is in danger in the USA.

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