It is widely reported about the meningitis outbreak that has happened in several states of America. Contaminated Methylprednisolone Acetate injections led to fungal meningitis in over 500 persons. The contamination turned out to be tragic for 39 individuals: they died. The majority of deaths occurred in Tennessee.
It was said that contaminated steroid injections had been manufactured by the New England Compounding Center (NECC) which is based in Massachusetts. The FDA tested the pharmacy in order to define what resulted in contamination and see the situation at the NECC. It was confirmed by the FDA that the contaminated steroid injections were indeed manufactured by this company.
According to the Associated Press, the FDA claimed that it was obvious that manufacture of medicines was unsterile at the NECC. The FDA said that leaking water and uncontrolled temperature were just some problems at the compounding center. The equipment utilized for preparing of solution for injections was unsterile.
Furthermore, the FDA stated that there were some other contaminants. Certain bacterial contaminants were discovered at the NECC. Although these contaminants were not real pathogens, they were capable to result in infection too. These bacterial contaminants were found in such steroids, as Betamethasone and Triamcinolone. There were not any situations reported about contamination resulted from application of these preparations. But it was stated that these drugs were also capable to lead to contamination. However the bacterial contaminants were anywhere in the environment, they had not to be in drugs. 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 improper conditions.
The situation made it clear that new rules on compounding pharmacies should be implemented. Contamination should be avoided. Otherwise, public health is in danger in the USA.
Комментариев нет:
Отправить комментарий