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 over 500 patients. The contamination turned out to be fatal for 39 patients: 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) that is based in Massachusetts. The FDA tested the company 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 indeed produced by this compounding pharmacy.
According to the Associated Press, the FDA reported that it was evident that manufacture of drugs was unsterile at the NECC. The FDA said that leaking water and uncontrolled temperature were only certain problems at the pharmacy. The equipment used for preparing of solution for injections was unsterile.
Moreover, the FDA stated that there were some other contaminants. Some bacterial contaminants were found at the compounding center. However these contaminants were not real pathogens, they were capable to cause infection too. These bacterial contaminants were found in such drugs, as Betamethasone and Triamcinolone. There were not any cases reported about contamination resulted from application of these preparations. But it was noticed that these drugs could also cause contamination. However the bacterial contaminants presented anywhere in the environment, they had not to be in drugs. This fact pointed at unsterile conditions at the compounding center and affirmed that the Methylprednisolone Acetate injections turned out to be contaminated with fungal meningitis because they were manufactured in improper conditions.
The situation made it clear that new rules on compounding pharmacies should be established. Contamination should be prevented. Otherwise, public health is in danger in the USA.
Комментариев нет:
Отправить комментарий