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четверг, 21 февраля 2013 г.

It would be better, if NECC would have been closed in 2003


In 2003 the FDA planned to close the New England Compounding Center (NECC) that lately caused the meningitis outbreak in several states of America. The NECC manufactured contaminated Methylprednisolone Acetate injections. More than 400 individuals who used the tainted steroid injections got fungal meningitis. This disease turned out to be fatal for 39 persons.
According to a recent report written by the House of Energy and Commerce Committee, the meningitis outbreak could have been prevented. The report presented many cases linked with the NECC that should have been shut down by the FDA earlier.
The FDA stated in 2003 that the NECC should not have produced drugs till improving of the situation. But finally the FDA didn’t prohibit manufacture of medicines at the NECC. Since the NECC was claimed to be a pharmacy, it should have been ruled by Massachusetts officials. Thus, the FDA let Massachusetts colleagues to improve the situation. As for Massachusetts officials, they didn’t prohibit manufacture of medications at once. The company continued to manufacture drugs. Just Barry Cadden, the owner of the pharmacy, received reprimand.
Furthermore, the Massachusetts pharmacy was accused of certain illegal operations. The company acted inappropriately under its license. Being a pharmacy, the NECC acted as a manufacturer and sent thousands doses of preparations to hospitals and individual patients.
In 2002 certain individuals got unusual adverse results after they had administered bethamethasone injections manufactured by the Massachusetts pharmacy.
Later several individuals that got methylprednisolone acetate injections produced by the Massachusetts pharmacy were sickened with bacterial meningitis. Since these persons received complete recovery because of treatment with antibiotics, the case was forgotten. The NECC was not sanctioned for the tainted medicines.
These and even several other cases display that the Massachusetts company should have punished earlier. The pharmacy should have been shut down for its illicit and inappropriate operations. But the Compounding Center was never sentenced to any severe penalties. As a result, the company continued to produce preparations which were dangerous for consumers’ health. Ultimately, the meningitis outbreak caused by tainted injections of the Massachusetts pharmacy spread to certain states and sickened many individuals. If the pharmacy had been closed earlier, the contamination with deadly fungal meningitis would not have taken place.

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