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четверг, 21 февраля 2013 г.

NECC violated laws earlier as well


In 2003 the FDA designed to close the New England Compounding Center (NECC) which recently caused the meningitis outbreak in several states of America. The Massachusetts pharmacy produced tainted Methylprednisolone Acetate injections. Over 400 individuals that applied the contaminated steroid injections were sickened with fungal meningitis. This disease turned out to be fatal for 39 individuals.
According to a recent report published by the House of Energy and Commerce Committee, the meningitis outbreak could have been prevented. The report revealed many cases related to the NECC that should have been shut down by the FDA earlier.
The FDA stated in 2003 that the NECC should not have produced medicines till improving of the situation. But finally the FDA didn’t prohibit manufacture of medications at the NECC. Since the NECC was claimed to be a pharmacy, it should have been monitored by Massachusetts officials. Thus, the FDA let Massachusetts colleagues to resolve the problem. As for Massachusetts officials, they didn’t prohibit manufacture of medications at once. The NECC continued to produce products. Just Barry Cadden, the owner of the pharmacy, got reprimand.
Furthermore, the NECC was guilty of some illegal actions. The company acted improperly under its license. While the NECC was a pharmacy, it acted as a manufacturer and sent thousands dosages of medicines to hospitals and individual patients.
In 2002 several persons experienced unusual negative results after they had applied bethamethasone injections produced by the NECC.
Later several persons who got methylprednisolone acetate injections produced by the NECC were sickened with bacterial meningitis. Since these individuals received full recovery because of antibiotics, the case was forgotten. The NECC was not sanctioned for the tainted preparations.
These and even several other cases manifest that the Massachusetts company should have sanctioned earlier. The pharmacy should have been closed for its illicit and improper actions. But the Compounding Center was never sentenced to any serious penalties. As a result, the company continued to produce medications which were dangerous for consumers’ health. Finally, the meningitis outbreak caused by tainted injections of the NECC spread to certain states and sickened many individuals. If the company had been shut down earlier, the contamination with deadly fungal meningitis would not have taken place.

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