Bacterial Contamination Confirmed in Two Additional Injectables

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Recent testing by the FDA on steroid medications produced by the New England Compounding Center (NECC) has found more contaminants in the steroids Triamcinolone Acetonide and Betamethasone Acetate. The FDA has updated its list of contaminated drugs produced by NECC.

The initial outbreak of fungal meningitis from early October has sickened a total of 490 people, with 34 deaths. This outbreak was linked to preservative-free methylprednisolone acetate administered in epidurals or joint injections as a treatment for pain.

The other two steroid injectables, Betamethasone or Triamcinolone, have not been identified with the fungal meningitis outbreak infections. The contaminants discovered in these products are not recognized pathogens, but naturally present in the environment.

Inspections of the NECC by the FDA and Massachusetts Board of Pharmacy found several possible sources for the contamination, including leaking water, uncontrolled temperature and dirty conditions (eg, residue on equipment, puddles on the floor). These results and the finding of fungal reinforce the FDA's concern about the lack of sterility in products produced at NECC's compounding facility.

For more information call (855) 543-DRUG or visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm?source=govdelivery.

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