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Update : Additional contamination identified in medical products from New England Compounding Center
  • Published Date:
    12/3/12
  • Source:
    HAN ; 337
  • Language:
    English
Filetype[PDF - 2.17 MB]


Details:
  • Corporate Authors:
    Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration. ;
  • Series:
  • Description:
    December 03, 2012, 4:55 ET

    CDCHAN-00337

    Summary: As part of the ongoing investigation of the multistate outbreak of fungal meningitis and other infections, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) continue to test medical products from the New England Compounding Center (NECC) in Framingham, Mass. CDC and FDA are reporting today additional microbial contamination identified in NECC products, which updates the November 1, 2012 Health Alert Network advisory. This update includes the following key points:

    • CDC and FDA have identified additional microbial contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC.

    • These include bacteria known as Bacillus, and fungal species including Aspergillus tubingensis, Aspergillus fumigatus, Cladosporium species, and Penicillium species.

    • Although rare, some of the identified Bacillus species can be human pathogens. Some of the fungal organisms identified, particularly Aspergillus fumigatus, are known to cause disease in humans. It is not known how product contamination with these organisms could affect patients clinically.

    • To date, although CDC has received reports of illness in patients who have received the medications listed in the table below, including some patients who had evidence of meningeal inflammation, CDC and public health officials have no reports of laboratory confirmed bacterial or fungal meningitis, spinal, or paraspinal infections caused by these products.

    • The available epidemiological and laboratory data do not, at this time, support evidence of an outbreak of infections linked to usage of non-methylprednisolone NECC products.

    • CDC's recommendations to healthcare providers for diagnosing and treating symptomatic patients who have received NECC products have not changed as a result of these findings.

    • CDC continues to recommend that clinicians remain alert for the possibility that infections may have resulted from injection of NECC products, and that routine laboratory and microbiologic tests, including bacterial and fungal cultures, should be obtained as deemed necessary by treating clinicians.

    • Clinicians should continue to report infections potentially related to NECC products to FDA's MedWatch and to state health departments.

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