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FDA Provides List of NECC Customers

No Longer Accepting Cases

October 24, 2012 — Today the U.S. Food and Drug Administration (FDA) announced a public list of customers of New England Compounding Center (NECC) who may have received contaminated products. Contaminated vials of sealed medications have been linked to NECC, a compounding pharmacy, which sold the preservative-free injection medications that have been linked to a non-contagious outbreak of fungal meningitis. More than 300 people have been sickened and two dozen have died in 17 states.

FDA is concerned that other medications from NECC may have also been contaminated. They are recommending that healthcare professionals who received contaminated products should contact people who may have been exposed. The earliest known infection was linked to lots of methylprednisolone acetate from May 21.

Patients may have been exposed if they:

  • Received an injectable medication from NECC (including opthalmic medication used in eye surgery or a cardioplegic drug used in open heart surgery)
  • The medication was sent by NECC after May 21
  • The medication was administered to a patient after May 21.

The customer list was originally posted earlier this week, but retracted after FDA was notified that there were errors on the list. It was published today with the following precaution:

“The lists were prepared based on information provided by NECC, and FDA cannot vouch for the completeness or accuracy of the lists. Products shipped by NECC may be missing from the list and facility information may be incomplete. Nevertheless, this is the best information we have available, at this time, to help inform facilities and healthcare providers of NECC products shipped to their facilities since May 21, 2012.”

Earlier this week, FDA also identified the specific type of fungus implicated in the outbreak — Exserohilum rostratum. The fungus normally grows in plant matter, is not contagious, and does not often cause illness in humans. The first case of fungal meningitis was linked to another type of fungus — Aspergillus fumigatus.

Outbreaks of fungal meningitis are rare, and this one is of unprecedented size. Health experts have limited knowledge about the incubation period for this type of outbreak. Although it has been nearly a month since all lots of all medications from NECC were recalled, illness are still being diagnosed. It is possible that this fungus has a long incubation period. Furthermore, patients who received joint infections may have a longer incubation period than patients who received epidural steroid injections in the spine, which can rapidly transmit a fungus to the brain.

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