Friday, November 02, 2012

CDC HAN Advisory: Additional NECC Products Found Contaminated

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Last night the CDC – as part of their investigation into the multistate fungal meningitis outbreak linked to contaminated steroid products distributed by the New England Compounding Center (NECC) -  issued a pair of HAN Advisories. 

 

  • The first, is a notification that two additional products produced by NECC (betamethasone and cardioplegia solution) have tested positive for bacterial contamination.  
  • The second advisory is essentially a HAN version of the FDA’s announcement on Wednesday of a total recall of all Ameridose products.  Ameridose is a a sister company to NECC.

 

The CDC’s Health Alert Network (HAN) is designed to ensure that communities, agencies, health care professionals, and the general public are able to receive timely information on important public health issues.

 

You can sign up for HAN messages, and scores of other CDC and HHS email notifications, by going to the CDC - Quick Subscribe GovDelivery page

 

There are 4 types of HAN releases, starting from the highest priority to the lowest.

 

  • Health Alert - Conveys the highest level of importance; warrants immediate action or attention.
  • Health Advisory - Provides important information for a specific incident or situation; may not require immediate action.
  • Health Update - Provides updated information regarding an incident or situation; unlikely to require immediate action.
  • Info Service -Provides general information that is not necessarily considered to be of an emergent nature.

 

Yesterday, the CDC also updated the number of confirmed infections due to these contaminated pharmaceuticals, which now total 377 cases of fungal meningitis, and 9 peripheral joint infections.

 

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The following are excerpts from last night’s HAN Advisory on NECC contamination issues.

 

Contamination Identified in Additional Medical Products from New England Compounding Center

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.

NECC is the firm that distributed and recalled injectable steroid medications implicated in the current outbreak of fungal meningitis and other infections. CDC and FDA are reporting today that product testing has identified bacterial contamination with several Bacillus species and closely related bacterial organisms in unopened vials of betamethasone and cardioplegia solution that were distributed and later recalled by NECC on October 6, 2012. These bacteria are commonly found in the environment and have been rarely reported as a cause of human disease; it is not known how product contamination with these species might affect patients.

Although clinical infection is possible, CDC has not received reports of laboratory-confirmed cases of infection due to Bacillus or closely related organisms linked to these 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. Additional microbial organisms may be identified in recalled NECC products as additional laboratory testing is completed.

<SNIP>

As part of the ongoing investigation, FDA and CDC have been testing various NECC products for evidence of contamination. Laboratory testing at CDC and FDA has found multiple species of Bacillus and closely related bacterial organisms in unopened vials of betamethasone and cardioplegia solution, as shown in the table below.

Medication
Lot number
Microbial contamination

Betamethasone
08202012@141
Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp.

Betamethasone
07032012@22
Bacillus niabensis, Bacillus circulans

Betamethasone
07302012@52
Bacillus lentus, Bacillus circulans

Cardioplegia solution
09242012@55
Bacillus halmapalus, Brevibacillus choshinensis

Other cultures for these products, including fungal cultures, are pending.

Recommendations to Healthcare Providers
CDC and FDA have previously advised that healthcare professionals should cease use of any product produced by NECC. On October 15, FDA issued a MedWatch Safety Alert advising clinicians to follow-up with patients who received any injectable NECC product, including betamethasone or cardioplegia solution purchased from or distributed by NECC after May 21, 2012. Clinicians were also requested to report any suspected adverse events following use of these products to
FDA's MedWatch program.

 

CDC continues to investigate reports of potential infections in patients receiving other NECC products. As of November 1, CDC has received no reports of confirmed infections resulting from injection of any NECC product except those from the three recalled lots of preservative-free methylprednisolone acetate.[1]

 

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 routine laboratory and microbiologic tests, including bacterial and fungal cultures, deemed necessary by treating clinicians.

 

These bacteria have been rarely reported as a cause of human disease. Nevertheless, clinicians should consider these product findings when reviewing laboratory results from patients who have been exposed to a NECC product, since Bacillus and related bacteria are often considered in clinical results to be possible skin contaminants. Physicians should continue to report infections potentially related to NECC products to FDA’s MedWatch and to state health departments.


1. NECC lots of methylprednisolone acetate (PF) 80mg/ml:

  • Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
  • Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
  • Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013

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