Atlanta, GA – Centers for Disease Control and Prevention’s laboratory-confirmed results found on this page are from three New England Compounding Center (NECC) preservative-free methylprednisolone acetate (MPA) lots recalled on September 26th, 2012.
CDC’s Fungus Reference Laboratory has the capacity and technology to examine fungal isolates under the microscope and to confirm their identification using DNA sequencing methods.
CDC and the states are testing tissue and fluid samples from patients with probable or confirmed fungal infection. CDC scientists are looking to see if the samples contain fungi and other microbial pathogens, and if so, what type.
In addition, FDA and CDC are testing vials of NECC preservative-free MPA to see if they contain fungi and other microbial pathogens and if so, what type.
CDC Laboratory Results
As of October 22nd, 2012, Exserohilum rostratum has been found in clinical specimens for all but two of the 54 patients with CDC laboratory-confirmed fungal meningitis who meet the confirmed case definition.
Tests at CDC and FDA laboratories on the preservative-free MPA vials have confirmed the presence of the same fungus, Exserohilum rostratum, in unopened vials from two of the three recalled lots. Testing on the third lot of preservative-free MPA is ongoing. These laboratory test results strengthen the link between preservative-free MPA vials and the outbreak.
The fungi found in both patients and in recalled vials are common in the environment but were not recognized as a cause of meningitis before this outbreak.
Human Tissue and Fluid Samples
Date updated: October 22nd, 2012
Table 1. CDC Laboratory-Confirmed Cases of Human Infection
| CDC Laboratory-Confirmed Cases of Human Infection Associated with Recalled Lots of Preservative-Free MPA |
||
|---|---|---|
| Exserohilum rostratum |
Aspergillus fumigatus (3) | Cladosporium |
| 52 | 1 | 1 |
These numbers do not reflect all cases of fungal meningitis or joint infections because laboratory methods used to detect fungus are not highly sensitive. Many patients with potential fungal infections will have a negative laboratory result (2, 4).
Product Samples: Three Lots of Preservative-Free MPA
Date updated: October 22nd, 2012
CDC and FDA laboratories are in close communication about identifying the organisms in unopened preservative-free MPA vials.
- As of October 22nd, CDC laboratories have confirmed the presence of Exserohilum rostratum in lots #08102012@51 BUD 2/6/2013 and #06292012@26 BUD 12/26/2012. This fungus is the same genus and species as the one found in laboratory-confirmed cases of human infection.
- CDC also identified non-human pathogens Rhodotorula laryngis and Rhizopus stolonifer in lot #08102012@51, BUD 2/6/2013; and Rhodotorula laryngisin lot #06292012@26, BUD 12/26/2012.
- The fungi Rhodotorula laryngis and Rhizopus stolonifer are not known to cause disease in humans; they cannot grow at human body temperature.
Table 2. CDC Laboratory-Confirmed Organisms From Product Samples
| CDC Laboratory-Confirmed Organisms From Product Samples Associated with Recalled Lots of Preservative-Free MPA |
||
|---|---|---|
| Product(s) | Fungi Isolated | Description |
| MPA (PF) Lot #06292012@26 Beyond Use Date 12/26/2012MPA (PF) Lot #08102012@51 Beyond Use Date 2/6/2013 |
Exserohilum rostratum | Known to cause human disease |
| MPA (PF) Lot #06292012@26 Beyond Use Date 12/26/2012MPA (PF) Lot #08102012@51 Beyond Use Date 2/6/2013 |
Rhodotorula laryngis | Not known to cause human disease |
| MPA (PF) Lot #08102012@51 Beyond Use Date 2/6/2013 |
Rhizopus stolonifer | Not known to cause human disease |
At A Glance
- Status: Ongoing Investigation
- Infection: Fungal
- Facility Type: Outpatient Setting
- Case Count: 377
- States: 19
- Deaths: 28*
*Virginia is now reporting 2 deaths, instead of 3 deaths. - Last case update: October 31st, 4:00pm
Table By State
| State | Total Case Counts | Peripheral Joint Infections | Deaths |
|---|---|---|---|
| TOTALS | 377* | 9 | 28 |
| Florida (FL) | 23 | 0 | 3 |
| Georgia (GA) | 1 | 0 | 0 |
| Idaho (ID) | 1 | 0 | 0 |
| Illinois (IL) | 1 | 0 | 0 |
| Indiana (IN) | 48 | 0 | 3 |
| Maryland (MD) | 22 | 0 | 1 |
| Michigan (MI) | 101 | 6 | 7 |
| Minnesota (MN) | 10 | 0 | 0 |
| New Hampshire (NH) | 11 | 3 | 0 |
| New Jersey (NJ) | 18 | 0 | 0 |
| New York (NY) | 1 | 0 | 0 |
| North Carolina (NC) | 3 | 0 | 1 |
| Ohio (OH) | 14 | 0 | 0 |
| Pennsylvania (PA) | 1 | 0 | 0 |
| Rhode Island (RI) | 1 | 0 | 0 |
| South Carolina (SC) | 1 | 0 | 0 |
| Tennessee (TN) | 74 | 0 | 11 |
| Texas (TX) | 1 | 0 | 0 |
| Virginia (VA) | 45 | 0 | 2** |
*368 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 9 peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections.
**Virginia is now reporting 2 deaths, instead of 3 deaths.
Case counts by state are based on the state where the procedure was performed, not the state of residence.
About the Investigation
- CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from two of the three implicated lots from NECC (Lot #06292012@26, BUD12/26/2012 and Lot #08102012@51, BUD 2/6/2013). The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections. Testing on the third implicated lot of methylprednisolone acetate and other NECC injectable medications continues.
- As of October 22nd, 2012, a total of 54 patients have CDC laboratory-confirmed fungal meningitis. This form of fungal meningitis is not contagious. CDC’s laboratory has confirmed Exserohilum rostratum in clinical specimens for all but two patients of these patients. Of the other two patients, one has been found to be infected with Aspergillus fumigatus and one with Cladosporium. These fungi are common in the environment but were not a recognized cause of meningitis prior to this outbreak.
- CDC continues to work with states to determine if there may be other fungal infections caused by exposure to NECC products beyond the three lots of preservative-free methylprednisolone acetate (80mg/ml) from NECC that were recalled on September 26, 2012. CDC does not have firm evidence that fungal infections have been caused by exposure to other NECC products.
- CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from the three implicated lots of methylprednisolone and nearly 97% have now been contacted for further follow-up.
- Patients and clinicians need to remain vigilant for onset of symptoms because fungal infections can be slow to develop. In this outbreak symptoms typically have appeared 1 to 4 weeks following injection, but it’s important to know that longer and shorter periods of time between injection and onset of symptoms have been reported. Therefore, patients and physicians need to closely watch for symptoms for at least several months following the injection. See updated Patient Guidance for more information, and contact your physician if you are concerned you may have become ill from your injection.
- Information about the investigation and guidance for clinicians, including interim treatment guidelines, is available at http://www.cdc.gov/hai/outbreaks/meningitis.html. CDC recommendations are subject to change as more information becomes available.
