Iowa Update (#1) on Outbreak of Meningitis and Stroke
According to the Iowa Department
to the Iowa Department of Public Health, no cases have been reported in Iowa.
The FDA has assured the Iowa Department of Public Health (IDPH) that none of the
implicated products have been distributed in Iowa (three lots of
methylprednisolone acetate (PF) 80mg/ml). The New England Compounding
Center (NECC), is now recalling all of their products (some of which have been
distributed in Iowa). No action is needed at this time regarding these
other recalled products or patients who may have received them (other than to
cease using these products).
providers in Iowa are asked to remain vigilant for any illnesses associated with
these products and to contact IDPH with reports of illnesses, questions, or
concerns at 800-362-2736. Below is a summary of information on
this situation from the CDC:
CDC and FDA continue to work
closely with state public health departments on a
multistate investigation of
fungal meningitis among patients who received an
epidural steroid injection. Some of these patients also suffered strokes that
may have resulted from their infection. These cases are associated with a
potentially contaminated steroid medication prepared by New England Compounding
Center (NECC), located in Framingham, Mass. This HAN notice provides updated
information about the investigation (including a change in the case
definition*), laboratory findings, an expanded voluntary recall of products, and
recommendations for clinicians
CDC, in collaboration with FDA,
state public health departments, and state boards of pharmacy, has been
investigating an ongoing outbreak of meningitis associated with a potentially
contaminated steroid medication, preservative-free methylprednisolone acetate
(80mg/ml) prepared by New England Compounding Center, located in Framingham,
Mass. CDC and state public health departments are actively coordinating outreach
to patients who have been exposed to this potentially contaminated medication.
As of October 8, 2012, a total of 105 cases, including 8 deaths, have been
reported in 9 states: Florida (4 cases), Indiana (11 cases), Maryland (5 cases,
including 1 death), Michigan (21 cases, including 2 deaths), Minnesota (3
cases), North Carolina (2 cases), Ohio (1 case), Tennessee (35 cases, including
4 deaths), and Virginia (23 cases, including 1 death). Fungus has been
identified in specimens obtained from at least nine patients, one of whom also
had Propionibacterium acnes, of unclear clinical significance, isolated
from a post-mortem central nervous system specimen. In addition to an
Aspergillus spp. isolated from a Tennessee patient, the fungus
Exserohilum rostratum was identified in other patients, indicating the
possibility of infections caused by multiple organisms. Fungal meningitis is not
transmitted from person to person.
The clinical presentation of infected patients remains consistent with the prior
report: onset of symptoms is typically 1 to 4 weeks following injection with a
variety of symptoms, including fever, new or worsening headache, nausea, and new
neurological deficit (consistent with deep brain stroke). Some of these
patients’ symptoms were very mild in nature. Cerebrospinal fluid (CSF) obtained
from these patients has typically shown elevated white cell count (with a
predominance of neutrophils), low glucose, and elevated protein. As of October
8, no infections resulting from injection into a peripheral joint space have
On September 26, 2012, the NECC voluntarily recalled the following three lots of
methylprednisolone acetate (PF) 80mg/ml:
(PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
(PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
(PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013
All infections detected as of October 8 have occurred after injections with
methylprednisolone acetate products from one of these lots. At this time, there
is no evidence of infection related to other NECC products.
The FDA investigation into the NECC
facility is ongoing. On October 5,
observing “fungal contamination by direct microscopic examination of foreign
matter taken from a sealed vial of methylprednisolone acetate collected from the
New England Compounding Center.” Further analysis is ongoing. On October 6, NECC
expanded its previous recalls to include all products currently in circulation
that were compounded at and distributed from its facility in Framingham, Mass.
More information about this recall is available at the
Physicians should contact (by phone or in person) any
patient who had an injection (e.g., spinal, joint) after May 21, 2012, using any
of the following three recalled lots of preservative-free methylprednisolone
acetate (80mg/ml) produced by NECC,
to determine if they are having symptoms:
(PF) 80mg/ml Injection, Lot# 05212012@68, BUD 11/17/2012
(PF) 80mg/ml Injection, Lot#06292012@26, BUD 12/26/2012
(PF) 80mg/ml Injection, Lot# 08102012@51, BUD 2/6/2013
Symptoms that should prompt diagnostic evaluation include: fever, new or
worsening headache, neck stiffness, sensitivity to light, new weakness or
numbness, increasing pain, redness or swelling at injection site. Some of the
symptoms of patients who have ultimately been diagnosed with meningitis have
been mild and not classic for meningitis (e.g., new or worsening headache
without fever or neck stiffness).
Healthcare professionals should cease use of any product produced by
NECC, all of which have been recalled.
is currently not asking clinicians to actively
contact patients who received other products, beyond the previously listed
medications, from NECC to assess for symptoms. However,
clinicians should remain vigilant, and report to the state public health
department, any infection identified in a patient known to have received a
product from NECC.
CDC has updated clinician
Interim Instructions Diagnostic Testing and Specimen
Submission to CDC
Treatment Guidance for Central Nervous System and/or Parameningeal Infections
Associated with Injection of Potentially Contaminated Steroid Products
Role of antifungal prophylaxis in asymptomatic patients
Role for lumbar puncture in asymptomatic patients
Definition (note: the initial date for an
epidural/joint steroid injection has been revised from July 1, 2012, to May
1. A person with meningitis1 of sub-acute onset (1-4 weeks) following
epidural injection after May 21, 2012.
2. A person with basilar stroke 1-4 weeks following epidural injection after May
21, 20122, who has not received a diagnostic lumbar puncture.
3. A person with evidence of spinal osteomyelitis or epidural abscess at the
site of an epidural injection diagnosed 1-4 weeks after epidural injection after
May 21, 2012.
4. A person with septic arthritis3 diagnosed 1-4 weeks following
steroid joint injection after May 21, 2012.
diagnosed meningitis meaning one or more of the following symptoms: headache,
fever, stiff neck, or photophobia and a CSF profile consistent with
meningitis (pleocytosis +/- low glucose, elevated protein).
people, if possible, should have a lumbar puncture.
diagnosed septic arthritis meaning new or worsening pain with presence of
effusion or new or worsening effusion.
Multistate Meningitis Outbreak Investigation
Meningitis and Stroke Associated with Potentially
CDC Website on Fungal Diseases
FDA Statement on Fungal Meningitis Outbreak