meningitis extra cre..

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Exoserohilum rostratum
KINGDOM: Fungi
PHYLUM: Ascomycota
ORDER: Pleosporales
ECOLOGY:
• Common mold found in soil and plants, especially grasses
• Thrives in warm, humid climates
• Some species plant pathogenic, has been used for biological control of certain
grassy weeds
• Exoserohilum rarely causes infections, but include sinusitis and skin infections,
keratitis, subcutaneous phaehyphomycosis, endocarditis, osteomyelitis
• Exoserohilum infections most often occur in people with weak immune systems
and injuries
• Exoserohilum is recognized as a human pathogen, and is the cause of the fungal
meningitis outbreak of 2012
How Did This Happen?
• Beginning May 21, 2012, as many as 14,000 patients
were given spinal injections of a contaminated,
preservative free steroid, methylpredlisolone
acetate– commonly used to treat back and joint pain
• The CDC and FDA confirmed the presence of
Exoserohilum rostratum in unopened medication
vials of MPA
• The CDC laboratory confirmation further implicates
the New England Compounding Center (a
compounding pharmacy in Farmingham, Mass.) in
the ongoing outbreak that has sickened over 400
people and killed 29 (as of November 2, 2012)
• In early September, the first fungal meningitis
patients arrived in emergency rooms around the
country, and the fungus was found in the spinal fluid
of infected patients
• Late September, the fungal outbreak was confirmed
and the drug recalled from the three presumed lots
Symptoms:
• Of the people that received the injection through the spinal cord, 409
cases has been reported (11/5/12) of fungal meningitis, stroke due to
presumed fungal meningitis, or other system related infections meeting
the outbreak case definition
• People receiving the injection to a joint are not presumed to be at risk for
fungal meningitis, but 10 peripheral joint infections caused by the fungus
have been confirmed
• Meningitis affects the memebranous lining of the brain and spinal cord.
Early symptoms of final meningitis include :
– Headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or
numbness, slurred speech and pain, redness or swelling a the injection site
• Symptoms can take more than a month to appear; according to the CDC
the longest duration from the time of injection to the onset of symptoms
in this current outbreak is 42 days
• Unlike bacterial meningitis, fungal meningitis Is not contagious. Only
people who received injections are though to be at risk
CASE DEFINITIONS:
PROBABLE CASE:
A person who received the preservative free MPA injection that definitely or
most likely came from the New England Compounding Center and
subsequently developed any of the following:
• Meningitis of unknown etiology following injection after May 21, 2012
• Posterior circulation stroke without other implicating sources following
injection after May 21, 2012
• Osteomyelitis, abscess or other infection near site of infection following
injection after 5/21
• Osteomyelitis or worsening inflammatory athritis of peripheral joint
following joiunt injection after 5/21
CONFIRMED CASE:
• A probable case with evidence (by culture, histopathology or molecular
assay) of a fungal pathogen associated with the clinical syndrome
-Center for Disease Control
Treatment:
• Fungal meningitis is treated with long courses
of high dose antifungal medication given
intravenously
• The length of treatment depends on the
status of the immune system
• Treatment is often longer for people with
immune systems not functioning well due to
conditions like AIDS, diabetes and cancer
THE DAMAGE:
BREAKDOWN BY STATE:
State
Case Count
Joint Infection
Deaths
Florida
23
0
3
Georgia
1
0
0
Idaho
1
0
0
Illinios
2
0
0
Inidana
51
0
3
Maryland
23
0
1
Michigan
119
6
7
Minnesota
10
0
0
New Hampshire 12
4
0
New Jersey
24
0
0
New York
1
0
0
North Caroline
3
0
1
Ohio
16
0
0
Pennsylvania
1
0
0
State
Case Counts
Joint
Infection
Deaths
Rhode Island
2
0
0
South
Caroline
1
0
0
Tennessee
78
0
13
Texas
2
0
0
Virginia
49
0
2
TOTALS
419
10
30
• These numbers continue to rise, as of Novermber 9th, 19
states have confirmed cases with 438 cause counts and
32 deaths
FDA FORM ‘483’:
• The FDA issues a 483 at the end of an inspection when the investigators believe
they they observed conditions or practices that indicate violations of the FDA
• What did the FDA find at the New England Compounding Center?
• 321 vials of MPA contained a “greenish-black foreign matter”
• 17 other vials from the same bin contained “white filamentous growth”
• 50 of the vials were sent and tested at the FDA lab and all were confirmed to
have presence of microbial growth
• The investigation notes the use of non-sterile active active ingredients
• Condensation and discoloration were found on the autoclave used to sterilize
the injections
• FDA observed different colored residues lining different weigh station hoods
• The report details “problems with the NECC’s ability to maintain clean room”
• Bacteria and mold were found on multiple surfaces of the clean room
• Air conditioning was turned off from 8 pm to 530 am nightly—not a
typical practice of a clean room
• These observations are merely a glimpse of the full report, which was released and
is accessible to the public on the FDA’s website
• Form 483 for NECC
What Now?
• The investigation is not final, and is still underway
• Ameridose, another pharmaceutical company linked to
the NECC voluntarily recalled all of its products
following the outbreak and investigation
• Another Massachusetts compounding pharmacy,
Resource Infusion, was recently shut down due to
sterility concerns following a surprise inspection
• Director of the Mass. Pharmacy board along with the
Mass. Department of Public Health’s interim
commissioner were both terminated after officials
uncovered a complaint against the NECC by Colorado
pharmacy regulators just months before the outbreak
Works Sited
“Multistate outbreak of fungal meningitis and other
infections”. FDA. 13 Nov 2012.< http://www.fda.gov/
Drugs/DrugSafety/FungalMeningitis/default.htm>
“Multistate Fungal Meningitis Outbreak Investigation”.
Center for Disease Control and Prevention. 9 Nov
2012. <http://www.cdc.gov/hai/outbreaks/
meningitis.html>
Haelewater, Dannny. “Exoserohilum rostratum, the killing
fungus”. Scilogs. 24 Oct 2012. <http://
www.scilogs.com/life_off_the_edge/exserohilumrostratum-the-killing-fungus/>
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