Script: Ben Park, Meningitis
On September 21th CDC was notified by the Tennessee Department of Health of a patient with the onset
of meningitis approximately nineteen days following epidural steroid injection at a Tennessee ambulatory
surgical center. All initial cultures of cerebrospinal fluid and blood were negative for any potential
infection. Subsequently, the patient had a fungus isolated from cerebrospinal fluid by fungal culture. On
September 28th investigators identified a case outside of Tennessee, possibly indicating contamination of
a widely-distributed medication.
To date, a total of 35 cases in six states have been identified with a clinical picture consistent with fungal
infection. Tragically, at least 5 deaths have been reported. Fungus has been identified in specimens
obtained from a total of 5 patients thus far. While investigation into the exact source of these infections is
ongoing, all infected patients received preservative-free methylprednisolone acetate from among the 3
lots voluntarily recalled by the New England Compounding Center in Framingham, Massachusetts on
September 25th.
I would now like to read to you the names of the 23 states that have received medication from the New
England Compounding Center. They include:
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California
Connecticut
Florida
Georgia
Idaho
Illinois
Indiana
Maryland
Michigan
Minnesota
North Carolina
New Hampshire
New Jersey
Nevada
New York
Iowa
Pennsylvania
Rhode Island
South Carolina
Tennessee
Virginia
Texas
West Virginia
Infected patients have presented approximately one to four weeks following their injection with a variety of
symptoms including: fever, new or worsening headache, nausea, and/or new symptoms consistent with a
stroke. Some of these patients’ symptoms were very mild in nature. Cerebrospinal fluid obtained from
these patients has shown findings consistent with meningitis.
CDC and FDA are working closely with state health departments on this challenging investigation. Out of
an abundance of caution, CDC and FDA recommend that all healthcare personnel cease use and
remove from their pharmacy inventories any product produced by the New England Compounding
Center.
CDC also recommends that clinicians contact all patients who received injections using product from any
of the 3 recalled lots to determine if they have having symptoms. Patients may be experiencing mild
symptoms not typical of meningitis (such as new or worsening headache without fever or neck stiffness).
If patients are having new or worsening symptoms, even mild symptoms, they should be referred for
evaluation immediately.
While CDC is only aware of infections occurring in patients who have received epidural steroid injections,
patients who received other types of injection with methylprednisolone acetate from those three lots
should also be contacted to assess for signs of infection (such as swelling, increasing pain, redness,
warmth at the injection site) and should be encouraged to seek evaluation if such symptoms exist.
This is an ongoing investigation. Unfortunately, despite the current recall, we expect to see additional
cases as this investigation unfolds. However, it is possible that if patients are identified soon and put on
appropriate therapy, some of the unfortunate consequences can be averted. CDC will be updating you
as more information is becomes available.
Now, I would like to turn it over to my colleague Dr. Ilisa Bernstein at FDA, who will discuss the recall and
investigation at this facility.
Questions:
General:
1. What is causing these infections?
Extensive evaluation of these patients is ongoing. However, fungus has been identified from at
least 5 patients. In one of these patients, the fungus was identified as Aspergillus. Identification
of the other fungi is ongoing.
In one patient, a common skin bacterium named Propionibacterium acnes was identified. We
are currently investigating the clinical significance of this bacterium. Because we don’t yet know
if there are multiple fungi or even bacteria associated with this outbreak, it is important for
clinicians to remember to treat these patients with broad coverage.
2. Are patients who did not receive an injection at risk?
This type of meningitis is not transmitted from person to person.
3. How many patients were potentially exposed to this contaminated product? (FDA?)
X vials were produced in these 3 lots and distributed to 75? facilities in 23 states. We are not
yet sure how much of the product was actually used.
4. Will all of the patients who were potentially exposed become infected?
Investigation is ongoing.
5. What is the expected mortality?
The investigation is ongoing.
6. Are you certain the steroid is the source of the infection?
Investigation is ongoing. However we know all patients were exposed to the recalled steroid.
Guidance for clinicians and patients:
1. What should clinicians be doing?
Immediately cease use and remove from pharmacy inventories any product produced by the
New England Compounding Center until investigation by the FDA and the Massachusetts Board
of Pharmacy has been completed.
Contact any patient who received an injection with methylprednisolone acetate that was
recalled on September 25 to determine if they are having new symptoms and if, present, get
them referred for urgent evaluation.
2. Is there a way for patients to know if they received medication from these 3 lots or the
compounding pharmacy?
If patients are concerned about which product was used in their procedure, they should contact
the physician who performed their procedure.
3. What symptoms should prompt patients to seek care?
For patients who got recalled lot
The facilities who received a recalled lot are actively contacting patients to let them know they
received medication from one of these lots, and to check on patients symptoms.
For patients who received a spinal injection containing medication from one of these recalled
lots, concerning symptoms would include: fever, new symptoms of headache or worsening
headache, new stiff neck or sensitivity to light, or symptoms suggestive of a new stroke such as
slurred speech, new or worse difficulty walking, or increased dizziness or falls. Patients should
also seek care if they have worsening pain, redness or swelling at their injection site.
For patients who got spinal but don’t know if they got a recalled lot
If patients are concerned, they should contact their physician to find out if they received a
medication from one of these lots.
For patients who got a med, but don’t know if it’s NECC
First, defer to FDA on meds that NECC produced.
We should emphasize that at this time, CDC is only aware of infections occurring in patients who
have received epidural steroid injections with product from the lots recalled on Sept 25.
However, if a patient believes that they received another medication produced by NECC, and
they are concerned that they may have illness related to this medication, they should seek
medical care.
4. If a patient had their injection with another lot from the pharmacy, do they need to be
concerned?
However, clinicians should immediately cease use and remove from their pharmacy inventories
any product produced by the New England Compounding Center until investigation by the FDA
and the Massachusetts Board of Pharmacy has been completed. Furthermore,
To date, CDC is only aware of infections associated with the 3 lots that were recalled on
September 25. However, physicians and healthcare providers should be vigilant for any signs of
infection that may be related to use of a product produced by NECC. Documented infections
that may be associated with one of these products should be reported to their state health
departments.
5. Is there an effective treatment for these infections?
CDC has consulted with national experts and developed interim guidance on treatment options
for patients infected as part of this outbreak. This is available through state health
departments, who should be notified when infected patients are identified.
Physicians should follow routine treatment protocols for meningitis of unclear etiology,
including covering for potential bacterial causes of meningitis. However, until we know more
about these infections, physicians are encouraged to add empiric antifungal therapy to the
treatment regimen because of the severe adverse outcomes of untreated fungal meningitis.
6. Is there a medication that people were potentially exposed can take to prevent infection?
The investigation into the cause of the outbreak is ongoing. Because the medical treatment for
this infection is not benign, CDC does not recommend routine prophylaxis of patients who have
received medication from one of these lots.
Pharmacy Questions:
1. Are patients who received other products from NECC at risk?
FDA to respond.
CDC: At this time, CDC is only aware of infections occurring in patients who have received
epidural steroid injections with product from the recalled lots.