Notice to Clinicians: Continued Vigilance Urged for
Fungal Infections among Patients Who Received
Contaminated Steroid Injections
The CDC
continues to receive new reports of fungal infection among patients who
were given injections of contaminated methylprednisolone acetate (MPA)
from the New England Compounding Center (NECC) in Framingham, Mass.
Most of these recent cases have been localized spinal or paraspinal
infections (e.g., epidural abscesses) in patients, although new cases of
meningitis or arachnoiditis also have been reported. Because many of
these new cases are among patients with minimal symptoms, CDC is
re-emphasizing the recommendation for clinicians to remain vigilant for
fungal infections, especially in patients with mild or even baseline
symptoms, and consider evaluation with magnetic resonance imaging (MRI)
if clinically warranted.
Status of Fungal Disease Outbreak
As of March 4, 2013, a total of 720 cases, which includes 48 deaths, have been reported in 20 states. Current information about the outbreak, including case counts and distribution by state, and clinician and patient guidance, is available online at http://www.cdc.gov/hai/outbreaks/meningitis.html.
As of March 4, 2013, a total of 720 cases, which includes 48 deaths, have been reported in 20 states. Current information about the outbreak, including case counts and distribution by state, and clinician and patient guidance, is available online at http://www.cdc.gov/hai/outbreaks/meningitis.html.
Over
the past several months, there has been a marked decrease in reports of
fungal meningitis, but CDC continues to receive reports of localized
spinal and paraspinal infections, which include epidural abscess,
phlegmon, arachnoiditis, and discitis. Additionally,
some of these newly identified case-patients had initially tested
negative for signs of a fungal infection (either by lumbar puncture or
MRI) and have subsequently developed fungal infection, indicating a
prolonged incubation period.
After
the recall of NECC steroid medications on September 26, state and local
health departments identified almost 14,000 people in 23 states who
were potentially exposed to the implicated MPA; of these, an estimated
11,000 individuals received spinal or paraspinal injections. Through
active notification by clinics with assistance from states and CDC in
early October, nearly all of these exposed persons were contacted at
least once and informed of their risk for fungal infection as a result
of receiving injections with contaminated medication.
Despite this and subsequent patient outreach efforts, CDC and public health partners remain concerned about the potential for some
exposed patients to have localized fungal infections that have gone
unrecognized. These infections may be unrecognized because some patients
have not continued to receive close clinical follow-up or because they
have not recognized symptoms suggestive of a localized infection, which
may be difficult to distinguish from their baseline chronic pain.
As described in CDC’s HAN update on December 20 (http://emergency.cdc.gov/HAN/han00338.asp),
MRI testing was done on 128 patients in Michigan, Tennessee, and North
Carolina who had no previous evidence of infection and had new or
worsening symptoms at or near the site of their spinal or paraspinal
injection. Of these, 67 (52%) had findings suggestive of localized
infection. In addition, of 109 different patients reporting persistent
but baseline symptoms at or near the site of their spinal or paraspinal
injection, 15 (14%) also had abnormal MRI findings suggestive of
infection, and 27 (25%) had non-specific enhancement of soft tissue or
other paraspinal structures. The clinical significance of these findings
is unclear; however, there is a theoretical risk that failure to
diagnose these infections in a timely fashion could result in poor
outcomes for patients (e.g., neurologic compromise, osteomyelitis, or
progression to meningitis)
Patient and Clinician Recommendations
Early
in the outbreak, CDC advised clinicians to closely monitor and evaluate
patients who received injections of implicated MPA. Additional guidance
was provided in HAN updates issued on November 20 (http://emergency.cdc.gov/HAN/han00335.asp) and December 20 (http://emergency.cdc.gov/HAN/han00338.asp).
Because of the possibility that some patients may have unrecognized,
localized fungal infections, CDC is re-emphasizing the following
recommendations for patients who received a spinal or paraspinal
injection with implicated MPA:
Patients
Patients who received an injection in or near their spine from one of the three implicated lots of MPA1
and who have any symptoms at or near the site of their injection should
seek evaluation by their medical provider for the possibility of a
localized infection, such as an epidural abscess. This includes
patients who initially received steroid injections for pain and continue
to have persistent baseline pain.
Clinicians
As
a part of continued monitoring of patients who received an injection
with implicated MPA, clinicians should consider re-evaluating patients who received a spinal or paraspinal injection with implicated MPA
for signs and symptoms suggestive of infection, including any symptoms
at or near the site of their injection. Because of the prolonged
incubation period for these infections, this guidance pertains both to
patients who have not been previously evaluated and to those who have
already had a prior negative evaluation (e.g., normal cerebrospinal
fluid profile, normal findings on MRI) but continue to have complaints:
- In
patients with new or worsening symptoms at or near the site of their
injection, clinicians should obtain an MRI with contrast of the
symptomatic area(s).
- In
patients with persistent but baseline symptoms, clinicians should
consider obtaining an MRI with contrast of the symptomatic area(s)
because the presentation of spinal or paraspinal infections can be
subtle, and may be difficult to distinguish from a patient’s baseline
chronic pain.
- In
some cases, radiologic evidence of abscess or phlegmon has become
apparent on repeat MRI studies performed subsequent to an initially
normal imaging procedure. Clinicians should therefore have a low
threshold for repeat MRI studies in patients who continue to have
symptoms localizing to the site of injection, even after a normal study.
However, the optimal duration between MRI studies is unknown.
- Clinicians
should also consider reviewing MRI results with a neuroradiologist
because of potential difficulties in interpreting imaging results for
these patients.
Revised Clinical Guidance and Clinician Information Call
In
response to input from expert consultants on fungal disease and
physicians who have been treating patients affected by this outbreak,
CDC has revised its Interim Treatment and Diagnostic Guidance for
Central Nervous System and Parameningeal Infections Associated with
Injection of Contaminated Steroid Products (http://www.cdc.gov/hai/outbreaks/clinicians/guidance_cns.html). The revisions include addition of new information on several topics, including:
- Surgical management of parameningeal disease
- Duration of antifungal treatment
- Monitoring clinical status after cessation of antifungal treatment
- Information on non-first-line medications (e.g., posaconazole or itraconazole)
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1NECC 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
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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