UPDATE: Urgent Drug Recall Information - Multi-State Outbreak of Meningitis Following Epidural Injec
Thursday, October 4, 2012
- 375 people have been diagnosed with fungal meningitis (with or without other infection)
- 6 people have suffered stroke without lumbar puncture only
- 268 people have been diagnosed with paraspinal/spinal infection only
- 1 patient has been diagnosed with paraspinal/spinal injection and peripheral joint infection
- 44 people have died
WHAT WE KNOW NOW
Who has been
As of Monday,
January 14, 2013, 649 people in 19 states (Tennessee, North Carolina, Florida, Virginia,
Indiana, Maryland, Michigan, Ohio, Minnesota, New Jersey, Idaho, Texas,
Illinois, New Hampshire, Pennsylvania, New York, Georgia, South Carolina and
Rhode Island) have been diagnosed with fungal
meningitis, stroke due to presumed fungal meningitis, or other central nervous
system-related infection meeting the outbreak case definition, following
epidural steroid injection. Twenty-eight additional patients have been diagnosed with
peripheral joint infections for a total of 678 infected patients. Forty-four people have died. CDC’s fungal disease laboratory has
confirmed the presence of three types of fungus in patients with meningitis: Exserohilum, Aspergillus, and Cladosporium, with Exserohilum
being present in the vast majority of those patients.
Patients who received the NECC products should be advised of the symptoms of possible infection and instructed to contact their physician or another healthcare provider immediately if they experience any of these symptoms (see Advice to Concerned Patients). Physicians should report any suspicious cases following use of other NECC products to the state and local health authorities.
In addition to addressing management of patients with fungal meningitis and peripheral joint infections, CDC’s current diagnostic and treatment guidance addresses management of patients with epidural abscess or other complications at or near the injection site. These localized infections may occur in isolation or in patients previously diagnosed with fungal meningitis. Although patients with these localized infections frequently have new or worsening back pain, symptoms may be mild or clinically difficult to distinguish from the patient’s baseline chronic pain. Based on current information, CDC recommends the following diagnostic protocol:
- In patients with new or worsening symptoms at or near the injection site, physicians should obtain an MRI with contrast of the symptomatic area(s), if not contraindicated. This recommendation also applies to patients being treated for meningitis. 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.
- CDC has received reports of patients being treated for fungal meningitis who had no previous evidence of localized infection at the site of injection, but who were subsequently found to have evidence of localized infection (e.g., epidural abscess, phlegmon, discitis, vertebral osteomyelitis, or arachnoiditis) on imaging studies. Therefore, in patients being treated for meningitis, even in the absence of new or worsening symptoms at or near the injection site, clinicians should strongly consider obtaining an MRI of the injection site approximately 2-3 weeks after diagnosis of meningitis. Early identification of new disease may facilitate additional specific interventions (e.g., drainage) and provide information for measuring effectiveness of therapy thereafter.
- For patients demonstrated to have epidural abscess, phlegmon, discitis, vertebral osteomyelitis, or arachnoiditis, early consultation with a neurosurgeon to discuss whether surgical management, including debridement, is warranted in addition to antifungal therapy (for information about antifungal therapy, see Interim Treatment 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).
CDC continues to gather data from existing and newly reported cases of infection and will use this information to inform updates to existing guidance. Healthcare professionals with patients under their care should check CDC’s website for the most up-to-date clinical guidance because information is subject to change.
CDC has established a volunteer Clinicians Consultation Network of experts in fungal disease treatment and management to assist physicians who are directly involved in the treatment of patients associated with the current outbreak of fungal meningitis and other infections. Through this service, doctors who are treating patients will be able to consult by telephone or email with one of a group of participating infectious disease medical experts. To access the service, physicians should call 1-800-CDC-INFO (1-800-232-4636) and then select the appropriate prompts (e.g., "1” for English, "1” for Clinician).
Advice to Concerned Patients
potentially contaminated injections were given starting May 21, 2012. Symptoms that should
prompt diagnostic evaluation include:
weakness or numbness in any part of your body
- Slurred speech
- Altered mental status
- Increased pain, redness, or swelling
of the injection site
Typically in this outbreak, symptoms
have appeared one to four 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.
detection and treatment of this rare, but serious fungal infection has the
potential to greatly improve the outcome for infected patients.
Statement Regarding the Outbreak
thoughts and prayers go out to the patients and families affected by this
outbreak. This is also a tragedy for the providers who obtained medications
from a large and reputable source and now are a direct part of this horrific
outbreak. Steroid injections are safe. Thousands
are administered every year and countless numbers of patients obtain relief as
a result. The number of patients who develop severe complications as a
result is incredibly low. The incidence of infection is thought to be less than
1:100,000. Death is extremely rare.
The medication in question, methylprednisolone acetate,
waswidely available in single dose vials at a reasonable cost, and the
source ofthe infection was not a breach in injection
safetyprotocol. Rather, the source appears to becontamination of
the medication vials at the compounding pharmacy, NECC. Most providers using
the NECC compounded methylprednisolone did so in order to obtain a specific
preservative-freepreparation that is not commercially available, and not to
lower cost or obtain single dose vials.
had requested ISIS assistance in disseminating information to specialty
societies when the outbreak was first suspected, and we continue to communicate
directly with the CDC to provide any assistance we can.
CDC and FDA Sites for Updates and
Updates (2pm ET) on the CDC website: http://www.cdc.gov/hai/outbreaks/meningitis.html
for information on the outbreak: http://www.fda.gov/Drugs/DrugSafety/ucm322734.htm.
should inform their State health department of any patients undergoing
evaluation for this infection. Clinicians should report any suspected adverse
events following use of these products to FDA's MedWatch program at
1-800-332-1088 or www.fda.gov/medwatch.