News & Press: Patient Safety

UPDATE: Urgent Drug Recall Information - Multi-State Outbreak of Meningitis Following Epidural Injec

Thursday, October 4, 2012  
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HIGHLIGHTS

 

  • 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 affected?

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.

Advice to Healthcare Providers

 

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

The potentially contaminated injections were given starting May 21, 2012. Symptoms that should prompt diagnostic evaluation include:

 

  • Worsening headache
  • Fever
  • Sensitivity to light
  • Nausea or vomiting
  • Stiff neck
  • New 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.

 

Early detection and treatment of this rare, but serious fungal infection has the potential to greatly improve the outcome for infected patients.

 

ISIS Statement Regarding the Outbreak

Our 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.

 

The CDC 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.

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CDC and FDA Sites for Updates and Additional Information

 

CDC

Daily Updates (2pm ET) on the CDC website: http://www.cdc.gov/hai/outbreaks/meningitis.html

 

 

 

FDA

FDA website for information on the outbreak: http://www.fda.gov/Drugs/DrugSafety/ucm322734.htm.

 

Clinicians 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.

 

 

 

 

 


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