Fungal Infections from Contaminated Medication:
Information for Health Professionals

(Updated 11/26/2012)

On this page:
Update
Background & Investigation
Recalled Products
Diagnostic Testing
Clinical Case Submission (Reporting)
Clinical Guidance

Update

A second wave of infections and complications other than fungal meningitis are being seen in patients who have received injections with contaminated products from the New England Compounding Center (NECC). Patients may have epidural abscess, discitis, vertebral osteomyelitis, arachnoiditis, cauda equina syndrome, or other complications at or nearby the injection site alone or in addition to meningitis. Strong consideration should be given to obtaining imaging of the symptomatic area(s) and the injection site, even when minimal symptoms are reported. Repeat imaging, lumbar puncture (LP), and close follow-up are highly recommended in patients with new or worsening symptoms including patients on treatment for fungal meningitis. In addition, clinicians are encouraged to repeat imaging 2-3 weeks after the diagnosis of meningitis in patients who do not have new signs or symptoms.

Background & Investigation:

A nationwide investigation of fungal infections associated with contaminated products from the NECC is ongoing. Fungal infections should not be confused with the viral or bacterial forms of the illness with which most people are familiar.
This form of the illness cannot be transmitted from person to person.

Recalled Products:

The compounding pharmacy implicated in this outbreak is the NECC, located in Framingham, MA.
All products from NECC have been recalled.
  • Follow updated FDA guidance, including:
    • Review purchasing records and inventory to see if you received any products produced by NECC after May 21, 2012.
    • Notify all patients who received any injectable medications from NECC, with special attention to ophthalmic drugs that are injectable or used in conjunction with eye surgery. In addition, notify patients who received cardioplegic solutions. 
    • Report adverse events or side effects related to these medications to the FDA MedWatch and also call MDH at 651-201-5414.
  • Of particular concern are three contaminated lots of methylprednisolone acetate distributed by NECC after May 21, 2012, generally administered epidurally or into joints to manage pain. In Minnesota, facilities that have received product from these lots of contaminated methylprednisolone acetate include: Medical Advanced Pain Specialists (MAPS) in Edina, Fridley, Shakopee and Maple Grove, and the Minnesota Surgery Center (MSC) in Edina and Maple Grove.
    • Persons who received potentially contaminated methylprednisolone acetate injections from these lots were contacted by their clinic or by MDH in early October.

Diagnostic Testing:

Patients who received a NECC product after May 21, 2012 may have epidural abscess, discitis, vertebral osteomyelitis, or other complications at or nearby the injection site. Strong consideration should be given to imaging the symptomatic area(s), even when minimal symptoms are reported from the area(s). Repeat imaging, LP and close observation of patients who received contaminated product are highly recommended.

For patients who received an epidural injection with a NECC product after May 21, 2012 and have symptoms of meningitis or basilar stroke, a diagnostic lumbar LP should be performed, if not contraindicated. Because presenting symptoms of some patients with meningitis have been mild and not classic for meningitis (e.g., new or worsening headache without fever or neck stiffness), physicians should have a low threshold for performing an LP.


Clinical Case Submission (Reporting):

Clinical Guidance:

There are reports of patients treated for fungal meningitis who have developed new or worsening symptoms related to the fungal infection including arachnoiditis, cauda equina syndrome, epidural abscesses or other complications. Clinicians should strongly consider imaging of the site of injection and other suspected sites of involvement if new or worsening symptoms develop. Early consultation with a neurosurgeon may be warranted. In patients who have not developed new symptoms, clinicians are encouraged to image the site of injection 2-3 weeks after diagnosis of meningitis. 

Patients have also presented with clinically diagnosed meningitis and an abnormal spinal tap, early initiation of treatment is critical to prevent worsening of infection and associated severe complications. Clinically diagnosed meningitis means a patient has one or more of the following symptoms: fever, or new or worsening headache, stiff neck, or photophobia, in addition to a CSF profile showing pleocytosis of >5 white blood cells (adjusted for the presence of red blood cells by subtracting 1 white blood cell for every 500 red blood cells).

At this time, it is NOT recommended to initiate antifungal treatment in exposed patients who are asymptomatic. These patients should continue to be closely monitored for development of symptoms, with a low threshold for performing LP and imaging should the patient become symptomatic.

Updated Tuesday, 27-Nov-2012 08:10:55 CST