A rare form of fungal meningitis, according to the Centers for Disease Control and Prevention (CDC), has been confirmed so far in 91 patients in Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia. At least eight people have died.
The North American Spine Society (NASS) issued a Spine Safety Alert on October 4.
The patients were exposed to the fungus when they went to physicians in July and August for epidural steroid injections to treat back, neck, knee and other types of pain. The injections are a common treatment for sciatica. According to published reports, as many as 2.5 million Medicare beneficiaries receive such injections each year.
New England Compounding Center
On September 21, 2012, CDC was notified by the Tennessee Department of Health of a patient with the onset of meningitis approximately 19 days following epidural steroid injection at a Tennessee ambulatory surgery center. More were reported and one of the first patients died.
A compounder named the New England Compounding Center (NECC) was quickly identified as the source of the contaminated injection. Three following lots of Methylprednisolone Acetate were recalled from NECC on September 26, 2012:
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Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
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Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
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Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013
On September 28, investigators identified a case outside of Tennessee, possibly indicating contamination of a widely distributed medication.
Spine Safety Alert
By October 2, the North American Spine Society began to tweet and post news about the outbreak on its Facebook site. By October 4, the Society issued a Spine Safety Alert via email to 25, 000 members and non-members.
On October 6, 2012, NECC, following an earlier recommendation by FDA that none of the firm’s compounded products be used, announced a voluntary recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts.
Methylprednisolone Acetate
Investigation into the exact source is ongoing; however, interim data show that all infected patients received injection with preservative-free methylprednisolone acetate (80mg/ml) prepared by NECC.
Patients and Instructions
FDA requests that health care professionals retain and secure all remaining products purchased from NECC until FDA provides further instructions regarding the disposition of these products.
According to the CDC, 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 new neurological deficit (consistent with deep brain stroke). Some of these patients’ symptoms were very mild in nature. CSF (cerebrospinal fluid) obtained from these patients has typically shown elevated white cell count (with a predominance of neutrophils), low glucose, and elevated protein.
The CDC says physicians should contact patients who have had an injection (e.g., spinal, joint) using any of the three lots of methylprednisolone acetate listed above to determine if they are having any symptoms.
For patients who received epidural injection and have symptoms of meningitis or basilar stroke, a diagnostic lumbar puncture (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 LP. While CDC is aware of infections occurring only 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 (e.g., swelling, increasing pain, redness, warmth at the injection site) and should be encouraged to seek evaluation (e.g., arthrocentesis) if such symptoms exist.
Oversight
This situation raised issue regarding oversight of manufacturers, compounders and distributors of these products. Ray Baker, M.D., president of the International Spine Intervention Society, told us this case may have much to do with the fact that physicians don’t want to use near the spine some of the preservatives normally found in these compounds. He said physicians need help in obtaining appropriate sized vials of product at reasonable prices and prepared in a way that can be safely used around the spine.
To read the latest on the NASS Drug Alert with links to appropriate regulatory agencies, click here.
