Fungal Meningitis and Steroid Injections (cont.)

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Another company, Ameridose, LLC, who shares management personnel with the New England Compounding Center (NECC), voluntarily recalled all of its unexpired products from its customers on Oct. 31, 2012, although none of their products have shown contamination to date. However, the FDA found concerns about sterility procedures while investigating Ameridose, LLC, and its related NECC facility.

On Nov. 1, the CDC Health Advisory reported that additional compounded products, produced by NECC, were found to be contaminated with bacteria (mainly Bacillus spp); fungal culture results are still pending. One such compound was cardioplegia fluid, used to stop the heart during cardiac surgery.

To date (Nov. 5, 2012), 419 patients have been diagnosed with fungal meningitis and 30 patients have died (a death rate of 7%). The CDC estimates that about 13,000 people may have been exposed to the fungal contaminated batch of medication. Fortunately, fungal meningitis is not contagious. However, in September, the CDC reportedly suspected many more individuals would be detected with fungal meningitis because of the potentially long period of time before some symptoms develop and the large number of exposed patients. This has proven to be accurate because the number of people who have been diagnosed or died has approximately tripled since the CDC first stated its suspicions about detectable infections and deaths. In addition, 10 patients have had peripheral joint infections develop (for example, knee, shoulder, hip, and elbow) but no deaths have been associated with these joint infections to date.

In Michigan, the state that has reported the highest number of fungal meningitis infections due to contaminated steroid injections, physicians are reporting that about one-third of 53 patients treated for the disease and sent home are now returning to the hospital with epidural abscesses. Epidural abscesses are collections of pus, usually due to a bacterial or fungal infection, that occur between the outer covering of the spinal cord and the spine; it may also occur between the outer covering of the brain and skull. The main symptoms of these infections are severe pain at the injection site; diagnosis is made by CT or MRI because the abscess is located so deep in the body it gives no visible sign of infection. If not treated quickly with appropriate antifungal or antimicrobial drugs and possibly surgical drainage of the pus, patients can develop weakness, paralysis, permanent nerve damage, osteomyelitis, meningitis, or death. This situation has been documented in a few patients in Tennessee also. Unfortunately, this newest noted "late occurring" complication may be found as more patients complete their treatment for fungal meningitis caused by a contaminated steroid injection.