From a CDC health advisory, “The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are coordinating a multi-state investigation of fungal meningitis among patients who received an epidural steroid injection.” Some people suffered strokes believed to have been caused by this infection.
Five deaths have been reported as of October 4, 2012. From data collected to date, all infected patients were injected with a preservative-free methylprednisolone acetate (80mg/ml). This medication, prepared by New England Compounding Center (NECC), located in Framingham, MA, was found to contain Aspergillus fumigatus, causing the fungal meningitis. The FDA observed the fungal contamination by direct microscopic examination of foreign material taken from a sealed vial of the medication collected by the NECC.
The Tennessee Department of Health notified the CDC of a patient who contracted meningitis about 19 days after receiving an epidural steroid injection at an outpatient surgery center. This led to a broader investigation which uncovered a total of 35 cases from six states as of Oct. 4.
The compounding center has ceased all production and initiated a recall of all methylprednisolone acetate and other drug products prepared for intrathecal administration. The NECC has also closed and surrendered their licenses voluntarily until further notice.
Georgia is one of several states that receives this medication for spinal and joint injections. The FDA is taking an additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. Health care professionals should retain and secure all remaining products purchased from NECC until FDA provides further instructions regarding their proper disposal.
To be clear, three lots were found to be contaminated, but all products distributed by the NECC should be considered suspect. Patients recently injected should receive a follow-up call to determine possible symptoms of fungal meningitis.
Users of the medication should also notify the FDA of any complaints or problems associated with these medications. Reports may be made to MedWatch, the FDA’s voluntary reporting program, by phone at 1-800-FDA-1088 or on line at fda.gov/medwatch/report.
As a means of controlling severe chronic back and joint pain through a steroid injection rather than narcotics, many people view this treatment as a more natural alternative. The steroids serve to reduce the internal swelling that puts pressure on nerves.