A new health-care-related disease has been identified by the U.S. Centers for Disease Control and Prevention (CDC). The disease is fungal meningitis caused by fungal-contaminated steroid injections. While it is not new per se, it was newly found to be health-care-related because the disease is linked to a treatment known as epidural steroid injections, a treatment designed to reduce pain and inflammation in a person's back. According to the CDC, a company, the New England Compounding Center in Framingham, Mass., produced about 17,000 vials of methyl prednisolone acetate that were eventually determined to be likely contaminated by a fungus that rarely causes meningeal infections (infections of the lining tissue of the brain and spinal cord, see Figure 1). The vials were shipped to 23 states and the first doses from the contaminated vials were started on May 21, 2012. Some patients who obtained these epidural injections began showing symptoms of fungal meningitis during the summer such as "fever, new or worsening headache, neck stiffness, sensitivity to light, new weakness or numbness, increasing pain, redness or swelling of the injection site" and the CDC traced the fungal contamination back to the epidural medication vials. The vials were recalled Sept. 26, but patients may have obtained injections from about the last week of May to the last week of September. Since September, other infections have been noted in joints injected with similar NECC steroid preparations thus causing another health-care-related disease, bacterial joint infections, caused by contaminated steroid injections supplied to doctors by NECC.
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.
There are now five aspects of this health-care-related fungal meningitis infection that are concerning. First, the infection may take a long time (from two to 28 days; some may take even more time) to begin to develop the symptoms listed above. Second, several of the patients developed strokes due to the infection; and third, the steroid medications suppress inflammation and may make the individual more susceptible to infectious agents. Fourth, fungal meningitis is difficult to treat and usually requires at least two antifungal drugs given intravenously over an extended time period (months). The last or fifth aspect is that a number of patients treated for fungal meningitis may return with an epidural abscess. Consequently, compounded drugs, especially those containing steroids that are contaminated with fungi or bacteria, are likely to be difficult to both diagnose and treat.
A map and graph of people by state with fungal meningitis or joint infections is constantly updated by the CDC. This CDC site is http://www.cdc.gov/hai/outbreaks/meningitis-map.html and has the most up-to-date statistics on morbidity (people diagnosed) and mortality (deaths) from these health-care-related diseases.
Drug compounding centers are not regulated by the high standards that drug producers must meet. Most compounding centers are regulated by state agencies and not by the stricter FDA rules that are applied to drug producers. This current outbreak of fungal meningitis, joint infections, and other infections such as epidural abscesses related to products used to treat patients is likely to change this "oversight or regulation" situation. Currently, several high-ranking politicians are demanding stricter regulations be set up for drug-compounding companies. The FDA commissioner, the NECC cofounder, and the director of the Massachusetts Board of Registration in Pharmacy are scheduled to meet with a congressional panel on Nov. 14, 2012. Confidence in compounded drugs can be brought back to the many doctors and patients who need to use them only if such incidences of contaminated drugs from compounding centers are substantially reduced or eliminated.
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Calvan, Bobby Caina and Globe Staff. "Compounding Pharmacies Have Long Evaded the Tight Oversight Governing Established Drug Makers." The Boston Globe Oct. 29, 2012. <http://www.boston.com/business/news/2012/10/29/compounding-pharmacies-have-long-evaded-the-tight-oversight-governing-established-drug-makers/KCnU0fS75nFlsJSUoDroyI/story.html>.
United States. Centers for Disease Control and Prevention. "CDC Responds to Multistate Outbreak of Fungal Meningitis and Other Infections." Nov. 2, 2012. <http://www.cdc.gov/HAI/outbreaks/currentsituation/>.
United States. Centers for Disease Control and Prevention. "Multistate Meningitis Outbreak Investigation." Oct. 8, 2012. <http://www.cdc.gov/HAI/outbreaks/meningitis.html>.