Distributed via the CDC Health Alert NetworkMarch 4, 2013, 16:30 ET (4:30 PM ET)CDCHAN-00342
CDC continues to receive new reports of fungal infection among patients who were given injections of contaminated methylprednisolone acetate (MPA1) from the New England Compounding Center (NECC) in Framingham, Mass. Most of these recent cases have been localized spinal or paraspinal infections (e.g., epidural abscesses) in patients, although new cases of meningitis or arachnoiditis also have been reported. Because many of these new cases are among patients with minimal symptoms, CDC is re-emphasizing the recommendation for clinicians to remain vigilant for fungal infections, especially in patients with mild or even baseline symptoms, and consider evaluation with magnetic resonance imaging (MRI) if clinically warranted. This Health Alert Network (HAN) notice provides the following:
As of March 4, 2013, a total of 720 cases, which includes 48 deaths, have been reported in 20 states. Current information about the outbreak, including case counts and distribution by state, and clinician and patient guidance, is available online.
Over the past several months, there has been a marked decrease in reports of fungal meningitis, but CDC continues to receive reports of localized spinal and paraspinal infections, which include epidural abscess, phlegmon, arachnoiditis, and discitis. Additionally, some of these newly identified case-patients had initially tested negative for signs of a fungal infection (either by lumbar puncture or MRI) and have subsequently developed fungal infection, indicating a prolonged incubation period.
After the recall of NECC steroid medications on September 26, state and local health departments identified almost 14,000 people in 23 states who were potentially exposed to the implicated MPA; of these, an estimated 11,000 individuals received spinal or paraspinal injections. Through active notification by clinics with assistance from states and CDC in early October, nearly all of these exposed persons were contacted at least once and informed of their risk for fungal infection as a result of receiving injections with contaminated medication.
Despite this and subsequent patient outreach efforts, CDC and public health partners remain concerned about the potential for some exposed patients to have localized fungal infections that have gone unrecognized. These infections may be unrecognized because some patients have not continued to receive close clinical follow-up or because they have not recognized symptoms suggestive of a localized infection, which may be difficult to distinguish from their baseline chronic pain.
As described in CDC’s HAN update on December 20, MRI testing was done on 128 patients in Michigan, Tennessee, and North Carolina who had no previous evidence of infection and had new or worsening symptoms at or near the site of their spinal or paraspinal injection. Of these, 67 (52%) had findings suggestive of localized infection. In addition, of 109 different patients reporting persistent but baseline symptoms at or near the site of their spinal or paraspinal injection, 15 (14%) also had abnormal MRI findings suggestive of infection, and 27 (25%) had non-specific enhancement of soft tissue or other paraspinal structures. The clinical significance of these findings is unclear; however, there is a theoretical risk that failure to diagnose these infections in a timely fashion could result in poor outcomes for patients (e.g., neurologic compromise, osteomyelitis, or progression to meningitis.)
Early in the outbreak, CDC advised clinicians to closely monitor and evaluate patients who received injections of implicated MPA. Additional guidance was provided in HAN updates issued on November 20 and December 20. Because of the possibility that some patients may have unrecognized, localized fungal infections, CDC is re-emphasizing the following recommendations for patients who received a spinal or paraspinal injection with implicated MPA:
Call In response to input from expert consultants on fungal disease and physicians who have been treating patients affected by this outbreak, CDC has revised its Interim Treatment and Diagnostic Guidance for Central Nervous System and Parameningeal Infections Associated with Injection of Contaminated Steroid Products. The revisions include addition of new information on several topics, including:
A conference call for clinicians interested in obtaining additional information about the management and treatment of patients with fungal illness associated with this outbreak has been scheduled for March 13 at 5:00 p.m. The presenter will be Tom Chiller, MD, medical officer, CDC. Registration and call-in information and other details about the conference call will be available on CDC’s website.
1NECC lots of methylprednisolone acetate (PF) 80mg/ml:
1300 Wilson Boulevard | Suite 300 | Arlington, VA 22209 | Phone: (703) 299-0200 | Fax: (703) 299-0204
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