Oct 8, 2012 (CIDRAP News) – The number of patients sickened in a fungal meningitis outbreak linked to steroid injections for back pain more than doubled over the weekend, with 105 infections reported so far, including 3 more deaths, raising the toll to 8, the US Centers for Disease Control and Prevention (CDC) said today in a health alert.
Minnesota and Ohio reported their first cases, raising the number of affected states to nine. The three new deaths included two patients from Michigan and one from Tennessee. The CDC had reported 47 cases with 5 deaths on Oct 5.
The identification of the new cases follows the Oct 5 CDC release of a list of 75 healthcare facilities in 23 states that received the contaminated products, which include three lots of preservative-free methylprednisolone acetate prepared by New England Compounding Center (NECC) in Framingham, Mass. Pain clinics use the drug for injections in and around the spinal cord.
The infections are not contagious, but some of them have been severe, and some patients have suffered strokes, the CDC said. Some other patients' symptoms were very mild.
No other products from NECC have been linked to the outbreak, but on Oct 6 the company expanded its recall to include all products that were compounded and distributed at its Framingham facility, according to an Oct 6 recall update from the Food and Drug Administration (FDA). The CDC said it is not asking clinicians to contact patients who were treated with the company's other products, aside from the ones that have already been implicated in the outbreak.
Meanwhile, the CDC expanded its warning to include patients who had any type of injection after May 21, 2012, with any of the recalled lots. Its earlier warning covered just epidural injections administered since July. So far no infections related to peripheral joint-space injections with drugs from the recalled lots have been reported.
The CDC says the company's recall hasn't changed its guidance to patients: those who feel sick and are concerned that they may have received medication from NECC should contact their physicians. Symptoms that should spark prompt evaluation include fever, a new or worsening headache, neck stiffness, sensitivity to light, new weakness or numbness, and increasing pain, redness, or swelling at the injection site.
The CDC has released a case definition to help clinicians identify affected patients. It includes a person with:
- subacute meningitis onset 1 to 4 weeks following epidural injection after May 21,
- basilar stroke 1 to 4 weeks following an epidural after May 21, without having received a diagnostic lumbar puncture,
- evidence of spinal osteomyelitis or epidural abscess at the site of an injection administered after May 21, or
- septic arthritis diagnosed 1 to 4 weeks after a steroid joint injection received after May 21
The number of patient samples that were positive for fungus, including Aspergillus and Exserohilum, remained at nine, the CDC said. Postmortem testing on one patient also turned up Propionibacterium acnes, but it's unclear if the finding is clinically significant, the CDC said.
In other developments, the CDC on Oct 6 released a host of resources for clinicians, including guidance documents. It said it does not recommend lumbar punctures for patients who were exposed to the recalled medication who are currently asymptomatic and at this time does not recommend antifungal prophylaxis for patients who are asymptomatic and/or have normal cerebrospinal fluid on laboratory examination.
Oct 8 CDC health advisory
Oct 6 FDA recall update
Oct 6 CDC fungal meningitis outbreak case definition
Oct 6 CDC interim treatment guidance
Oct 6 CDC lumbar puncture guidance
Oct 6 CDC antifungal prophylaxis guidance