The outbreak of fungal meningitis spread by contaminated injections of methylprednisolone has affected 414 patients in 19 states as of November 7, according to CDC reports. The agency has also confirmed 31 deaths.
Since the initial discovery of fungal meningitis linked to products compounded at the New England Compounding Center (NECC), all products manufactured by NECC have been recalled, as well as all those manufactured by Ameridose, which shares management with NECC. FDA and CDC are conducting an investigation of the causes of the outbreak, which continues to affect patients across the country.
Earlier this week, CDC acknowledged new reports of spinal epidural abscess and arachnoiditis in patients undergoing treatment for fungal meningitis, describing them as “rare but serious disorders … that require prompt medical attention.” The agency noted that most reports were localized in Michigan and Tennessee, but that cases have been observed in other states as well.
CDC’s announcement followed a New York Times report last week that “about a third of the 53 patients treated for meningitis at St. Joseph Mercy Hospital in Ann Arbor, MI, have returned with abscesses” and “a few cases of epidural abscess” had occurred in Tennessee as well. The Times quoted Lakshmi Halasyamani, MD, Chief Medical Officer of St. Joseph Mercy Hospital, as commenting, “This is a significant shift in the presentation of this fungal infection and quite concerning. An epidural abscess is very serious. It’s not something we expected.”
According to CDC, it is unknown at this time how many patients have developed these conditions or why they occurred. The agency noted that symptoms of epidural abscess include fever, headache, back pain, and neurological problems, while symptoms of arachnoiditis include numbness, tingling, and burning pain in the lower back or legs, as well as muscle cramps, twitches, or spams; bladder, bowel, or sexual function problems; and paralysis of the lower limbs. CDC urged health professionals to treat patients who present with arachnoiditis even though the condition is not currently mentioned in the agency’s case definition for the outbreak.
FDA and CDC have recorded 75 laboratory-confirmed cases meningitis caused by Exserohilum rostratum, the fungus that appears to have caused almost all the cases. The index case remains the only one in which the infection was caused by an Aspergillus fungus.
As part of the agencies’ ongoing inspection of unopened methylprednisolone vials, E. rostratum has been found in two of the three initially implicated lots. Tests continue on the third lot.
FDA and CDC are also conducting tests on other NECC products, including preservative-free injectable betamethasone and cardioplegia solution. Last week, the agencies reported that they identified various species of Bacillus and related bacteria in three separate lots of betamethasone and one lot of cardioplegia. The clinical significance of these results is unknown, and CDC has not received laboratory-confirmed reports of infection linked to these bacteria or products.