CDC and FDA: Meningitis Toll Rising
Thirty-five people in six states have been sickened by a rare form of meningitis, which has been linked to three recalled lots of an injectable steroid, and five have died, the CDC said in a press briefing Thursday afternoon.
Hardest hit is Tennessee, which is reporting 25 cases and three deaths, according to Benjamin Park, MD, of the CDC's mycotic diseases division.
"We expect to see additional cases as this investigation unfolds," Park told reporters in the telephone briefing.
While the cause of the outbreak remains unclear, officials suspect three lots of preservative-free methylprednisolone acetate manufactured by the New England Compounding Center in Framingham, Mass.
FDA investigators, examining an unopened vial of the substance at the company's plant, found "foreign matter" that turned out under microscopic study to be a fungus, according to Ilisa Bernstein, PharmD, of the agency's Center for Drug Evaluation and Research.
The exact type of fungus is still under study, she told reporters.
So far, analysis has also identified a fungus in the CSF of five of the affected patients, according to Park.
The compounding pharmacy has voluntarily stopped making and distributing its products, and the FDA is urging doctors to avoid use of any part of the recalled lots or any other product intended for intrathecal injection.
The company's website was offline Thursday.
The steroid is used to control back pain and the people involved in all 35 cases had been given epidural steroid injections, Park said.
Aside from the 25 cases in Tennessee, there have been four reported cases in Virginia, two each in Maryland and Florida, and one each in North Carolina and Indiana. Virginia and Maryland have each reported one death associated with the outbreak.
The incubation period for the fungal infection is not known, and more cases might yet be detected, although the suspect lots of the steroid are no longer being used.
Park said parts of the three lots of steroid were shipped to 23 states -- the six reporting cases, plus California, Connecticut, Georgia, Idaho, Illinois, Michigan, Minnesota, New Hampshire, Nevada, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, and West Virginia.
Symptoms include new or worsening headache, nausea, dizziness and fevers and possibly slurred speech, unsteady gait, urinary retention, weakness, and sensory deficit.
The delay between the injection and the appearance of symptoms has been between 1 and 4 weeks, Park said. The severity of symptoms has varied widely, he added.
Officials have emphasized that the condition is not contagious, unlike viral or bacterial meningitis.
Park said the outbreak came to light when Tennessee officials called the CDC on Sept. 21 with a report of a patient with meningitis that became apparent 19 days after an epidural steroid injection.
Initial cultures from the cerebrospinal fluid were negative, but later work discovered a fungus in the cerebrospinal fluid (CSF), he said.
A week later, on Sept. 28, the agency was notified of a case outside Tennessee, "possibly indicating contamination of a widely distributed medication," he said.
Healthcare personnel should take all products from the Framingham pharmacy off their shelves, Park said.
Doctors should contact all patients who got an epidural steroid injection with a drug from one of the three recalled lots to see if they are experiencing any symptoms, however mild, he added.
Patients who got other types of injections using a drug from one the three lots should also be investigated, Park said.
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