Meningitis Outbreak: 368 Cases, 29 Deaths

An outbreak linked to tainted steroids has sickened 368 people in 19 states.

BySydney Lupkin
October 31, 2012, 2:35 PM

Oct. 31, 2012— -- Another person has died from a fungal meningitis outbreak tied to tainted steroid injections, bringing the total death toll to 29, health officials reported today.

The U.S. Centers for Disease Control and Prevention has increased the tally of cases to 377. That's 368 cases of fungal meningitis and nine joint infections. Rhode Island became the 18th state affected by the outbreak on Monday.

In New Jersey, the state hit hardest by Sandy's destructive winds and flooding, no new cases were reported, state spokesman Dan Emmer said.

Although Palisades Medical Center had to evacuate after its back-up electricity generator failed, it is unlikely that any of the state's 18 meningitis patients were there, said a hospital official at Hackensack University Medical Center, which received many of the evacuees.

The outbreak has been linked to contaminated vials of methylprednisolone acetate, an injectable steroid used to treat back and joint pain. Sealed vials of the steroid, made by the New England Compounding Center in Framingham, Mass., contained exserohilum rostratum, a fungus found in soil and plants.

It's unclear how the fungus landed in the sealed vials, but a quarter of the steroid vials in a bin tested at the New England Compounding Center contained "greenish black foreign matter," according to an FDA form released Friday. The form went on to identify several clean rooms -- where sterile products are produced -- that had either mold or bacterial overgrowths.

Ameridose, NECC's sister company, voluntarily recalled all drugs today, citing sterility concerns, according to the FDA. Neither Ameridose nor the FDA have received any complaints or identified any impurities in the drugs.

Today, the Boston Globe reported that it obtained Quality Assurance Report Cards that NECC sent to its customers weeks before it was forced to shut down operations and recall all drugs because of the outbreak. The cards touted the facility's cleanliness, contradicting what investigators found.

Although the Massachusetts Board of Pharmacy hired an Illinois-based firm, Pharmacy Support, Inc., to review NECC's operations in 2006, the firm's founder was convicted and imprisoned for fraud after a sterilizer he marketed was linked to blinding patients, the Globe reported.

State pharmacy boards oversee compounding pharmacies, unlike drug manufacturers, which are regulated by the Food and Drug Administration.

The Massachusetts Board of Pharmacy began surprise inspections of compounding pharmacies in mid-October, following the meningitis outbreak. It shut down Infusion Resource in Waltham on Monday as a result.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis -- including headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, and redness or swelling at the injection site -- can take more than a month to appear.

The longest duration from the time of injection to the onset of symptoms in the current outbreak is 42 days, according to the CDC's Dr. Benjamin Park.

"But we want to emphasize that we don't know what the longest will be," he added, stressing that patients who received injections of the recalled drug should stay attuned to the subtle symptoms "for months."

Fungal meningitis is diagnosed through a spinal tap, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

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