3 Ohioans confirmed with rare meningitis linked to tainted steroid injections


MENINGITIS U.S. OUTBREAK

Federal health officials reported Thursday 14 people have died from fungal meningitis linked to an injectable steroid and 170 people have developed infections. Here are national totals:

Florida: 7 cases, 2 deaths

Idaho: 1 case, no deaths

Indiana: 21 cases, 1 death

Maryland: 13 cases, 1 death

Michigan: 39 cases, 3 deaths

Minnesota: 3 cases, no deaths

New Jersey: 2 cases, no deaths

North Carolina: 2 cases, no deaths

Ohio: 3 cases, no deaths

Tennessee: 49 cases, 6 deaths

Virginia: 30 cases, 1 death

SOURCES: The Centers for Disease Control and Prevention and the Food and Drug Administration

MENINGITIS U.S OUTBREAK

Federal health officials reported Thursday 14 people have died from fungal meningitis linked to an injectable steroid and 170 people have developed infections. Here are national totals:

STATE CASE COUNT DEATHS
Florida 7 2
Idaho 1 0
Indiana 21 1
Maryland 13 1
Michigan 39 3
Minnesota 3 0
New Jersey 2 0
North Carolina 2 0
Ohio 3 0
Tennessee 49 6
Virginia 30 1
TOTALS 170 14

Two more Ohioans have become the latest fungal meningitis victims after receiving tainted steroid injections produced at a Massachusetts pharmacy.

The Ohio Department of Health Thursday reported two women, a 39-year-old from Morrow County and a 40-year-old from Crawford County, developed the rare brain infection after receiving the steroid injections. State health officials announced Saturday a 65-year-old man, identified Thursday as living in Hamilton County, had also developed the infection. None of their medical conditions have been released.

The steroid is normally injected in and around the spine and in between joints to treat pain.

Nationally, 170 cases and 14 death have been reported in 11 states, and federal health officials announced Thursday the outbreak is the first linked to a common fungus usually found in soil and on plants and grasses.

A Michigan patient who received an injection of the drug has developed a joint infection, but it is not yet known if a fungus is to blame for the infection, the Centers for Disease Control and Prevention reported.

The CDC and the Food and Drug Administration are investigating the outbreak, linked to the steroid manufactured by the New England Compounding Center in Framingham, Mass. NECC ceased operations Oct. 3, and has recalled all of its products. It appears NECC violated state law governing how compounding pharmacies are supposed to work, according to Dr. Madeleine Biondolillo, director of the Massachusetts Department of Public Health’s Bureau of Health Care Safety and Quality. She said NECC is not supposed to do large-scale production like a drug manufacturer, but to produce medication for patient-specific prescriptions.

State and federal inspectors said they found troubling signs at the company’s facility.

Pharmaceutical manufacturing is an exact science, requiring strict standards and practices, said Deborah M. Autor, the FDA’s deputy commissioner for global regulatory operations and policy. But, she said inspectors found fungus growing in “multiple” steel vials used to prepare the injection at the Framingham facility and in vials of the steroid collected from hospitals, clinics and doctors offices around the country. Products used in association with administering the steroid were also checked, but tested negative for fungi, she said.

Autor said a second Massachusetts pharmacy, Ameridose LLC in Westborough, is also under investigation by the FDA and the Massachusetts State Board of Pharmacy. Ameridose has some shared ownership with NECC and has also temporarily ceased operations, Autor said. She added state and federal officials are inspecting the second facility, its records and policies.

So far, there is no evidence of contamination of any of Ameridose’s products, and no recall of their products has been requested, Biondolillo said.

Second fungus discovered

Early in the outbreak, health officials believed the common fungus aspergillus was to blame for the outbreak. But investigators in Virginia have identified a second fungus species, exserohilum,that has been linked so far to 10 meningitis infections, while aspergillus has been linked to one, said Dr. Todd Weber, incident manager for the meningitis outbreak and chief of the Prevention and Response Branch in the CDC’s Division of Healthcare Quality Promotion.

All fungal meningitis is “historically very rare,” Weber said. “Exserohilum has not been seen previously as a cause of fungal meningitis. This is new territory for public health and the clinical community.”

The discovery means experts are reviewing and revising treatment guidelines for people who develop meningitis linked to the steroid, Weber said.

In most cases, patients started getting sick between a week and a month after receiving the injections, but fungal meningitis can develop very slowly, he said. “We need to be vigilant for at least several months” in looking for new cases among patients who received the steroids, Weber said, and patients who develop symptoms should contact their doctors immediately. “Given the severity of fungal meningitis, time is of the essence in getting treatment.”

Fungi can be difficult to detect, so people who develop meningitis after receiving the steroid should be given anti-fungal drugs as a precaution, he said. “Patients and their clinicians should not assume that fungal testing that is negative means there’s no fungal infection,” he said.

The outbreak highlights the need for stronger federal regulations of compounding pharmacies, which face less oversight than traditional pharmaceutical manufacturers, Autor and Biondolillo said.

“We urge Congress to act quickly to address the need for new laws to fill in the regulatory gap,” Biondolillo said.

In Ohio, four pain clinics — one in Cincinnati, one in Dublin and two in Marion — received from the pharmacy company the steroid, methylprednisolone acetate. Clinics reported 422 patients received the drug, and health officials have reached 419 of them to warn them of the meningitis risk. Officials said outreach is ongoing to make contact with the remaining patients.

“This outreach and contact with health care providers needs to continue even if the patient is feeling well during the initial conversation,” said Dr. Ted Wymyslo, director of the Ohio Department of Health. “Because of the rare nature of this infection, no one is sure of the incubation period; we don’t know how long after an injection it is safe to say you won’t get sick.”

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