Rare Fungal Meningitis Outbreak in Nine States: 7 Dead; 91 Cases Reported

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Samstwitch

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Rare Fungal Meningitis Outbreak in Nine States: 7 Dead; 91 Cases Reported

October 7, 2012 - Health officials reported 27 new cases of a rare fungal meningitis outbreak today that has killed seven people and sickened a total of 91 across nine states.

The outbreak of aspergillus meningitis has been linked to spinal steroid injections, a common treatment for back pain. A sealed vial of the steroid, called methylprednisolone acetate, was found to contain fungus, according to the U.S. Food and Drug Administration.

The states with reported cases are: Tennessee, Florida, North Carolina, Indiana, Michigan, Virginia, Maryland, Minnesota and Ohio.

"FDA is in the process of further identifying the fungal contaminate," said Dr. Ilisa Bernstein, acting director of the FDA's Center for Drug Evaluation and Research Office of Compliance. "Our investigation into the source of this outbreak is still ongoing."

The steroid came from the New England Compounding Center in Framingham, Mass., a specialty pharmacy that has recalled three lots of the drug and shut down operations. Calls to the pharmacy were not immediately returned and its website is down.

Roughly 75 clinics in 23 states that received the recalled lots have been instructed to notify all affected patients.

Stephan Savoia/AP PhotoA "No Soliciting" sign hangs on the door of... View Full Size Stephan Savoia/AP PhotoA "No Soliciting" sign hangs on the door of pharmaceutical manufacturer New England Compounding Center in Framingham, Mass., Oct. 4, 2012.

"If patients are concerned, they should contact their physician to find out if they received a medicine from one of these lots," said Dr. Benjamin Park of the U.S. Centers for Disease Control and Prevention, adding that most of the cases occurred in older adults who were healthy aside from back pain.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea and slurred speech, are subtler than those of bacterial meningitis and can take nearly a month to appear. Left untreated, the inflammatory disease can cause permanent neurological damage and death.

"Fungal meningitis in general is rare. But aspergillus meningitis -- the kind we're talking about here -- is super rare and very serious," said Dr. William Schaffner, president of the National Foundation for Infectious Diseases and chairman of preventive medicine at Vanderbilt University Medical Center in Nashville, Tenn. "There's no such thing as mild aspergillus meningitis."

The disease is diagnosed with a lumbar puncture, 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.

"Treatment could be prolonged, possibly on the order of months," said Park, adding that the IV treatment would require a hospital stay.

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

The FDA has, however, advised health providers to stop using any product made by the New England Compounding Center during the investigation.
 
More than 200 diagnosed in fungal meningitis outbreak

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Centers for Disease Control and Prevention

The two molds that have caused meningitis in 203 people and killed 15 of them. Left is Aspergillus; on the right is Exserohilum
By Maggie Fox, NBC News

More than 200 people in 14 states have either died or shown symptoms in an outbreak of rare fungal meningitis linked to contaminated pain injections, federal health officials said Sunday. Fifteen people have died.

The Centers for Disease Control and Prevention said 203 people had meningitis, while two had infections in their joints.

The CDC has also published its first case report of the outbreak, which began when a Tennessee doctor diagnosed a patient with fungal meningitis on Sept. 18, nearly six weeks after getting a steroid injection for back pain.

The CDC says 26 of the patients have a confirmed fungal infection, and all but one are infected with a type of black mold called Exserohilum. It’s never been known to cause meningitis before, although it’s common in the environment and can cause sinus and eye infections. One patient has Aspergillus, another fungus that occasionally can cause meningitis if injected into the spine, as well as other infections.

Both grow slowly and don’t cause the classic symptoms of meningitis. “Early in this outbreak, many patients with meningitis had only a few mild symptoms,” the CDC and state health offficials say in their report.

Worse, treatment can last months and requires infusions of two strong antifungal drugs, the CDC says. Right now, no one knows how long patients will have to be treated, and the drugs themselves can cause severe side effects such as kidney damage. As many as 14,000 patients may have been given the tainted steroids.

“Early identification and treatment of patients with fungal infections might reduce the risk for serious complications, such as stroke or death,” CDC says.

Meningitis is an inflammation of the spinal cord or the membrane surrounding the brain. It's extremely serious when caused by bacteria; viruses can also cause meningitis. Fungi and parasites cause it more rarely. Most of the patients in this outbreak have complained of headaches.

"FDA urges patients who believe they received an injection or other product compounded by NECC to remain vigilant for the signs and symptoms of infection, including meningitis. The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status," the Food and Drug Administration said in a statement.

State and federal health officials are trying to find out how and why a Massachusetts pharmacy, the New England Compounding Center, managed to distribute so many vials of the steroid, called methylprednisolone. It can be injected into the spine or joints such as the knee or ankle to treat pain.

Massachusetts state health authorities say it appears NECC broke regulations in distributing the high volume of drugs. All of the cases so far have been linked to three affected batches of the steroid, although all of NECC’s products have been recalled.

A sister company, Ameridose, is also being investigated. "Based on the business relationship between NECC and Ameridose, FDA and the Massachusetts Board of Pharmacy launched a joint inspection at the Ameridose facility in Westborough, Massachusetts on October 10, 2012," the FDA said in a statement.

"As part of our efforts to protect the public health, FDA is investigating whether certain aspects of compounding practices and facility conditions observed at NECC may be present at the Ameridose facility. FDA will review whether Ameridose has procedures and facilities necessary to safely produce and provide sterile drug products. At this time, there is no known contamination of products produced by Ameridose."
 

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