Fifteen people have died of fungal meningitis from a contaminated steroid lot, and nineteen more cases related to contaminated steroid injections were reported this week, bringing the national total to 233 in 15 states. The Centers for Disease Control and Prevention said the newly-reported cases are in nine states: Florida, 2; Indiana, 2; Maryland, 1; Michigan, 1; New Hampshire, 2; New Jersey, 2; Ohio, 2; Tennessee, 6; Virginia, 1. Twenty-five of the meningitis cases were previously reported in Tennessee, where more than 900 residents received the drug in the past three months. Other cases have been reported from North Carolina. All are linked to steroid injections sold by the now-closed New England Compounding Center (NECC) in Framingham, Mass. (USA Today story)
The outbreak of aspergillus (or fungal) meningitis, a rare and serious form of meningitis, has been linked to the spinal steroid injections given 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.
“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.”
About 75 clinics in two dozen states that received the recalled lots have been instructed to notify all affected patients.
“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. Park added that most cases occurred in older adults with back pain but who were otherwise healthy.
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 more subtle than those of bacterial meningitis. Symptoms can also take nearly a month to manifest. The inflammatory disease can cause permanent neurological damage and death if left untreated.
“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.”
Detection & Treatment
The disease is diagnosed with a lumbar puncture to draw and inspect cerebrospinal fluid. Treatment involves intravenous doses of anti-fungal medications that can take months and require a hospital stay.
Unlike bacterial and viral meningitis, fungal meningitis is not transmitted from person to person. Only people who received the steroid injections are thought to be at risk.
The FDA, however, has advised health providers to stop using any product made by the New England Compounding Center during the investigation.
“We’re urging clinics to discontinue use of all products from the New England Compounding Center,” said Dr. Bernstein, adding that purchase records can be used to identify the suspect products. “Given the severity, we believe this precaution is warranted.”
Larger Questions Lurk
The outbreak has raised questions about the safety of drugs from state-regulated compounding pharmacies, which combine drug ingredients for customized medications. The U.S. Food and Drug Administration warned the New England Compounding Center in 2006 that repackaging drugs opens the door to contamination.
“The moment a sterile container is opened and manipulated, a quality standard (sterility) is destroyed and previous studies supporting the standard are compromised and are no longer valid,” the agency wrote in a letter to the pharmacy.
“The agency did issue a warning letter to the pharmacy in 2006, but it didn’t address compounding problems that are at issue today,” said Kathy Anderson, acting director of the FDA’s Office of Unapproved Drugs and Labeling Compliance.
As the tally from the deadly outbreak rose last week, health officials identified medical clinics across the country that received steroid lots for back pain now linked to the illnesses. Authorities took the step to help identify everyone who may have gotten sick — or may still get sick — in the outbreak.
“All patients who may have received these medications need to be tracked down immediately,” said Dr. Benjamin Park of the Centers for Disease Control and Prevention.
If you or a loved one has suffered from acute symptoms of Aspergillus Meningitis due to being treated with tainted steroid injections of the drug Methylprednisolone Acetate, call Matthews & Associates for a free legal consultation today.