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Clinics rush to warn patients of tainted steroid
NEW YORK — Health providers are scrambling to notify patients in nearly two dozen states that the routine steroid injections they received for back pain in recent months may have been contaminated with a deadly fungal meningitis.
It became apparent Thursday that hundreds, and perhaps thousands, of people who got the shots between July and September could be at risk after officials revealed that a tainted steroid suspected to have caused a meningitis outbreak in the South had made its way to 75 clinics in 23 states.
So far, 35 people in six states — Tennessee, Virginia, Maryland, Florida, North Carolina and Indiana — have contracted fungal meningitis, and five of them have died, according to the Centers for Disease Control and Prevention. All had received steroid shots for back pain, a highly common treatment.
It is not clear how many patients received tainted injections, or even whether everyone who got one will get sick. The time from infection to onset of symptoms is anywhere from a few days to a month, so the number of people stricken could rise.
The pharmacy involved, the New England Compounding Center of Framingham, Mass., has recalled three lots consisting of a total of 17,676 single-dose vials of the steroid, preservative-free methylprednisolone acetate, Massachusetts health officials said.
Investigators this week found contamination in a sealed vial of the steroid at the company, FDA officials said. Tests are under way to determine if it is the same fungus blamed in the outbreak.
Several hundred of the vials, maybe more, have been returned unused, but many others were used. At one clinic in Evansville, Ind., more than 500 patients received shots from the suspect lots, officials said. At two clinics in Tennessee, more than 900 patients — perhaps many more — did.
The company has shut down operations and said it is working with regulators to identify the source of the infection.
“Out of an abundance of caution, we advise all health care practitioners not to use any product” from the company, said Ilisa Bernstein, director of compliance for the FDA's Center for Drug Evaluation and Research.
Massachusetts health officials said NECC has a pending complaint against it from this year, related to the potency of a medication used in eye surgery. It appears unrelated to the current outbreak, said Dr. Madeleine Biondolillo, director of the state’s Bureau of Healthcare Safety.
Biondolillo said two prior complaints, including one for sterile compounding procedures, were both resolved in 2006. The pharmacy was inspected and cleared by the state Department of Public Health last year after relocating its operations on the same site, she said.
The first known case in the meningitis outbreak was diagnosed about two weeks ago in Tennessee, which still has by far the most cases with 25, including three deaths. Deaths have also been reported in Virginia and Maryland.
Meningitis is an inflammation of the lining of the brain and spinal cord. Symptoms include severe headache, nausea, dizziness and fever.
The type of fungal meningitis involved is not contagious like the more common forms. It is caused by a fungus often found in leaf mold and is treated with high-dose antifungal medications, usually given intravenously in a hospital.
By Tom Fitton
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