Sat, Oct 06, 2012 - Page 7 News List

Tainted medication puts hundreds at risk of meningitis

HIDDEN KILLER:The firm behind the manufacture of a batch of infected pain-killing drugs has shut down its operations as investigations continue

AP, NEW YORK

The potential scope of the meningitis outbreak that has killed at least five people widened on Thursday as health officials warned that hundreds, perhaps thousands, of patients who got steroid back injections in 23 US states could be at risk.

Clinics and medical centers rushed to contact patients who may have received the apparently fungus-contaminated shots while the Food and Drug Administration (FDA) urged doctors not to use any products at all from the Massachusetts pharmacy that supplied the suspect steroid solution.

It is not clear how many patients received tainted medication, or if those who did will get sick.

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.

In an alarming indication the outbreak could get a lot bigger, Massachusetts health officials said the pharmacy involved, the New England Compounding Center of Framingham, Massachusetts, has recalled three lots consisting of a total of 17,676 single-dose vials of the steroid, preservative-free methylprednisolone acetate.

An unknown number of those vials reached 75 clinics and other facilities in 23 states between July and last month, federal health officials said. Several hundred vials have been returned unused, one Massachusetts official said.

However, many others were used. At one clinic in Evansville, Indiana, more than 500 patients got shots from the suspect lots, officials said, while a Tennessee clinic gave more than 900 patients shots.

The investigation began about two weeks ago after a case was diagnosed in Tennessee. 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.

Investigators this week found contamination in a sealed vial of the steroid at the New England company, according to FDA officials. Tests are under way to determine if it is the same fungus blamed in the outbreak.

The firm has shut 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.

Tennessee has by far the most cases with 25, including three deaths. Deaths have also been reported in Virginia and Maryland.

Meningitis causes inflammation of brain lining 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.

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