Saturday, October 6, 2012


Date: Fri 5 Oct 2012

Source: NBC News, Associated Press (AP) report [edited]

The potential scope of the meningitis outbreak that has killed at least 5 people widened dramatically Thu 4 Oct 2012, as health officials warned that hundreds, perhaps thousands, of patients who got steroid back injections in 23 states could be at risk. Clinics and medical centers rushed to contact patients who may have received the apparently fungus-contaminated shots and the 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 injections, or even whether everyone who got one will get sick.

So far, 35 people in 6 states -- Tennessee (25), Virginia (4), Maryland (2), Florida (2), North Carolina (1) and Indiana (1) -- have contracted fungal meningitis, and 5 of them have died, according to the CDC. 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 [NECC] of Framingham, MA, has recalled 3 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 2012 and September 2012, federal health officials said. Several hundred of the vials, maybe more, have been returned unused, a Massachusetts official said.

But many other vials were used. At a clinic in Evansville, Indiana, more than 500 patients got injections from the suspect lots, officials said. At 2 clinics in Tennessee, more than 900 patients, perhaps many more, did.

The investigation began about 2 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 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.

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. The common mold _Aspergillus_ was cultured from 5 patients, the CDC said Thursday [4 Oct 2012].

The New England company is what is known as a compounding pharmacy. These pharmacies custom-mix solutions, creams, and other medications in doses or in forms that generally aren't commercially available. Other compounding pharmacies have been blamed in recent years for serious and sometimes deadly outbreaks caused by contaminated medicines. Compounding pharmacies are not regulated as closely as drug manufacturers, and their products are not subject to FDA approval.

A national shortage of many drugs has forced doctors to seek custom-made alternatives from compounding pharmacies. The New England company at the center of the outbreak makes dozens of other medical products, state officials said. But neither the company nor health officials would identify them.

The company said in a statement Thursday [4 Oct 2012] that despite the FDA warning, "there is no indication of any potential issues with other products." It called the deaths and illnesses tragic and added: "The thoughts and prayers of everyone employed by NECC are with those who have been affected."

A 2011 state inspection of the Framingham facility gave the business a clean bill of health.

[Byline: Mike Stobbe]

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