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FDA finds more bad drugs from Mass. company

12:47 PM, Nov 22, 2012   |    comments
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By Tom Wilemon, The (Nashville) Tennessean

NASHVILLE -- Testing by the FDA on steroid medications produced by a Massachusetts company linked to a national outbreak of fungal meningitis has found more contaminants in additional drugs.

The U.S. Food and Drug Administration has updated its list of lot numbers for contaminated drugs produced by New England Compounding Center after finding unknown fungal growths and bacteria in triamcinolone and betamethasone.

The outbreak of fungal meningitis and other infections has sickened 490 people, with 34 deaths.

Those illnesses were linked to preservative-free methylprednisolone acetate administered in epidurals or joint injections as a treatment for pain. However, the other two steroids, betamethasone or triamcinolone, have not been identified with infections in the ongoing probe of the outbreak. The U.S. Centers for Disease Control and Prevention is "unaware of infections among patients that can be definitively linked to exposure to these drugs," said Curtis Allen, a spokesman for the CDC.

The bacterial contaminants in betamethasone and triamcinolone are not recognized pathogens, said Dr. William Schaffner, an infectious disease expert with Vanderbilt University.

"They are environmental bacteria that are present just everywhere in the environment," Schaffner said. "You can find them on inanimate surfaces. You can find them out in the soil and the like. They obviously should not be in these medications. Could this bacteria, however, if inoculated produce an infection? On occasion they could. But they are not what we call professional pathogens."

However, he noted that the fungus Exserohilum rostratum had never been known to cause meningitis until it was introduced into patients' spinal cavities.

"There is obviously a potential, but fortunately I would call them (the bacteria) a very low-grade hazard," Schaffner said.

The FDA previously said in an inspection report that foreign substances were found on heating and cooling vent louvers behind a piece of equipment used to make bulk drug suspensions of preservative-free methylprednisolone and triamcinolone at New England Compounding Center.

The Tennessee Department of Health lab found evidence of contamination in both betamethasone and triamcinolone last month, but the state agency said it could not rule out the prospect of the contamination having occurred in its testing center.

Inspections of the New England Compounding Center by the FDA and the Massachusetts Board of Pharmacy found several possible sources for the contamination, including leaking water, uncontrolled temperature and dirty conditions. A leaking boiler left puddles on the floor, equipment was soiled with greenish-yellow residue and air conditioning was turned off at night, according to the inspection reports.

The (Nashville) Tennessean

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