Wider Meningitis Risk From Tainted Drugs Feared

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The New York Times
Tuesday, October 16, 2012

Wider Meningitis Risk From Tainted Drugs Feared

By DENISE GRADY and SABRINA TAVERNISE

Health officials are warning that more people may be at risk from contaminated drugs made by a Massachusetts company linked to a growing meningitis outbreak.

The Food and Drug Administration reported on Monday that the company’s products may have also caused other types of infections in patients who have had eye operations or open-heart surgery.

The new warning is based on only two cases, and it was not known for sure whether the company’s drugs had caused the infections. Officials did not say how many people may be at risk, but the number is potentially significant, and a statement from the agency warned doctors, “The F.D.A. recognizes that some health care professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of today’s announcement.”

The company, the New England Compounding Center in Framingham, Mass., has already been linked to a meningitis outbreak that has killed 15 patients and infected 199 others in 15 states. The drug implicated in that outbreak is methylprednisolone acetate, a steroid used in spinal injections for back and neck pain. The drug is believed to have been contaminated with a fungus called Exserohilum, which causes a type of meningitis that is severe but not contagious.

Now, several other drugs made by the company are also possible suspects in infections. A heart-transplant patient exposed to a product that is used during open-heart surgery developed a chest infection with a different fungus, Aspergillus, the Food and Drug Adminstration said. The product is a cardioplegic solution, which is chilled and poured into the opened chest to stop the heart while surgeons work on it. Such solutions have caused problems in the past, according to the F.D.A., which reported that it issued a warning letter in 2006 to a firm that had produced a solution that caused fatal infections in three heart-surgery patients.

The agency emphasized that the heart case was still being investigated, and that it was possible that the infection had come from a source other than the cardioplegic solution. A second heart-surgery patient who had an Aspergillus infection and was initially reported to have received a solution made by the New England Compounding Center had been treated with solution made by another company.

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