FDA Warns About Fungal Meningitis in Transplant Patient Who Received NECC Cardioplegia Solution

October 16th, 2012

FDA Warns About Fungal Meningitis in Transplant Patient Who Received NECC Cardioplegia Solution

Larry Husten, PHD

The FDA said on Monday that it had identified a transplant patient with Aspergillus fumigatus infection who received cardioplegia solution during surgery. The solution was manufactured by the New England Compounding Center (NECC), which has been at the center of a broad investigation after the deaths of at least 15 patients from fungal meningitis due to contaminated vials of methylprednisolone acetate injection.

The FDA said it had also identified a patient who may have developed meningitis from an epidural injection of another injectable steroid made by NECC, triamcinolone acetonide. The agency noted that “there may be other explanations” for the infection in the transplant patient and that it has not confirmed that the two new cases were caused by NECC products.

Out of “an abundance of caution,” the FDA recommends that patients who received any injectable drugs manufactured by NECC “should be alerted to the potential risk of infection.” The FDA said this recommendation extends to patients who received injectable ophthalmic drugs made by NECC, although no infections have been reported with these drugs. The FDA also said patients should be told about the symptoms of meningitis and instructed to immediately report if they have any of these symptoms.

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October 16th, 2012