Contamination found in 2 more New England Compounding Center products
Federal regulators said Thursday they found bacterial contamination in two more drugs produced by the Framingham compounding pharmacy that made the injectable steroids blamed for the national meningitis outbreak.
The additional New England Compounding Center products are preservative-free betamethasone, a steroid used to ease back pain, and cardioplegia solution, a medication used in heart surgery.
The US Food and Drug Administration and the Centers for Disease Control and Prevention identified bacteria in three separate lots of betamethasone and in a single lot of cardioplegia solution. They did not say how many doses were in each lot.
A fungus previously found in another steroid the company makes, preservative-free methylprednisolone acetate, is believed to have infected 386 patients with fungal meningitis and joint infections and killed 28. The fungus has been found in two of the three lots of the drug implicated in the outbreak, and testing of the third lot is ongoing.
“The clinical significance of these (new) results is not known,’’ the FDA said in a statement posted on its website. As of Thursday, the CDC had not received reports of laboratory-confirmed cases of bacterial infection in patients linked to betamethasone or cardioplegia solution from New England Compounding, the FDA said.
But the findings “reinforce the FDA’s concern about the lack of sterility in products produced at NECC’s compounding facility and serve to underscore that hospitals, clinics, and health care providers should not use any NECC-supplied products,’’ the agency said.
Federal officials previously said they were investigating whether contaminated products caused fungal infections in two patients who were treated with cardioplegia and another drug made by New England Compounding. On Thursday, the FDA said it was awaiting the results of tests for fungal contamination in betamethasone and cardioplegia solution.
All the company’s products have been recalled, and the company has ceased operations.Liz Kowalczyk can be reached at email@example.com.