Dec. 3, 2012 at 9:35 PM ET
More contamination has been confirmed in additional vials of drugs produced by the Massachusetts compounding pharmacy blamed for the ongoing outbreak of fungal infections that have sickened hundreds and led to 36 deaths.
But federal health officials said there’s no evidence to date that the new drugs have sparked any additional outbreaks of fungal meningitis or other illnesses.
New laboratory results show bacteria and fungi present in unopened vials of three drugs different from the injection epidural steroids produced by the New England Compounding Center of Framingham, Mass., and already implicated in 541 infections, federal health officials said in a health alert released late Monday.
The contaminants include a dozen types of Bacillus bacteria and fungi species including two types of Aspergillus, plus Cladosporium and Penicillum. Some of those organisms, including Aspergillus fumigatus, are known to cause human disease, the Centers for Disease Control and Prevention said.
The federal Food and Drug Administration had previously found several types of Bacillus bacteria in two additional drugs made by NECC. The three drugs confirmed to be contaminated include injection betamethasone, a steroid to treat inflammation; triamcinolone, which treats severe itching; and cardioplegia solution, which is used in heart surgery, the CDC said.
Some patients have reported illnesses after receiving the drugs, the CDC said. Some patients have even developed inflammation of the central nervous system membranes after receiving the drugs.
However, health officials said they have received no laboratory-confirmed reports of bacterial or fungal meningitis, spinal or para-spinal infections caused by those products. The original infections were linked to tainted methylprednisolone acetate injections.
“Data do not, at this time, support evidence of an outbreak of infections linked to usage of non-methylprednisolone NECC products,” the agency said.
Because there’s a chance the tainted drugs could cause illness, CDC officials urged doctors and other health care providers to be alert for signs of fungal infection in patients who received the additional medications.
About 14,000 people received the tainted epidural steroids, which have been linked to infections in patients in 19 states. About two-thirds of new infections still being reported are not fungal meningitis, but rather abscesses, a condition called arachnoiditis and other infections.
Inspections at the now-shuttered NECC manufacturing site found evidence of environmental contamination -- including mold and other problems -- dating back to January.