Nov. 1, 2012 at 4:06 PM ET
Contamination has been found in two additional drugs made by the pharmacy tied to a deadly outbreak of fungal meningitis, federal health officials said Thursday.
Ten different kinds of bacteria were detected in the drugs, including eight in separate lots of betamethasone, a steroid injection used to relieve severe itching, and two more types of bacteria found in a batch of cardioplegia solution used to stop the heart during surgery, the Food and Drug Administration reported.
That’s in addition to five kinds of fungi that now have been detected in people or products linked to the New England Compounding Center, the Framingham, Mass., firm at the center of the outbreak.
As of Thursday, the outbreak has caused 377 cases of fungal meningitis, stroke caused by fungal meningitis or other central nervous system infections, plus nine joint infections, for a total of 386 cases in 19 states, according to the Centers for Disease Control and Prevention. At least 28 people have died.
FDA officials also said they're testing the two additional drugs from NECC for fungal contamination and expect those results soon.
"The presence of additional microbial organisms and/or fungus in these products cannot be ruled out at this time," FDA officials said in a statement.
One lot of preservative-free betamethasone was contaminated with paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex and Lysinibacillus sp. Another lot was tainted with Bacillus niabensis and Bacillus circulans, while a third lot held Bacillus lentus and Bacillus circulans. Lab tests found Bacillus halmapalus and Brevibacillus choshinens in the cardioplegia solution.
No infections tied to the bacterial contamination of the betamethasone or the cardioplegia solution have been detected, officials said.
The FDA released the results of new laboratory tests the day after the CDC released lab results that found two new types of fungi in the contaminated injection steroids linked to infections in the ongoing outbreak.
CDC found that the same fungus that caused most of the meningitis and joint infections in outbreak was also found in unopened vials of the drug, methylprednisolone.
All but two of 54 infections confirmed by CDC labs as of Oct. 22 were caused by Exserohilum rostrum, a fungus typically found in the environment. That same fungus was found in two lots of unopened vials of methylprednisolone acetate recalled by the now-shuttered New England Compounding Center on Sept. 26.
The remaining two CDC lab-confirmed infections were caused by the fungi Aspergillus and Cladosproium, CDC has previously reported.
In addition, CDC says it has detected two more fungi, Rhodotorula larynges and Rhizopus stolonifer, in unopened vials of the drugs. Those fungi are not known to cause human infections because they can’t grow at body temperature, the agency said.
The CDC lab tests don’t reflect the total case count because laboratory methods used to detect fungal meningitis are not highly sensitive, the agency said. Many patients with fungal infections can actually have negative laboratory results.
State and federal inspections have revealed significant problems with sterility at NECC’s site. The company itself documented mold and bacteria throughout its clean rooms dating from January through September, an FDA inspection report showed.
All products from NECC have been recalled and the company’s pharmacy license has been permanently revoked. In addition, unexpired drugs produced by a sister company, Ameridose LLC, were recalled this week after FDA inspectors raised questions about problems with sterility.
Nearly 14,000 people in 23 states may have received injections of the tainted drugs. The greatest risk of stroke, death or other problems is in the first six weeks after the injections, the CDC has said. For most patients who got the shots, that means that the danger will be largely over by next week, health officials have said.