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Handout / Reuters
The fungus Exserohilum has caused most of the infections tied to a deadly outbreak of fungal meningitis.
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.
Related stories:
- Pharmacy-made pregnancy drug under scrutiny after outbreak
- Feds find bacteria, mold at site of fungal meningitis outbreak
Leave a Comment:
We should line up the entire management team and all the scum that worked there, and give them all injections with this garbage they knowingly shipped across the country.
If that doesn't work, then charge them all with manslaughter.
But alas, no one will do time, no one will pay for this. They will simply declare bankruptcy and skate away. I saw one report where the state was trying to freeze personal accounts, but that only works when it's a surprise. Now that they have cleaned out all the accounts, liquidated any personal property what's the good of doing anything?
All that is left is karma. Perhaps all that were involved in producing these drugs in the filthy conditions they had will get some nasty disease. Something that will drag on for months and kill them slowly and in horrific pain. Just like they did to the 380+ people so far.
It's seldom that I agree with Chinese methodology, but in this case a swift public trial of the CEO followed by a public execution might just send the right message.
Menningitis is Climate influenced. Fungus. Now more than ever after Sandy are we all at risk. Severe Regulation needs to be enforced. Profit be damned. Life and health must be Americas number one priority.
The people in these industries have to Remember...they are in it to Help...not to make an absurd profit.
r u a freaking commy, where in the world would you come up with such BULL$HIT
This is part and parcel of the "Corporations are people too my friend" school of management thought. Profits first, all the little nagging regulations second.
Let's hope the company isn't an LLC because if it is those 14000 are screwed.
I am shocked that we have been thrown into this horrible night mare. as a person who will not let a drug be put into my body by a needle. i have one question, where in the hell is our famous F.D.A. are these people americans, do these criminals have a citizenship in another country. to me this is a pure sign of a crime against the people of the US. the fabulous media is on this band wagon of reporting this horror, but we have yet to know who is the people that are behind this company. i looked up to see who owned this company and the only name that keeps coming up is warren buffet as major stockholder. i need and want more info as to the people that own, run and stockholders
Put the sneaky weasels and their cohorts in prison for a long time, and this includes all the career bureaucrats and executives of professional organizations who were supposed to be monitoring these companies, really . . .
Really! :-o
Here is something to think about.
If Gingrich hadn't deregulated the oversight in the 90s and the goper thugs in Congress hadn't defunded the oversight in the 00s maybe someone would have been around to inspect this crap.
Right-wingers, you can't expect anything other than a crap shoot if no one is there to protect your interests. Societies don't exist in the chaos and lawlessness you buffoons apparently want to live in. This isn't the stone age and you have to get your roads, utilities and safety net from somewhere. John Wayne ain't gonna build your sewers.
Idiots, all of you buffoons.
So,why don't they make it easy and tell us what they didn't find?
Cleanliness
So much for the "Made in the USA" motto meaning diddley squat. It seems as though we're no better than the dam Chinese! Hang these guys for once and that'll tell the whole world that Made in the USA actually means something again. And yeah, while you're at it, hang all the republicans that allowed this country to go down the drain, literally, down the drain. If it weren't for the last 15 years of Republican control of Congress (or part of it) and Bush hisself, then we wouldn't be in such a mess. From the economy to the drugs we ingest....IT'S ALL GEORGE W. BUSHES FAULT!
Did this company have a board of directors?!? If so, they have a legal resonsibility to ensure the company is acting in accordance with laws and regulations. The oversight sounds so absent, they may actually be persoanlly liable for the companies actions.
Actually there's pretty good evidence they played an active role. Consider some of the problems: Autoclaves not operating for long enough, air conditioning being shut down in clean rooms overnight, leaky boilers next to clean rooms, testing for sterility but shipping before the test results are back, not filling in a patient ID # on each vial, and producing bulk quantities against their license.
Some of these things, taken individually, could be a rouge technician or a sloppy manager. Taken together it is 100% clear the entire organization is deliberately mismanaged. You can't have operations large enough to produce bulk quantities without the CFO, COO, and CEO knowing about it. The capital investment is just too big.
R-money...The Great Deregulator..and the Governor of Mass. does not believe in oversight or regulation. He believes companys and corporations can regulate themselves! NOT..and here is perfect proof that his beliefs are a bunch of BS. Why is nobody of consequence pointing this fact out to the general public? This company in Framingham, Mass. has deliberately and knowingly shipped contaminated drugs to at least 19 states. People are dying! Thousands are sickened and may still die. This company put profits before all else! This is what happens when there is NO oversight.
Worse yet, the company received a warning letter from the FDA in the middle of Romney's term. Nothing screams "red flag" like a warning letter from the FDA.
There is a petition to request greater regulation of drug compounding
facilities on the ”We the People” WhiteHouse.gov website. Compounding facilities need greater
regulation to meet the medical standards that warrant Americans’ trust in
healthcare. You can view and sign the petition here (you may have to cut and paste in your browser):
I would not be surprised if this company, in the USA, is in fact owned and managed by Chinese. We all know their track record with poisons for us, our kids, and our pets.
Included in the 20% or so of positions with which I DO NOT agree with the Libertarian party is the desire to deregulate industry. While I agree with them wholeheartedly in terms of the Individual's rights, I cannot get on board with letting companies such as this run amok over the health of human beings. A company is not a person, they are not entitled to rights.
That is why I will be voting for Rocky Anderson. Though he is not as big on individual liberty as the Libertarians, he also understands that the foxes will not keep themselves in check around the henhouse.
Since Illegal aliens are protected from and allowed to ignore the laws of the USA why should anyone else be concerned with them? This is what comes of a government that is more interested in what goes on across the ocean than what happens in this country. Next week vote every incumbent out. They have proven repeatedly that the USA is not high on their list of priorities. Replace them and perhaps we will get representatives who are concerned with our country first. Vote.