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Author Topic: US Meningitis Outbreak Grows; (From Steroid Injections ?) 700 Cases, 51 dead  (Read 18885 times)
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« Reply #40 on: October 22, 2012, 05:24:32 PM »

http://www.boston.com/whitecoatnotes/2012/10/22/cdc-more-people-infected-with-fungal-meningitis-linked-framingham-pharmacy/1N9Gj73CdQdSyZAgvfZgYI/story.html
CDC: 12 more people infected with fungal meningitis linked to Framingham pharmacy
October 22, 2012

Twelve more people have been infected in an outbreak of fungal meningitis tied to a Framingham pharmacy, bringing the total number of cases to 294. The Centers for Disease Control and Prevention reported no new deaths when it updated its infection report Monday.

Twenty-three people have died after receiving steroid injections made at the New England Compounding Center. Three joint infections have also been tied to the steroids, which are used to treat back and joint pain.
 ::snipping2::
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« Reply #41 on: October 22, 2012, 11:03:27 PM »

http://www.washingtonpost.com/national/health-science/fda-says-1279-facilities-received-other-necc-products/2012/10/22/687ef4f0-1c7e-11e2-ad90-ba5920e56eb3_story.html
FDA: 1,279 facilities received other products from pharmacy linked to meningitis
October 22, 2012

Federal regulators are asking more than 1,200 hospitals, clinics and doctors nationwide to follow up with patients who may be at risk of infection because they received injectable medications made by the New England Compounding Center, a specialty pharmacy whose tainted steroid shots are linked to the growing fungal-meningitis outbreak.

In the Washington area, about 40 facilities, including several major hospitals and physician groups, are listed as having bought these injectable medications. Some said they were able to warn all affected patients about possible infection.

These medications are separate from the contaminated vials of the steroid drug — methylprednisolone acetate — that have been linked to the outbreak. About 14,000 people received injections of that medication. As of Monday, 294 people have received diagnoses of fungal meningitis linked to that tainted steroid, three others have joint infections, and 23 have died, according to the Centers for Disease Control and Prevention.

Federal officials say they don’t know how many more people may be at risk.

In an update posted Monday on the Web site of the Food and Drug Administration, officials urged health-care providers to follow up with any patient who received an injectable medication from the NECC that was shipped on or after May 21. It gave a list of 1,279 health-care facilities that had purchased products from the NECC, and a 261-page list of those facilities and the products they ordered. The FDA said the lists were based on information provided by the Massachusetts company and may be incomplete or inaccurate.

An FDA spokeswoman said states received the lists last week. As of Monday, the agency had received no reports of cases associated with other NECC products.
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« Reply #42 on: October 24, 2012, 03:32:11 PM »

http://abcnews.go.com/Health/Wellness/meningitis-outbreak-pharmacy-inspection-reveals-drug-safety-lapses/story?id=17552122
Meningitis Outbreak: Pharmacy Inspection Reveals Drug-Safety Lapses
October 24, 2012

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« Reply #43 on: October 24, 2012, 03:33:24 PM »

http://abcnews.go.com/Health/Wellness/meningitis-outbreak-308-cases-23-deaths/story?id=17546722
Meningitis Outbreak: 308 Cases, 23 Deaths
October 24, 2012

Ten more people have been diagnosed with fungal meningitis in an outbreak linked to tainted steroid injections, health officials reported today.

The U.S. Centers for Disease Control and Prevention has increased the tally of cases to 308: 304 cases of fungal meningitis and four cases of joint infections. One of the new cases is in Georgia, the 17th state affected by the outbreak that has killed 23 people.
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« Reply #44 on: October 25, 2012, 05:14:09 PM »

http://www.usatoday.com/story/news/nation/2012/10/25/mold-meningitis-challenge/1658259/
Unprecedented 'black mold' meningitis a challenge
October 25, 2012

Health officials aim to curb the spread of a rare and deadly form of meningitis linked to contaminated steroids.


This meningitis is hard to diagnose
328 cases, 24 deaths reported
Black mold is treatable with a drug


WASHINGTON (AP) — The black mold creeping into the spines of hundreds of people who got tainted shots for back pain marks uncharted medical territory.

Never before has this particular fungus been found to cause meningitis. It's incredibly hard to diagnose, and to kill — requiring at least three months of a treatment that can cause hallucinations. There's no good way to predict survival, or when it's safe to stop treating, or exactly how to monitor those who fear the fungus may be festering silently in their bodies.

"I don't think there is a precedent for this kind of thing," said Dr. Arjun Srinivasan of the Centers for Disease Control and Prevention. Health officials and doctors have tracked down most of the 14,000 people potentially at risk for fungal meningitis, blamed for the deaths of 24 people and sickening more than 300.

"This is definitely new territory for us," he said.
 ::snipping2::
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...and Injustice for most


« Reply #45 on: October 26, 2012, 10:34:10 AM »

1:00 AM

1,000-plus treated in Maine with products from tainted Mass. pharmacy


 By Leslie Bridgers lbridgers@pressherald.com
Staff Writer


More than 1,000 patients at Maine medical facilities have been treated with products that were recalled by a Massachusetts pharmacy after a steroid injection was linked to a meningitis outbreak that has killed 24 people and sickened hundreds more.
 


Officials from those facilities are stressing that the products they used have not been associated with the meningitis outbreak or any other illnesses, but a spokeswoman from U.S. Food and Drug Administration said Thursday that the agency is not certain the injectable steroid is the only contaminated product from New England Compounding Center.
 
State epidemiologist Dr. Stephen Sears said the tainted steroid injection was not shipped to any facilities in Maine, but 30 facilities in the state have received other products from New England Compounding Center, according to the U.S. Food and Drug Administration.
 
About of half of those facilities said Thursday that no patients have reported concerning symptoms. The other half either did not return phone calls or had no one available to comment.
 
The products from New England Compounding Center used by the Maine facilities include a vein treatment, an asthma test, numbing gels, eye drops and injections for pain, macular degeneration, lipodissolve and early-labor prevention.
 
The FDA has instructed facilities to notify patients who received an injectable product that came from the Framingham, Mass., pharmacy on or after May 21.
 
Seven facilities reported notifying more than 1,000 patients, from five at MaineGeneral Medical Center in Waterville who received injections for floppy iris procedures to about 600 patients at Central Maine Medical Center in Lewiston, who used a kit to test asthma or received an injection for pain or other conditions, according to officials at those hospitals.
 ::snipping2:: ::snipping2::

http://www.onlinesentinel.com/news/1000-treated-in-maine-with-products-from-tainted-pharmacy_2012-10-25.html
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« Reply #46 on: October 26, 2012, 09:02:13 PM »

http://www.medpagetoday.com/Neurology/GeneralNeurology/35606
Meningitis: FDA Releases NECC Report, 25 Dead
By David Pittman, Washington Correspondent, MedPage Today
Published: October 26, 2012

The New England Compounding Center (NECC) at the center of the deadly fungal meningitis outbreak found numerous instances of bacteria and mold growing in rooms meant to produce sterile products months before the current outbreak, an inspection report released by the FDA on Friday showed.

Despite those findings by its own workers, the NECC documented no corrective action to prevent contamination of its sterile drug products, the FDA said following its most recent inspection this month.

Instead, the Massachusetts-based NECC continued to produce products in the "clean rooms" before the nationwide outbreak started earlier this month. Sterile products should be produced in sterile rooms to reduce the risk of contamination.

Also on Friday, the CDC reported eight new cases of the fungal meningitis with an additional death in Tennessee, bringing the total number of deaths to 25. There are now 331 fungal meningitis cases in 18 states with seven peripheral joint infections.
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« Reply #47 on: October 28, 2012, 09:00:37 PM »

http://www.boston.com/whitecoatnotes/2012/10/26/fda-mold-seen-vials-the-steroid-linked-fungal-meningitis-outbreak/TaUeg5iz5PWUaLEedmhdAI/story.html
FDA: Mold seen in 83 vials of the steroid linked to fungal meningitis outbreak
October 26, 2012

The US Food and Drug Administration found visible mold inside the Framingham pharmacy at the center of the national fungal meningitis outbreak, including 83 vials from one lot of the tainted steroid used to treat back pain that contained “greenish black foreign matter.’’

An additional 17 vials in that bin of 321 vials of methylprednisolone acetate had white fibers floating in them during the inspection. FDA investigators visited New England Compounding Center over seven days between Oct. 1 and Oct. 26, which was after the steroid was recalled by the company.

Other vials from this lot had already been sent out to clinics around the country, to be used for back and joint injections, between Aug. 17 and Sept. 25.

The agency Friday afternoon released a form called a 483, which is issued at the end of an inspection when investigators believe that they have observed conditions or practices that may violate the federal law.

New England Compounding did not do proper sterility testing on the steroid, the report said, sending out just one vial from the entire lot for testing -- a vial that passed the test. But when the FDA tested 50 vials, it found contamination in all of them. Experts say a minimum of 20 should be tested under national guidelines.

The FDA also found greenish yellow or other discoloration inside autoclaves, which are used to sterilize vials, stoppers, and compounded drugs.

The company’s own environmental testing showed bacteria and mold in numerous spots in two “clean rooms” -- where sterile drugs are prepared -- at the pharmacy between January and September of this year that were above New England Compounding’s own “action limits.” But there is no evidence that the company investigated further or took corrective measures, the report said.

And, the company did not assess whether products made in the rooms on the days samples were taken could have become contaminated.
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« Reply #48 on: October 30, 2012, 04:55:21 PM »

http://www.reuters.com/article/2012/10/30/us-usa-health-meningitis-deaths-idUSBRE89T1HX20121030
Three more deaths from meningitis outbreak linked to injections
October 30, 2012

(Reuters) - Three more patients have died after contracting fungal meningitis from potentially tainted steroid injections supplied by a Massachusetts company, the U.S. Centers for Disease Control and Prevention said on Tuesday, bringing the death toll from the outbreak to 28 nationwide.

Two of the new deaths were in Michigan, which now has reported seven fatalities, and one in Tennessee which has confirmed 11 deaths, the CDC said. The two states have been the hardest hit by the outbreak, first discovered in Tennessee late last month.

The number of cases of fungal meningitis reported across the United States rose to 356 on Tuesday, up nine from Monday, the CDC said. Nineteen of 23 states that received shipments of the steroid have reported cases.

There also are seven reported cases of infections after the steroid was injected into a joint such as a knee, hip, shoulder or elbow, bringing the total number of infections to 363.
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« Reply #49 on: October 31, 2012, 07:39:29 PM »

http://abcnews.go.com/Health/Wellness/meningitis-outbreak-368-cases-29-deaths/story?id=17609742
Meningitis Outbreak: 368 Cases, 29 Deaths
October 31, 2012

Another person has died from a fungal meningitis outbreak tied to tainted steroid injections, bringing the total death toll to 29, health officials reported today.

The U.S. Centers for Disease Control and Prevention has increased the tally of cases to 377. That's 368 cases of fungal meningitis and nine joint infections. Rhode Island became the 18th state affected by the outbreak on Monday.
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« Reply #50 on: November 02, 2012, 07:14:57 PM »

http://abcnews.go.com/Health/meningitis-outbreak-404-cases-29-deaths/story?id=17629376
Meningitis Outbreak: 404 Cases, 29 Deaths
November 2, 2012

Eighteen more people have been diagnosed with fungal meningitis in an outbreak linked to tainted steroid injections, health officials reported today.

The U.S. Centers for Disease Control and Prevention increased the tally of cases to 404 in 19 states: 395 cases of fungal meningitis and nine joint infections. At least 29 people have died.
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« Reply #51 on: November 03, 2012, 02:03:07 PM »

http://www.nytimes.com/2012/11/03/health/second-illness-infects-meningitis-sufferers.html
Second Illness Is Infecting Those Struck by Meningitis
November 2, 2012

Just when they might have thought they were in the clear, people recovering from meningitis in an outbreak caused by a contaminated steroid drug have been struck by a second illness.
The new problem, called an epidural abscess, is an infection near the spine at the site where the drug — contaminated by a fungus — was injected to treat back or neck pain. The abscesses are a localized infection, different from meningitis, which affects the membranes covering the brain and spinal cord. But in some cases, an untreated abscess can cause meningitis. The abscesses have formed even while patients were taking powerful antifungal medicines, putting them back in the hospital for more treatment, often with surgery.

The problem has just begun to emerge, so far mostly in Michigan, which has had more people sickened by the drug — 112 out of 404 nationwide — than any other state.
 ::snipping2::
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« Reply #52 on: November 05, 2012, 04:42:38 PM »

http://abcnews.go.com/Health/meningitis-outbreak-419-cases-30-deaths/story?id=17645227
Meningitis Outbreak: 419 Cases, 30 Deaths
November 5, 2012

Fifteen more people have been diagnosed with fungal meningitis in an outbreak linked to tainted steroid injections, health officials reported today.

The U.S. Centers for Disease Control and Prevention said it now counted 419 cases in 19 states: 409 cases of fungal meningitis and 10 joint infections. At least 30 people have died.
 ::snipping2::
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« Reply #53 on: November 05, 2012, 05:35:51 PM »

http://www.reuters.com/article/2012/11/05/us-usa-health-meningitis-congress-idUSBRE8A41HR20121105
Congressional panels to hold hearings on meningitis outbreak
November 5, 2012

(Reuters) - Two congressional oversight committees will hold hearings next week on the deadly U.S. meningitis outbreak linked to tainted steroid injections and one panel has invited an official from the compounding pharmacy involved, aides said on Monday.

The House of Representatives Energy and Commerce Committee expects to hear testimony from Food and Drug Administration commissioner Margaret Hamburg on November 14.
 ::snipping2::
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« Reply #54 on: November 05, 2012, 06:53:20 PM »

http://www.webmd.com/pain-management/news/20121105/spine-infections-fungal-meningitis-survivors
Spine Infections Hit Fungal Meningitis Survivors
Dangerous 2nd Infection in Tainted-Shot Outbreak

November 5, 2012
Nov. 5, 2012 -- As many as a third of people suffering fungal meningitis linked to tainted steroids -- and others who did not get meningitis -- are coming down with dangerous infections in the spine.

Some of these dangerous infections are epidural abscesses: pockets of fungus growing inside the spine. Others are arachnoiditis, a deeper and more serious infection. Both kinds of infection can be crippling or fatal. A few of these infections were seen at the beginning of the outbreak. Now many more cases are popping up.

In some cases, these infections are the first signs of disease in people who received fungus-contaminated spinal steroid injections, says CDC fungal disease expert Tom M. Chiller, MD.

Many of the spine infections are in people who seemed to be recovering from life-threatening fungal meningitis.


"Some of these people were called in, diagnosed with meningitis, and treated. Their meningitis symptoms were improving," Chiller says. But then these patients reported pain in specific parts of the spine. Imaging studies showed they had these pockets of infection.

"We don't have a good handle on why that is," Chiller says. "This is an unprecedented event, injecting fungus into the [inside of the spine], and the disease is manifesting in many ways."
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« Reply #55 on: November 07, 2012, 07:35:11 PM »

http://online.wsj.com/article/SB10001424127887324073504578105412195419472.html
Head of Massachusetts Pharmacy Board Fired
November 7, 2012

 ::snipping2::
James Coffey, director of the Massachusetts Board of Pharmacy, failed to follow up on a complaint from the Colorado pharmacy board accusing New England Compounding Center of illegally selling medicines without a prescription, the Massachusetts health department said in a statement.

After investigating NECC's sales to hospitals in Colorado, that state's health department last year issued a "cease and desist" order to the pharmacy. In July, a Colorado inspector sent the order as well as other materials to Mr. Coffey, who pledged to follow up, according to his emailed reply.

Steroid injections made by NECC, based in Framingham, Mass., have been linked to an outbreak of an unusual fungal meningitis that has sickened 424 people in the U.S. and killed 31.

Lauren Smith, the Massachusetts health department's interim commissioner, said in a statement that it was "incomprehensible" that Mr. Coffey didn't follow up on Colorado's complaint given previous concerns raised about NECC's and the board's responsibility to investigate complaints.
 ::snipping2::
Susan Manning, a Massachusetts pharmacy board lawyer to whom Mr. Coffey forwarded the Colorado complaint but who also allegedly didn't take any action, was placed on administrative leave pending the conclusion of the state investigation, the state health department said.
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« Reply #56 on: November 08, 2012, 09:33:47 AM »

I've been watching and changing the subject line on the header of this thread  to adjust the number of cases and the number of dead, and it's getting scary.  I wonder how many may be out there that aren't in the count, like the ones that authorities haven't been able to contact or those that may have died from another injury or illness and the meningitis contributed, but it wasn't known at the time etc.?  What does the future hold for those that have received the injections and even though they aren't showing signs of meningitis at this point?  Could it rear it's ugly head later in life?  And the patients that are being treated for meningitis and other complications from the injections, what of their lives?  Even with treatment, no one really knows.   

http://www.dailymail.co.uk/news/article-2229648/Meningitis-death-toll-rises-31-424-cases-reported-U-S-MORE-expected.html
Meningitis death toll rises to 31 with 424 cases reported in the U.S.
November 8, 2012
Yet another fatality in a fungal meningitis outbreak  linked to tainted steroid injections has been reported, bringing the confirmed death toll to 31 with 424 cases reported in the multistate scourge.

The U.S. Centers for Disease Control and Prevention released new tallies today without identifying the latest death.
 ::snipping2::
The CDC initially said the risk of meningitis was highest in the 42 days following the injection -- a six-week stretch that theoretically ended today, since the suspect steroids were recalled Sept. 26. But new cases will continue to trickle in, according to the agency.

'Forty-two days is not a magic number by any sense of the word,' Dr. Tom Chiller, a fungal disease expert at the CDC, told ABC. 'This is a moving target. The outbreak is evolving'
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« Reply #57 on: November 13, 2012, 08:43:59 PM »

http://www.cbsnews.com/8301-18563_162-57549404/president-of-firm-linked-to-meningitis-outbreak-to-testify-before-congress/
President of firm linked to meningitis outbreak to testify before Congress
November 13, 2012

(CBS News) WASHINGTON, D.C. -- The president of the New England Compounding Center (NECC) will be called to testify on Capitol Hill Wednesday about the deadly meningitis outbreak linked to contaminated steroid shots distributed by the company.
"I have a right to say there's a debacle here. There's malfeasance. Somebody's culpable," says Rep. Cliff Stearns, R-Fla., who chairs the House Energy and Commerce subcommittee that is investigating the outbreak. "Come to me and explain why 32 Americans have died, 450 are in the hospital. Tell me what happened."

Stearns says he expects NECC president Barry Cadden to remain silent and take the Fifth Amendment.

More than 400 patients in 19 states have been diagnosed with meningitis. Meanwhile, federal investigators found insects, birds and leaky ceilings at a second drug manufacturer that is linked to the NECC.
"There was clear evidence that the quality control was terrible at the New England Compounding Center and he was doing nothing about it," Rep. Stearns says of NECC president Cadden. "So for some reason, he was camouflaging and trying to indicate to the FDA that there was no problem. ... I think obviously he was shading the truth."

Stearns plans to examine an incident in September 2004 when Cadden was asked by an FDA investigator if NECC had "Trypan Blue" -- a product that is not approved by the FDA -- in stock. Cadden said it did not, according to the investigator, who then reported finding 189 vials of it on site.

"So I think the FDA has a lot to explain here, because at this point all of us are just aghast at the number of people that have died, as well as a huge number of people who ended up in hospitals," Stearns says.

Strearns says he plans to question FDA Commissioner Dr. Margaret Hamburg about why the agency dropped investigations into the "Trypan Blue" incident and another incident two years before, when at least two people developed septic shock after being injected with a drug made by NECC.
 ::snipping2::
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« Reply #58 on: December 02, 2012, 07:28:40 PM »

http://www.wbur.org/2012/12/01/meningitis-grand-jury
Report: Grand Jury Investigating Pharmacy In Meningitis Outbreak
December 1, 2012

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« Reply #59 on: December 06, 2012, 08:22:59 PM »

http://www.boston.com/whitecoatnotes/2012/12/06/massachusetts-officials-find-problems-three-more-compounding-pharmacies/oMwdqoKzoFnpyGXl5ot0TK/story.html
Massachusetts officials find problems at three more compounding pharmacies
December 6, 2012

Three compounding pharmacies found to have problems in how they prepared or stored drugs have received cease and desist notices from the state Department of Public Health, as part of its ongoing surprise inspections of pharmacies that prepare sterile drugs used in injections. But none of their products has been recalled.

At the same time, the state announced Thursday the appointment of three new pharmacy board members from a variety of health care backgrounds, and said a commission that plans to make recommendations to Governor Deval Patrick by the end of the month is considering changes in the board’s structure that could ensure more members come from outside the pharmacy industry.

“The issues that were identified did not necessitate a recall; it was more around some of the production approaches,” said Dr. Lauren Smith, interim commissioner of the Department of Public Health. “At this point, the rationale for interrupting or requiring the pharmacies to cease their operations is so the investigation can continue”

The state began unannounced inspections after contaminated steroids produced by New England Compounding Center of Framingham were blamed for the national meningitis outbreak, which has resulted in at least 36 deaths. In October, regulators shut down Infusion Resource, a Waltham compounding pharmacy. That company is still closed and the investigation is ongoing, a spokesman for the state health agency said.

Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, said only a small number of his members do sterile compounding.
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