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 Fungal meningitis outbreak 
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Post Fungal meningitis outbreak
Fungal Meningitis Outbreak: Pharmacy Linked To Outbreak Issues Voluntary Recall Of All Of Its Products

The pharmacy that distributed a steroid linked to an outbreak of fungal meningitis has issued a voluntary recall of all of its products, calling the move a precautionary measure.

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The Centers for Disease Control and Prevention posted updated figures to its website Sunday showing there are 91 confirmed cases of the rare form of fungal meningitis. The outbreak spans nine states and has killed at least seven people.

The states with reported cases are: Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia.

The steroid linked to the outbreak had already been recalled, and health officials have been scrambling to notify anyone who may have received an injection of it. The Massachusetts pharmacy that made it has said it is cooperating with investigators.

It is not yet known exactly how many people may have been affected, though it could affect hundreds or even thousands of people who received the steroid injections for back pain from July to September.

con. http://www.huffingtonpost.com/2012/10/0 ... 46843.html

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Thu Oct 11, 2012 6:07 am
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Post Re: Fungal meningitis outbreak
CDC leads fight against meningitis outbreak

The emergency operations center is bustling at the Centers for Disease Control in Atlanta, where scientists recently learned that the fungus linked to a multistate outbreak of lethal meningitis is actually two fungi.

That means the CDC must revise the treatment protocol and advise doctors in the 23 states with potential victims to switch to a broader spectrum of drugs.

“We’re still discovering what we’re up against,” said Dr. Benjamin Park, who is leading the CDC investigation.

The scene recalls images of NASA’s mission control center. Workers sitting at long long tables look up at an array of large screens with maps pinpointing confirmed cases and deaths.

Dr. John Jernigan, a CDC epidemiologist, has assembled a team of the world’s leading experts in fungal infections. They spent Tuesday clarifying which patients are in the gravest danger. Many of those afflicted with the disease are elderly, he said.

As of Wednesday afternoon, there were 137 cases and 12 deaths across 10 states. Tuesday’s tally was 119 cases and 11 deaths.

“This is a rapidly evolving situation,” Jernigan said.

This isn’t your garden variety meningitis. Fungal meningitis is rare; there isn’t much scientific research or treatment guidance to fall back on.

Health officials have traced the outbreak to a steroid used in pain injections. It was formulated by one company in Massachusetts and delivered to 75 clinics in 23 states nationwide.

snip

there’s some good news thus far: The great majority of potential victims have been contacted, and most of those who have been tested were not infected. Also, this form of meningitis is not contagious.

The bad news is that new cases are emerging virtually every day. Patients may not feel symptoms for up to a month after the steroid injections, which officials believe were administered between May and September. So more cases may show up in coming weeks.

“We expect to hear about more deaths,” Park said.

con. http://www.ajc.com/news/news/cdc-leads- ... eak/nSZk8/

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Thu Oct 11, 2012 6:12 am
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Post Re: Fungal meningitis outbreak
New allegations in deadly meningitis outbreak

The specialty pharmacy linked to a deadly meningitis outbreak may have misled regulators and done work beyond the scope of its state license, Massachusetts Gov. Deval Patrick said Wednesday.

That pharmacy also settled a lawsuit alleging it produced a tainted shot that caused a man's death in 2004.

Meanwhile, a second pharmacy connected to the New England Compounding Center in Framingham has shut down for state and federal inspection, and was accused by a business customer this summer of failing to separate sterile and non-sterile supplies, a charge the company denies.

The Framingham-based compounding center made a steroid that was used in injections for back pain that were later found to be contaminated. More than 130 people in 11 states have been sickened. Twelve have died.

On Wednesday, Patrick told reporters that state and federal agencies "may have been misled by some of the information we were given" by the compounding center.

The company was licensed to fill specific prescriptions for specific patients but exceeded that, he said.

"What they were doing instead is making big batches and selling them out of state as a manufacturer would, and that is certainly outside of their state license," he said.

Massachusetts U.S. Rep. Ed Markey seized on Patrick's statement and sent a letter to the U.S. Food and Drug Administration, asking if it believes it was misled by the company.

"This company may have disregarded federal guidelines, and we need to know from the FDA whether the company misled regulatory authorities and if sanctions against the company are available or warranted," Markey said.

A company spokesman declined comment beyond a statement that company officials are focused on cooperating with the investigation. The company has shut down operations, recalled the fungus-contaminated steroid and is cooperating with investigators.

On Wednesday afternoon, the state announced that the pharmacy Ameridose had agreed to temporarily shut down, pending inspection by state and federal regulators.

Ameridose was founded in 2006 by Greg Conigliaro and Barry Cadden, who opened the New England Compounding Center eight years earlier.

Ameridose said in a statement that its shutdown ends Oct. 22, though the agreement with the state allows the shutdown to be extended or shortened. The step is being taken as a precaution, not because of evidence of contamination, officials said Wednesday.

Dr. Madeleine Biondolillo, director of the state's Bureau of Healthcare Safety, said there's no evidence of problems at Ameridose and the state hasn't requested a recall of any Ameridose products.

Ameridose said that, as part of the agreement, Cadden has resigned all corporate positions with the company, where he has not had a day-to-day role.

Andrew Paven, a spokesman for both companies, said, "Ameridose is a separate entity from New England Compounding Center, with distinct operational management."

Allegations of a shot tainted with a different form of meningitis were at the heart of a lawsuit filed against the New England Compounding Center over the 2004 death. An 83-year-old man died about a year-and-a-half after receiving a shot produced by the company.

The 2004 lawsuit filed in upstate New York's Monroe County claimed that New England Compounding Center produced the shot that infected William Koch with bacterial meningitis at Rochester General Hospital on July 17, 2002. Koch died Feb. 28, 2004, at the age of 83.

The lawsuit complaint said the shot was the source of Koch's meningitis, but did not explain how that determination was made.

Bacterial meningitis is contagious and much more common than the fungal meningitis involved in the current outbreak. Fungal meningitis is more difficult to catch, according to the Centers for Disease Control.

The compounding pharmacy reached a settlement with Koch's widow in 2007 before the case went to trial, according to her lawyer Mark S. Nunn. He declined to elaborate Wednesday because the terms were confidential.

snip

A pharmacy manager at Ameridose, Sophia Pasedis, has been a member of the regulatory body, the Massachusetts Board of Registration in Pharmacy, since 2004. But the state said she has recused herself from all matters related to Ameridose and the New England Compounding Center.

Compounding pharmacies supply products that aren't commercially available, based on an individual doctor's prescription. Some have grown into larger businesses, operating across state lines and supplying drugs to thousands of hospitals, clinics and physicians.

Biondolillo said the state has reminded Massachusetts pharmacies that compounding can be done only in response to a patient-specific prescription. She said the state is now requiring all compounding pharmacies to sign an affidavit that they are following all regulations.

The state has 1,100 pharmacies that can compound drugs.

snip

Read more here: http://www.cbsnews.com/8301-204_162-57530279/new-allegations-in-deadly-meningitis-outbreak/?tag=AverageMixRelated

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Thu Oct 11, 2012 10:24 am
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Post Re: Fungal meningitis outbreak
This is a no brainer for MMS [no pun intended!!]


:popcorn

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Thu Oct 11, 2012 11:18 am
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Post Re: Fungal meningitis outbreak
Hat tip to Treyfish

More drugs implicated in fungal meningitis outbreak

Two more drugs have been implicated in the ongoing outbreak of fungal meningitis linked to contaminated pain injections, federal health officials said Monday.

Both come from the same pharmacy, New England Compounding Center, that distributed the steroids suspected of sickening at least 214 people and killing 15 of them, the Food and Drug Administration said in a statement.

One is a steroid called triamcinolone acetonide and another is a product used during heart surgery. While the FDA hasn’t confirmed that the two products are to blame, it’s issued a warning.

snip

Until now, just three lots of methylprednisolone made by NECC had been suspected – but as many as 14,000 patients were treated with steroid from those three batches.

“In addition, two transplant patients with Aspergillus fumigatus infection who were administered NECC cardioplegic solution during surgery have been reported,” the FDA added. “Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.”

Con. http://vitals.nbcnews.com/_news/2012/10 ... id=twitter

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"The world will not be destroyed by those who do evil, but by those who watch them without doing anything." ~ Albert Einstein


Mon Oct 15, 2012 2:17 pm
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Post Re: Fungal meningitis outbreak
Insight: Red flags ignored for years at firm in meningitis crisis


By Toni Clarke and Sharon Begley

BOSTON | Fri Oct 26, 2012 3:41pm EDT

(Reuters) - A cracked vial here, a missing label there. The complaints coming into New England Compounding Center, the firm at the heart of the deadly U.S. meningitis outbreak, were piling up.

In March, regulators responded to a complaint from the prestigious Massachusetts Eye and Ear Infirmary about a potency concern involving one of the eye medications it purchased from NECC. The investigation is ongoing.

Over the summer, physicians at Ruby Memorial Hospital in West Virginia returned a bag of cardioplegia solution used in heart surgery after a patient did not respond as expected.

Testing showed the drug was not responsible, according to the hospital's pharmacy director, but the episode made at least one NECC sales representative uneasy.

"I remember thinking, are we just selling too much?" he said. "Were we growing sales faster than our lab could handle?"

snip

Read more here: http://www.reuters.com/article/2012/10/26/us-usa-health-meningitis-necc-idUSBRE89P12N20121026

When are we going to learn that bigger is not always better?

When will we learn that "growing sales" may not be such a good thing?

:gah

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Sat Oct 27, 2012 7:21 am
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